Manufacturing Technical Resume Samples

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M Dicki

Marquise

Dicki

800 Tanya Flats

Philadelphia

+1 (555) 747 1860

800 Tanya Flats

Philadelphia

Phone

p +1 (555) 747 1860

Experience Experience

San Francisco, CA

Manufacturing Technical Specialist

San Francisco, CA

Hickle-Grady

San Francisco, CA

Manufacturing Technical Specialist

Work on manufacturing engineering projects relative to cost reduction, product redesign, and manufacturing quality
Drive team to work on manufacturing engineering projects relative to cost reduction, product redesign, and manufacturing quality
Design and drive engineering projects to completion, partnering with Quality Director to support company fresh-lot and manufacturing goals
Development and execution of training materials for new processes and equipment in conjunction with the site technical training team
Develop and maintain working relationship with cross-functional peers, including Technical Support, Quality and Supply Chain
Provide senior level leadership to WW engineering group, to help drive efficiencies and lean engineering process
Authoring of minor equipment and facility change controls, MBR revisions, and CAPA Action Plans

New York, NY

Upstream Manufacturing Technical Leader

New York, NY

West-Jast

New York, NY

Upstream Manufacturing Technical Leader

Technical trainer for the shift – provides consistent training to the staff Execute and drive continuous improvements
May provide scheduling and work assignment guidance to peers
Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team
Weighs and checks raw materials
Assigned area owner – drive facility upkeeps
Investigation identifiers – initiate investigation following alignment with QA floor
Adheres to Good Manufacturing Practices and standard operating procedures

present

Philadelphia, PA

Purification Manufacturing Technical Lead Nights

Philadelphia, PA

Jenkins, Skiles and Reinger

present

Philadelphia, PA

Purification Manufacturing Technical Lead Nights

present

Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action
Execute and drive continuous improvements
Maintains a professional and productive relationship with area management and co-workers
Participate in performance review discussion
Assists with the coordination and implementation of special projects such as validation or complex investigations
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
Leads complex investigations on floor – drives technical issues in working with cross functional team members

Education Education

Bachelor’s Degree in Engineering

Georgia Southern University

Bachelor’s Degree in Engineering

Skills Skills

Lead manufacturing process implementation for new product introduction including
Identifying and mitigating critical manufacturing issues early with the engineering teams
Work closely with cross functional departments to ensure seamless processes/adherence to AME best practices
Work with senior members on manufacturing engineering projects relative to cost reduction, product redesign, and manufacturing quality
Design and drive engineering projects to completion, partnering with cross functional teams to achieve manufacturing goals
Operate various equipment in test lab
Evaluate, document, and improve manufacturing methods
Areas of Focus
New Technologies: Scaling new manufacturing technologies and materials for mass production at oversea suppliers and partners
FEA: Perform Finite Element Analysis simulations to model experimental results

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15 Manufacturing Technical resume templates

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Manufacturing Technical Assistant Resume Examples & Samples

Mfg. technical assistant/Operator is responsible for all aspects of the production process, including: material handling, equipment operation, assembling, warehousing, and various support activities. The operator position duties and responsibilities can change regularly based on the plants need
Work under the guidance of Supervisor to perform and complete the assigned duties in timely manner
Produce the required quantity in the highest quality minimizing the raw material, in process and finish product scrap following the manufacturing procedures
Recommend process improvements to enhance operational efficiency and safety
Follow safety procedures and company policies for all manufacturing operation/activities
Identify and report unsafe operations to Supervisor immediately
Troubleshoot problems if/as they arise both mechanically and electrically including all production equipment, using hand tools and power tools
Secondary technical school with preferably electrician or mechanical certification
User level computer skill
English language
Must be available to work rotating shifts, weekends, call-outs and overtime
Certificate of forklift truck operations
Experience in maintenance type of activities

Manufacturing Technical Supervisor Resume Examples & Samples

Have a Bachelor of Science or Engineering (Mechanical and Electrical degree are preferred)
Less than 18 moth experience from the graduation date
Able to work on night shift
Demonstrate passion in managing and leading diverse group of technicians to deliver quality output safely
Able to provide leadership to technicians to resolve problems and require strong process knowledge
Able to motivate and develop workforce to meet business challenges
At least three to five years of experience managing people in the manufacturing organization is preferred however fresh graduates are also encouraged to apply
Must speak Vietnamese and English fluently

