Manufacturing Technical Job Description

Manufacturing Technical Job Description

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Manufacturing technical provides significant technical expertise to support all aspects of the manufacturing of commercial and cell culture derived biopharmaceutical products at CMOs.

Manufacturing Technical Duties & Responsibilities

To write an effective manufacturing technical job description, begin by listing detailed duties, responsibilities and expectations. We have included manufacturing technical job description templates that you can modify and use.

Sample responsibilities for this position include:

Manage work independently to ensure timely implementation of documentation workflows
Account Plan Development and Manage
Drives innovations and technological advances that improve quality, reduce flow-time, and improve productivity
Works with peers on technology development, manufacturing improvements and resource sharing for the overall benefits of FM&T
Participates in activities to develop technical or administrative solutions to customer expectations
Understands risks associated with product technology maturation at FM&T and works to mitigate those risks
Conducts activities in a safe and health manner and encourages staff to act proactively with regard to themselves, the safety of the manufacturing organization, and the environment
Bring scientific and technical expertise to the organisation remaining current with latest technologies
Write and revise cGMP documentation (Standard Operating Procedures, Production Batch Records and/or Electronic Batch Records) and facilitate the review and approval of documents in a timely manner and within established timelines
Ensure documents are technically accurate and consistent with internal style guidelines for format, clarity, flow, organization, and readability

Manufacturing Technical Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Manufacturing Technical

List any licenses or certifications required by the position: PMP, MBB, MBA, CMA, CPA, IPC, J-STD, DFSS, CP, MPS

Education for Manufacturing Technical

Typically a job would require a certain level of education.

Employers hiring for the manufacturing technical job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Engineering, Science, Technical, Education, Chemistry, Manufacturing, Mechanical Engineering, Management, Biology, Performance

Skills for Manufacturing Technical

Desired skills for manufacturing technical include:

Downstream unit operation
GMP/QSR/FDA/ISO regulations and compliance requirements
Workflows
Bioreactors design and control
Change controls
Deviation reports
Perfusion cell culture
Scientific and engineering principles
Statistical tools
Biopharmaceutical manufacturing processes

Desired experience for manufacturing technical includes:

Experience working in manufacturing and/or at foreign capital companies
Post-graduate qualification (CPA/MBA/Zeirishi/etc)
Bachelor's degree in Mechanical Engineering, Computer Science, or Materials Science
7+ years of experience in business process improvement required
Work with Manufacturing Management and QA Change Control to establish comprehensive implementation plans for document revisions and associated change requests
Establish and maintain tracking metrics for document revisions and provide status updates as needed

Manufacturing Technical Examples

1

Manufacturing Technical Job Description

Job Description Example
Our growing company is hiring for a manufacturing technical. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for manufacturing technical
  • Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintained
  • Change control identifiers – works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation Investigation identifiers – initiate investigation following alignment with QA floor Communicate and resolve operational variances
  • Support real time process reports review and resolve open issues
  • Trend issues and strives to right first time
  • Operates and trains others all production equipment within the assigned functional area
  • Effectively uses process automation systems
  • Lead development, maintenance and continuous improvement of process validation program for all DS and DP manufacturing processes
  • Evaluate existing training materials for efficacy, and support revisions when needed to ensure training is clear, consistent, and effective
  • Complete all Manufacturing training and become a Qualified Trainer on all manufacturing operations
  • Participate in manufacturing activities and identify process improvement and optimization opportunities
Qualifications for manufacturing technical
  • Ability to communicate clearly and effectively through verbal and type-written correspondence (memos and/or e-mail)
  • 3-5 years of direct technical writing experience with at least 2 years’ writing in a Biopharma or Manufacturing related field
  • Experience in a regulated environment where documentation practices follow established regulations and guidelines
  • Proficiency with standard office software applications MS Office Suite software
  • An Associate’s degree or higher in a technical field is desired
  • Ideal candidate will be a self starter
2

Manufacturing Technical Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of manufacturing technical. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manufacturing technical
  • Participate in the process hazard analyses (PHA) for new or modified manufacturing processes and equipment as assigned
  • Assess training needs for new and existing Manufacturing staff members
  • Assist Manufacturing Systems Coordinator, as needed, to ensure training records for personnel are current, correct, and complete
  • Work with Manufacturing Systems Coordinator to track and report on training outcomes
  • Lead all manufacturing and process development aspects of a design from concept to mass production
  • Collect and analyse data
  • Support maintenance of the knowledge and the history of the product process throughout the entire commercial lifecycle
  • Track CPV/AMB parameters provided by the CMOs
  • Performs repair and maintenance associated with manufacturing and assembly
  • Troubleshoots problems in non-functioning equipment
Qualifications for manufacturing technical
  • Enterprise solutions selling experience is desired
  • Understanding and experience with automated processes
  • Strong computer skills in a variety of software packages (Excel, JMP)
  • 3+ years of work experience in engineering, manufacturing, program management and new product introduction in a high volume manufacturing environment is required
  • Knowledge of programming in environments such as LabVIEW, C/C++ and knowledge of PLC programming
  • Ability to take initiative to start and complete tasks independently or in a team environment are essential
3