Manufacturing Technical Supervisor Resume Examples & Samples

The candidate should hold a bachelor or above degree of engineering
Good communication skills at both verbal/written English and Mandarin
Good interpersonal and some stakeholder management skills is demonstrated
Good problem solving skills and pay attention to details
Experience/internship in working in a high volume factory is preferred

Manufacturing Technical Specialist Resume Examples & Samples

Provide senior level leadership to WW engineering group, to help drive efficiencies and lean engineering process
Develop sustainable systems and processes to manage service of the device requirements
Drive team to work on manufacturing engineering projects relative to cost reduction, product redesign, and manufacturing quality
Design and drive engineering projects to completion, partnering with Quality Director to support company fresh-lot and manufacturing goals
Develop, evaluate, document, and improve manufacturing methods
Lead process implementation for new product introduction
Work closely with cross functional departments to ensure seamless processes/adherence to policies
Work on manufacturing engineering projects relative to cost reduction, product redesign, and manufacturing quality
A Bachelor’s degree in Engineering
7+ years of experience in business process improvement required. Lean/Six Sigma
Experience with Camera, Display, Test, Mechanical or Electrical Engineering
Previous program management experience working in a global environment
Experienced in identifying and communicateing risks to stakeholders, define risk mitigation strategies, and facilitate appropriate business and software solutions
Experienced in liaising with team leaders and executives to ensure that the project planning is optimal, well managed, and clearly communicated
Must be willing to travel 25%-40% as necessary to meet objectives
Advance Engineering degree and /or MBA
7+ years of experience in business process improvement
Experience with Lean/Six Sigma, Camera, Display, Test, Mechanical or Electrical Engineering
Strong group facilitation skill and exceptional communication skill

AD Manufacturing & Technical Ops Resume Examples & Samples

Provide engineering or technology support for development, technology transfer and commercial production of Drug Substance
In collaboration with contractors, collect and trend process, analytical and stability data and ensure discrepancies are investigated
Collaborate with contract manufacturers during development, production and testing of product. This may include scheduling and running teleconferences, generation and distribution of meeting minutes to project team. If necessary, debottleneck and rationalise processes to optimise processes consistency, yield, and robustness
Assist in preparation of documentation to support key development and regulatory milestones such as preparation of BLA, PAI, CBE and PAS submissions and fulfilment of post marketing commitments
Bring scientific and technical expertise to the organisation as well as remaining current with latest technologies
International travel of up to about 2 weeks at a time will periodically be required
Have a familiarity with quality systems and both FDA and EU regulations as they relate to process / product development and manufacture of biologics
You have knowledge of process characterisation activities and Quality by Design (QbD) principles
Demonstrated track record of delivering timely and consistent results and familiarity with project management skills for technical programs
Bachelor's degree in engineering or an applied science is required. An advanced degree is preferred
Over five years of relevant pharmaceutical development and manufacturing experience in Biologics

Manufacturing Technical Specialist Upstream Technical Operations Resume Examples & Samples