Manufacturing Technical Job Description

Job Description Example
Our innovative and growing company is hiring for a manufacturing technical. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manufacturing technical
  • Create an environment that encourages teamwork, employee participation, and continuous improvement to ensure equipment reliability through an effective maintenance process
  • Receive request for quotes from customers and partner with operations team to initiate estimates
  • Review purchase orders from customers, enter orders, communicate order acknowledgements to the customer (including any changes in terms, conditions, and shipment information)
  • Utilize shop floor scheduling system to accurately project lead-times and delivery dates
  • Partner with operations to ensure orders are planned and prioritized and late shipments are minimized
  • Communicate routinely with customers regarding their ship dates and order status
  • Visit customers to promote Martinsville INVISTA capabilities, develop and improve revenue opportunities for materials and services
  • Collaborate with the customer to understand quality and yield issues and report issues to the operations team to drive partnerships for value creation, innovations, and improvements for INVISTA sites
  • Partner with operations to ensure raw materials are available to meet customer and business needs, interface with raw material suppliers to manage inventory levels and communicate INVISTA forecasts
  • Contact customers to project future orders, review customer sales, and provide a report to operations for production planning
Qualifications for manufacturing technical
  • Strong understanding and appreciation for regulatory requirements and compliance standards
  • Must have experience working in regulated Life Science environment
  • Have a deep understanding of cell culture / purification processes and possess effective troubleshooting skills with equipment and/or manufacturing process
  • Strong ability to multitask and work independently or in a team environment with minimum supervision
  • Strong ability to teach others and assess understanding of topics by trainees
  • Demonstrate consistently good verbal and written communication and interpersonal skills with employees, management, regulatory inspectors, and clients (where applicable)
4

Manufacturing Technical Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of manufacturing technical. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for manufacturing technical
  • Documenting workflows and results of business analysis and obtaining sign-off from users on specifications
  • Build sustainable customer relationships
  • Partner with operations to ensure customer focus exceeds customer expectations for quality, service, and on-time delivery
  • Ensure that objective and timely feedback is provided to employees
  • Produces manufacturing procedures, graphics
  • Participates in the preparation of proposals and submissions of the Company by suggesting methods, techniques, standards
  • Review changes to manufacturing processes, raw material sources, manufacturing equipment, and evaluate technical requirements to implement change
  • Lead the development of the annual business plan and major forecast updates with Global Leadership Team
  • The Analyst will ensure timely and accurate quarterly financial closing/reporting, submission of results and reviews with Functional Leadership
  • He/she will analyze performance versus financial plans/commitments and drive analytics and insights on financial results
Qualifications for manufacturing technical
  • Configuration Management and Data Management Experience
  • Existing Confidential Security Clearance
  • Generally requires a PhD or Msc
  • BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 5+ years of experience
  • Cell culture and/or aseptic processing experience
  • Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus
5

Manufacturing Technical Job Description

Job Description Example
Our growing company is looking to fill the role of manufacturing technical. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manufacturing technical
  • Consolidate financial data related to volumes for actuals and forecast cycles
  • Develop consistent analytical tools to drive quality commentary on platform performance
  • Work with the manufacturing site controllers to develop and report platform analytics on an on-going basis to support competitive benchmarking and other analytical tools
  • Help to prepare and present quarterly close commentary and business plan updates
  • Lead the development of consistent processes and metrics across platforms
  • Support Ad-Hoc Requests and Analysis
  • Other activities include identifying and implementing finance process improvements consistent with SDM and ESP and leading sector- level process improvements on an ad hoc basis
  • Ensuring balance sheet is compliant
  • Work closely with their manufacturing sponsor to complete a project with the end goal to maximize efficiency and productivity based on manufacturing needs
  • Document and update operator method sheets, processes, tooling, equipment and product design information
Qualifications for manufacturing technical
  • Completion of 65 credit hours in a machinist field OR mininum of (1) year of machinist experience OR minimum 1 year of experience reading & interpreting blueprints, sketches, procedures and specifications
  • Experience using Microsoft Excel to create and edit spreadsheets
  • Experience using Outlook or another email platform to manage a calendar
  • Able to wear safety glasses, gloves, safety footwear and any other Personal Protective Equipment (PPE) for given tasks
  • Minimum of 2 years of experience working in a machine shop
  • Minimum of 2 years of experience dealing with customers in the machining industry

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