Lead aspects of Gilead's Biologics Cell Culture Technical Operations to ensure timely and successful technology transfer of upstream manufacturing processes, both internally and externally
Lead and/or assist with multiple technology transfers in parallel. Independently troubleshoot or seek guidance as needed
Experience with Upstream Bioprocessing equipment and operations from thaw through harvest. In-depth understanding of Cell Culture scale-up, engineering principles, and associated equipment - ie growth rates, specific consumption/production rates, bioreactor design and geometry, power calculations, gas flow/velocities, shear stress, etc
Work closely with Gilead's Biologics Quality and Operations teams, and provide routine Technology Transfer progress updates to internal and external technical teams. Collaborate with Gilead's Biologics Outsourcing group to ensure timelines, deliverables, and business operations are aligned and met. Ensures adherence to budgets, schedules, and performance requirements
Lead technical discussions and influence stakeholder acceptance of critical process- and quality- based decisions
Ensure that appropriate process data are recorded and analyzed to monitor run-to-run consistency for Upstream operations across internal and CMO production campaigns
Present and document Cell Culture Manufacturing Technology transfer status/updates and monitoring/trending of historical process performance, and tech transfer/campaign summary reports
In-depth understanding of cGMP requirements for commercial manufacturing, experience with assisting in the generation of relevant regulatory sections of BLA and MAA filings, data capture and management, process monitoring and trending including control charting and statistical process control, and supporting regulatory and site inspections
Lead upstream manufacturing technical training internally and at CMO facilities to support process transfer, scale up and commercialization
Identify process gaps and facility fit issues, implement remediation plans, and generate solutions to ensure successful scale-up and process fit into CMO plants
Accountable for monitoring process performance/process history and assessing process deviations both internally and at CMO sites
Leverage technical expertise to lead investigations/ author reports to support close-out of deviations and troubleshoot process excursions/issues for cell culture operations
Travel routinely for meetings focused on upstream technology transfer and person-in-plant support during manufacturing campaigns at the CMO of choice
Support regulatory inspections and routine site audits as a process-specific Subject Matter Expert
Contributes to the completion of all technical support activities related to maintaining commercial product supplies through management of internal and external resources
Contributes to processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements
Contributes to technical investigations of process deviations, and assessment of their impact on product quality. Defines requirements for, and reviews master batch records prior to release approval by manager
Contributes to the user requirement specification, and provides process technical support to the utilization and validation of new and improved
Liaises with manufacturing groups to deliver new and improved drug products and processes
Interfaces with contract manufacturers to address standard documentation and compliance issues
Can lead one or more specific components of departmental strategic initiatives. Focuses on a specific area of responsibility or specialization such as a new production process, specific technology in lab or new product release
Performs investigations as required to support commercial products
Revises, improves or develops new methods to support commercial products; writes protocols and reports
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed
Provides high-level analytical support for one or more major functions within the department
May provide technical guidance and training to team members
5+ years of relevant experience and BS in a relevant scientific discipline
4+ years of relevant experience and an MS in a relevant scientific discipline
Demonstrates knowledge of regulatory guidance documents (i.e. SUPAC, PACPAC)
Prior experience in Cell Culture Technical Operations/MSAT
Experience with biologics technology transfer to contract manufacture sites and/or between internal manufacturing sites
Familiar with monoclonal antibody cell culture platform processes, including cell banking, thaw through production and primary recovery, including centrifugation and depth filtration
Process experience from bench scale through pilot and commercial scale (10,000L – 20,000L) required
Knowledge of cGMPs, ISO standards, ICH guidelines and regulatory CMC requirements in all stages of development a plus
Experience in late stage clinical manufacturing, BLA and/or MAA filing, Qualification Campaign Execution, Regulatory Approval and Commercial Campaign support desired
Leadership and management experience will be required for this position
Autonomy in decision making, a self-managed and motivated approach and excellent communication skills will be key attributes to the candidate of choice
Routine travel is a requirement of this role

Purification Manufacturing Technical Lead Nights Resume Examples & Samples

Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. – striving for right first time through adherence of GMP activities
Change control identifiers – works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation
Communicate and resolve operational variances
Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team
Leads complex investigations on floor – drives technical issues in working with cross functional team members
Technical trainer for the shift – provides consistent training to the staff
Support Tech transfer team through active participation in ensuring that new process can fit and executes in sustainable manner
Assists with the coordination and implementation of special projects such as validation or complex investigations
Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
1603820

Purification Manufacturing Technical Lead Days Resume Examples & Samples

Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations
B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired
Demonstrated experience in solving complex technical issues in biologics manufacturing
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
1603819

Manufacturing Technical Administrator Resume Examples & Samples

Creating product travelers for hardware to be built in assigned labs
Generating serial numbers and labels for equipment to be built as applicable. Maintaining database of serial numbers and update regularly
Receiving material kits and subassemblies from suppliers (stockroom, other labs, etc.). Auditing material to ensure completeness and accuracy before releasing to lab. Maintaining log of receipts
Maintaining status of work in process (WIP) in lab. Perform regular physical inventory checks of WIP to ensure accuracy of WIP status. Updating status reports regularly. Maintaining status availability to others
Performing packaging and documentation of product leaving the lab, either to another lab or to a customer. Delivering hardware to next process. Archiving applicable documentation
Maintaining controlled documentation within lab with emphasis on revision control
Reviewing and implement change notices as necessary. Providing briefing to affected individuals on impact of change notice. Maintaining training records associated with change notice implementation
Performing regular 5S audits in assigned labs. Analyzing data and generate score. Posting scores and trends in labs. Providing reports to others
Managing calibration of equipment in assigned labs. Maintaining calibration database. Ensuring all equipment in use is within calibration. Coordinating re-calibration of equipment as required. Working with calibration department to ensure equipment is being processed effectively
Maintaining process training log for assigned labs while providing training reminders to individuals as required
Providing reports to others in a matrix organization

Manufacturing Technical Manager Resume Examples & Samples

Plan and meet the build plans to effectively transfer products into high volume production
Drive notable YOY improvements in Key Performance Indicators
Meet and exceed business expectations, and set targets
Deliver world class user experience by establishing optimal manufacturing solutions for device assembly
Partner with engineering, and commodity team to risk mitigate new technology deployment to production
Plan and manage all manufacturing NPI equipment budget
Develop strategy to manage NPI risk
Establish and deploy SOP that includes Quality tool utilization i.e. GRR & FMEA
Represent AME team in NPIR, NPI, cost management meetings
Publish progress reports on product readiness to stakeholders
Participate in design reviews of new features through DFM, PFM, functional test development, quality control, and capacity modeling
Develop plans and deploy strategy to optimize NPI at CMs
Bachelor of Science degree in Electrical, Mechanical or related field
Experience in consumer electronics technical project management
5+ years of experience of design, test and /or manufacturing
Experience working with global partners
Familiar with the consumer electronics industry and supply chain
Master's degree in Engineering
Experience in leading technical and cross functional team
Track record of being “hands on” with product during NPI
Ability to start projects and drive to completion
A self starter and deliver tangible results consistently
Drive production readiness process, line qualification, and capable of measurement, gathering and analyzing data
Working knowledge of data analysis and statistics including Minitab
Strong ability to plan capital equipment budget for functional, and device performance testing
Familiar with industry's best practices for related commodities

Manufacturing Technical Manager Resume Examples & Samples

Lead team of test, manufacturing and OEM engineers to introduce new products from engineering to production
Work with OEM’s New Product Operations teams to identify and escalate manufacturing challenges by enforcing DFM and DFT principles
Ensure technical readiness for product ramp and serve as technical lead/advisor to new product ops managers
Develop production strategy, implement and optimize processes at OEM; including identification, specification, design and qualification of fixtures, test equipment and diagnostic software
Develop, review and execute equipment requirement plans to support new product manufacturing and test
Work within Operations, Hardware and Software engineering departments to implement and optimize manufacturing 1st pass yields and efficiency from prototype through product ramp
Work with the design engineering to identify and escalate manufacturing challenges by enforcing DFM, DFA and DFS principles
Investigate and introduce new manufacturing technology and methodology to enhance product quality and production efficiency
Develop manufacturing process at the ODM, including defining fixture requirements, critical dimensions on parts and critical requirements in assembling
Drive all factory-related operational issues related to SMT and final assembly processes during pre-production builds; ensure effective closure to enable operational success of the new product introduction cycle, and put products into mass production
Identify and develop assembly jig and fixture for new products
Bridge the gap from OEM to Amazon by supporting development builds and production
Bachelor’s degree in Electrical Engineering, Mechanical Engineering or similar technical field
7+ years of experience in manufacturing / operations of PCs, handheld devices, or consumer electronics
Program management experience in product introduction and successfully introduced products to volume production
Leadership experience in a cross functional environment
Experience working with International OEM teams
Ability to work independently and ensure timely and accurate communication between the Amazon and our OEM partners
Background in statistical analysis and SPC/DOE

Manufacturing Technical Specialist Resume Examples & Samples

Support the Manufacturing/Testing processes within the Operations department through developing and maintaining expertise in a designated process or technical speciality
To ensure the plant meets its customer quality, service, regulatory, financial and safety goals through effective technical support of Diagnostic products
To provide the necessary support to the product manufacturing team, ensuring that production targets are attained
Develop Subject Matter Expertise, and take lead, in designated change control/process/technical speciality
Train / mentor fellow team members, including peers, as required
Establish oneself as key contact for designated process
Develop and maintain working relationship with cross-functional peers, including Technical Support, Quality and Supply Chain
Provide necessary support to production schedule requirements as designated by Team Leader
Champion the principles and practices of GMP/GLP. Lead by example, and provide mentoring support for team members
Minimise generation of deviations by ensuring that all relevant documentation is being followed and that verification steps are being completed accurately and objectively
Demonstrate an understanding of the application of the Quality Policy through daily activities
Ensure effective communication of process information and manufacturing issues to Team Leader
To ensure that the plant meets the quality requirements of its customers, internal quality systems, internal & external auditors and other external agencies
To liaise with, seek appropriate advice from and report when necessary to colleagues in Lake County, Dartford, Delkenheim and Japan
To assist in preparation of the annual departmental budget
To participate in the AIDD LONGFORD Self-Assessment procedure per site procedures
To assist in the periodic review of controlled documents per site procedures
Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Abbott Global & Technical Standards
Works independently or Individual Contributor
A minimum of 20 months experience in a regulated environment of which 12 months is in the manufacturing/testing or support of diagnostic products
The Manufacturing Technical Specialist is responsible for ensuring that procedures are adhered to and technical issues are resolved. Failure to do so could result in customer complaints, ultimately product recalls and significant financial losses
Individual is given authority to carry out duties without close supervision
Regular team meetings and one-on-one meetings with the Team Leader
Periodic goal reviews, annual performance and career development reviews

Manufacturing Technical Specialist Resume Examples & Samples

Generally requires a PhD or Msc. in engineering or related technical field
2-5 years relevant experience in technical operations or design engineering in a consumer electronics environment
Concise and Precise in Written and Oral communications
Create and present highly technical topics to large and diverse groups
FEA experience
SPC experience (Minitab, JMP)
Run various equipment in an engineering lab with no supervision
MsC or PhD has a focus on Material Science, Mechanical Engineering, Chemical Engineering

Manufacturing Technical Manager Resume Examples & Samples

Education: Bachelor’s degree in engineering or related field
Minimum eight years of plant leadership experience with progressively more responsibility
Food Manufacturing and plant management experience is required

Upstream Manufacturing Technical Leader Resume Examples & Samples

Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. Striving for right first time through adherence of GMP activities
Serve as the “acting” Shift Supervisor/Manager in absence of Shift Supervisor/Manager – Coordinate, direct and oversee work execution and manage personnel related issues
Support real time process reports review and resolve open issues. Trend issues and strives to right first time
Technical trainer for the shift – provides consistent training to the staff Execute and drive continuous improvements
Being resource to support routine investigations and CAPAs– author, review, approval, in case of excess investigation beyond planned capacity
Assigned area owner – drive facility upkeeps
Weighs and checks raw materials
Assembles, cleans and sterilizes process equipment, monitors processes
Operates and trains others all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.)
Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time
May provide scheduling and work assignment guidance to peers
Modifies group work plan, schedule or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, regularly provides training and operational guidance to other staff
Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential

Manufacturing Technical Operations Director Resume Examples & Samples

Will lead a diverse team of Engineers resident in Juniper’s manufacturing facilities including Test, Quality, Manufacturing, and Process engineering
Collaborates with Juniper Global teams to set technical strategy and execution in the manufacturing facilities
Responsible for driving continuous improvement on key process metrics related to the manufacturing including field performance metrics, manufacturing yield programs, Partner scorecard, and throughput metrics
Collaborates with Juniper Supply Change Management team and manufacturing partners to ensure technical resources support Juniper’s production and new product introduction schedules including Juniper and partner personnel, training, tools, and equipment
Drives a high performance team through continuous mentoring and support of team skills and career development
Represents Juniper as a regional leader with internal and external customers

Sourcing Agent Manufacturing & Technical Resume Examples & Samples

Learning the complex needs of assigned sites and establishing credibility with plant management
Challenging the historical supplier base and ensuring that the purchasing process is followed
Driving standardization and leverage across sites that span several business units
Ability to deliver timely results through a newly introduced strategic sourcing process
Capability to manage multiple and changing demands in a resilient and structured fashion
Deliver savings of $ 0.5 to 1.0 MM for the assigned plants. This should be done through individual contribution and through ensuring the implementation of USCA projects
Reduce the number of suppliers in the MRO and plant maintenance areas by 50%. This should involve management of change and collaboration with local stakeholders
Establish a process that all contracts are tendered on a 3 year cycle with 50% of any gaps to be closed by the end of 2017. The process should ensure all bid documentation is accessible
Drive supplier performance through the PPG $ave portal and Service Level Agreements (SLAs). Ensure that 50% of your top 20 suppliers are contributing to save and exceeding their SLA agreements
Develop quarterly communication reviews with each major location. This should involve the review of critical suppliers, upcoming change projects and an understanding of the forward business needs
Ensure that 80% of frequent buying needs are captured within e-catalogues and ensure that item level purchases are proactively classified and routinely analyzed for optimization
Utilize the strategic sourcing process for spends above $ 1.25 MM. This should include proactive involvement of stakeholders and hierarchy. One strategic project should be completed per quarter
As requested, define and lead a specific savings project across USCA. This should be for an area of spend not previously addressed at the USCA level
A bachelor's degree in a technical (chemistry, engineering) or business degree (purchasing/supply chain preferred)
Minimum 5 years sourcing experience within a major manufacturing company
Experience in tackling both CAPEX and OPEX spends
Know-how of establishing contracts, monitoring performance and resolving issues
Organizationally savvy and able to influence and manage conflicts
Structured in initiating and leading change through cross-functional teams
Business acumen to manage commercial relationships and negotiations
Ability to analyze data and to apply strategic frameworks
Natural authority and presence. Able to act with local autonomy
Comfortable with challenge and saying ‘no&#8217
Proactive, hands-on and results-orientated. Embraces getting the job done
Travel 20-40% of the time

Manufacturing Technical Accounting Manager Resume Examples & Samples

General ledger, monthly close process, internal and external audits and company accounting policies
Leading monthly close process for Balance Sheet and P&L
Ensuring balance sheet is compliant. Accounts are reconciled accurately and timely. Assets and Liabilities are properly valued
Driving process improvement across departments
Overseeing Accounts Receivable
Ensuring SOX compliance
Leading the Internal Audit
Controlling the corporate tax packages
Reviewing month end journal entries and account reconciliations
Managing and developing a team of at least five staff
Ensuring Payroll system compliance
Managing the Disbursement Process Driving process improvements and creating new efficiencies
Around 5+ years of manufacturing accounting experience, with at least 1 year of formal supervisory experience
Extensive SOX / Audit experience
Accounting degree from accredited program
An additional degree in Finance

Principal Manufacturing Technical Specialist Resume Examples & Samples

PhD or Msc. in engineering or related technical field
7+ years of relevant experience in technical operations or design engineering in a consumer electronics environment
Written and Verbal communication skills
Experience Creating Intellectual Property, including patents and trade secrets based on process development
Ability to Create and present highly technical topics
SPC experience
Ability to run equipment in an engineering lab with no supervision
MS or PhD has a focus on Material Science, Mechanical Engineering, Chemical Engineering

Intern, Manufacturing Technical Services Resume Examples & Samples

This internship will expose the student to the scale-up, optimization, validation, commercial launch, and lifecycle management of generic solid oral dosage form products through a combination of hands-on manufacturing experiences and complex problem solving
Participate in technical transfer activities between R&D and Commercial Production
Observe large-scale manufacturing activities to gain insight into differences between
Laboratory-scale and production-scale manufacturing environments
Assist with the experimental design and execution of process optimization initiatives
Compile and analyze formulation and manufacturing process information through the development of databases and the application of statistical tools
Develop a working knowledge of Good Manufacturing Practices and Good Documentation Practices and compliance with internal Standard Operating Procedures
Become familiar with the key elements and processes involved in Process Performance Qualification and Product Lifecycle Management
Gain an understanding of technical troubleshooting and formal technical investigation processes
Superior technical competency as demonstrated by excellent academic record
Evidence of achievement and leadership in work and/or extracurricular activities
Strong verbal and written communication skills, personal character, and ethics
Ability to work full-time throughout the internship both independently and as part of a team
The successful candidate will have preferably completed a minimum of their sophomore year and be currently enrolled in an accredited college or university in a Pharmacy, Pharmaceutical Science, Engineering, Chemistry, or related scientific degree program. A minimum 3.0 GPA is strongly preferred, however, a combination of experience and/or education will be taken into consideration

Manufacturing Technical Specialist Resume Examples & Samples

Responsible for the establishment of the processes and activities associated with processing, cleaning, inspection, repair / remediation and maintenance of portable product vessels within the Genentech, Hillsboro Oregon facility
Support the inspection, repair / remediation of all process piping and vessels
Serve as the corrosion control / process surface subject matter expert within the facility
Interface and collaborate with various internal departmental organizations such as Facilities, Engineering, Validation, Quality Assurance, Procurement, and Manufacturing Operations
Interface and collaborate with various external organizations such as Corporate Engineering, Contract Manufacturing facilities, and Genentech Manufacturing Operations on matters of portable product vessel design, modification, and facilitate resolution of issues pertaining to portable product vessels within the Genentech fleet
Maintain clear communications with all internal departments throughout Roche, Genentech and with external contractors, vendors and service providers
Prepare and organize technical documentation, operational and preventive maintenance procedures
Generate Failure Analysis reports and recommend corrective actions
Safely work in close proximity to hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery/equipment
Conduct work in an FDA regulated environment

Manufacturing Technical Specialist Resume Examples & Samples

Investigation and execution low risk Quality Events to support manufacturing operations and providing support for medium and high investigations where required
Authoring of minor equipment and facility change controls, MBR revisions, and CAPA Action Plans
Process and equipment support and troubleshooting
Revision and approval of critical Manufacturing documentation; i.e. MBRs, BOM, and Change Controls
Project validation support and execution
Support and lead Lean OpEx initiatives that align with site strategy
Seek out process inefficiencies and implement solutions
Development and execution of training materials for new processes and equipment in conjunction with the site technical training team
Support of MFG shift operations, Tech Transfers, Process Improvements, and other teams as required
Interact with cross-functional groups to achieve departmental and organizational goals
The position requires a strong understanding of cGMP and regulatory agency requirements and strong technical operational knowledge of the upstream and/or downstream operational unit
Incumbents must have demonstrated experience in solving complex technical issues in Biologics manufacturing, and have the skills and understanding to troubleshoot process equipment and the overall manufacturing process
The role requires an established history of successful participation on diverse work teams where combined contribution, collaboration and results were expected
The position requires excellent written and verbal skills and the ability to provide direction and communicate expectations to the operating staff
The candidate will have strong computer skills and be proficient in the following programs: Word, Excel, Visio, and Project
The position requires the ability to work off-hours as needed to complete projects or key tasks requiring SME oversite
Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired
Direct biologic manufacturing experience of 5+ years
Extensive knowledge of SOPs and GMPs and the know-how to work and manage within a regulated environment
Strong knowledge of biopharmaceutical manufacturing processes
Adaptable to a fast paced, complex and ever-changing business environment
Effective verbal and written communication skills with technical writing skills
Proficiency in the use of computers and business software applications

Biologics Manufacturing Technical Transfer Project Consultant Resume Examples & Samples

Interface with CMOs (contract manufacturing companies), quality, supply chain, development and other partners
Manage scheduling, manufacture, release and logistics of investigational materials to support
Interface with CMOs to manage the technical transfer of pilot plant processes to their facilities
Will work with teams and be responsible for CMO (manufacturing site selection, process fit, request for proposals and business operational documents (CDAs, DSAs etc.)
Will work closely with drug product development group to support manufacturing process development, scale-up and technology transfer activities

VP of Manufacturing Technical Operations Resume Examples & Samples

Responsible for overall Mfg. Technical Operations vision, strategy, and execution
Assess operational goals including metrics for outsourced test, assembly, and quality cost reduction to create the annual budget for Technical Operations
Guide, develop, and support department managers in establishing and achieving goals
Assist the VP of NPI Supply Chain with product sourcing decisions
Build deep relationships with Engineering, Outsourced Manufacturers, OEM Suppliers, Operations, and Customer Support teams to enable smooth deployments of critical products, services, and processes
Coordinate and monitor quality issues that are impacting fields yields and factory output
Liaison with Engineering from the earliest stages of the product lifecycle process from influencing product design to maximum factory automation and product quality
Build expertise on field issues and apply the necessary support resources to meet the challenges while coordinating with other functions as appropriate to develop awareness, determine priorities and define solutions