Manufacturing Specialist Job Description

Manufacturing Specialist Job Description

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Manufacturing specialist provides guidance to physicians, manufacturing team, CPRMC, PRMC, DSMC and IRB in the interpretation of GXPs, IRB, and, ICH, and FDA regulations and guidelines.

Manufacturing Specialist Duties & Responsibilities

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

Sample responsibilities for this position include:

Ensure that all production batch procedural documentation, such as project change controls, change notices, risk assessment reports, process validation protocols and reports, new batch manufacturing records, and SAP BOMs, recipes and PI sheets, are current, accurate, and clearly define process and role responsibilities and that they are in place prior to the technical transfer of the process to manufacturing
Orders and stocks parts, supplies, measuring tools and hand tools
Provide support for Manufacturing department regarding training issues and questions
Supports the introduction of new product introduction activities and ensures procedural requirements are met
Leads team to complete assessments on time, determine deliverables prior to introduction, and own the over-arching change control
Thoroughly investigates deviation events utilizing root cause analysis techniques
Inspection Preparation and Readiness
Execute structured experiments to develop robust process parameters
Support Low Rate Initial Production of development programs
Perform assigned tasks including setup, installation, calibration, documentation and operation of advanced manufacturing equipment

Manufacturing Specialist Qualifications

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

Licensing or Certifications for Manufacturing Specialist

List any licenses or certifications required by the position: CPIM, OSHA, PMI, APICS, IPC, HEPA, ITIL, CSCP, CPM, LSS

Education for Manufacturing Specialist

Typically a job would require a certain level of education.

Employers hiring for the manufacturing specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Manufacturing, Engineering, Technical, Science, Chemistry, Education, Biotechnology, Chemical Engineering, Manufacturing Engineering, Life Sciences

Skills for Manufacturing Specialist

Desired skills for manufacturing specialist include:

Familiarity with ICH guidelines and EU regulations
FDA regulations
Regulatory compliance inclusive of cGMP
Tooling
SAP
Blue-prints
Gauging equipment and use of proper handling methods in assigned areas
Measuring
Operations and lean manufacturing tools and principles
Proper set-ups for machinery

Desired experience for manufacturing specialist includes:

This position may require shift rotations and extended work hours
High School Diploma/GED with 10 or more years of experience with equipment maintenance in a manufacturing environment or Associate’s degree in Electrical, Instrumentation, Mechanical or Mechatronics or related fields with 5-8 years experience with equipment maintenance in a manufacturing environment
Ability to lift, push, pull, or move up to 60 lbs
Proficient in the use of a PC to troubleshoot equipment
Proficient in MS Excel & Word applications
Previous work experience with Allen-Bradley Programmable Logic Controllers (PLCs) and making modifications to Ladder Logic

Manufacturing Specialist Examples

1

Manufacturing Specialist Job Description

Job Description Example
Our company is looking for a manufacturing specialist. 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 specialist
  • Develop and implement any overarching initiatives
  • Complete and obtain approval for purchase requisitions
  • Follow all established lab procedures
  • Formulate, develop, and implement a consistent training program for new hire training, on-the-job training and compliance in conjunction with manufacturing requirements
  • Ensure requirements and documentation meet business and regulatory requirements
  • Define measures of effectiveness for appropriate trainings
  • Integrate training plans with Learning Management System
  • Assist in developing and maintaining training metrics to drive performance improvements
  • Training/teaching new and existing personnel in hands-on techniques associated with large-scale manufacturing procedures and identify, coordinate and train trainers to assist with the training function
  • Identifying areas for training and developing educational items including online modules, workshops, instructional videos, and one-on-one training sessions
Qualifications for manufacturing specialist
  • Broad technical knowledge of cGMP systems and experience with leading investigations, writing deviation reports, owning change controls, and corrective actions
  • Understands manufacturing processes
  • Experience performing basic bacterial testing
  • Machine tool programming experience
  • Bachelors’ Degree in life sciences with more than 10 years of related professional experience
  • Experience in Quality Assurance is desired
2

Manufacturing Specialist Job Description

Job Description Example
Our innovative and growing company is hiring for a manufacturing specialist. 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 specialist
  • Corrects work center performance issues after they are identified
  • Maintain advanced knowledge of the existing manufacturing systems including the computer systems, steel making processes, material flow and handling schemes, quality systems and process control techniques while developing knowledge of new systems and processes
  • Creates SOP and FMEA documents as instructed
  • Evaluate new equipment, and process and maintenance technologies and provides feedback to management
  • Review manufacturing line-ups for accuracy and recommend changes as necessary
  • Participates in the development of equipment scheduling rates and guidelines
  • Responsible for equipment TPM planning
  • Provides training to process operators
  • Responsible for RMR and SPC analysis
  • Titration of individual componentry used to manufacture reagents
Qualifications for manufacturing specialist
  • Must obtain & maintain qualifications, as required, to perform the assigned work
  • Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
  • Master’s degree in Chemical Engineering or Life Sciences
  • Degree or Diploma in Engineering, Manufacturing or related discipline or equivalent experience
  • Minimum 3 years of pharmaceutical GMP related manufacturing experience
  • Experience in the pharmaceutical or related environment is a must
3

Manufacturing Specialist Job Description

Job Description Example
Our growing company is looking for a manufacturing specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manufacturing specialist
  • Lead training efforts and assist in developing training content as needed
  • CMMS equipment maintenance
  • MFG support
  • Equipment/Process troubleshooting
  • Document procedures according to established regulatory guidelines
  • Completes appropriate training documentation for supervised personnel
  • Follow regulations and procedures for handling and recording raw materials including hazardous/regulated chemicals
  • Follow aseptic technique for the manufacture of sterile products to prevent microbial contamination
  • Clean or prepare manufacturing areas using odorous compounds
  • Participate in equipment validations
Qualifications for manufacturing specialist
  • Bachelor’s degree from an accredited institution, with a minimum of two (2) years’ experience in a GMP Pharmaceutical manufacturing environment
  • Associate's degree from an accredited institution with a minimum of four (4) years’ experience in a GMP Pharmaceutical manufacturing environment
  • The position requires the individual to be able to handle multi tasks and implement solutions to complex problems using the best available technology
  • Contributes to the completion of cross organizational projects and goals
  • Effectiveness of training plans and training delivery affect compliance against GMP and other external regulatory bodies
  • Strong ability to teach others and assess understanding of topics of trainees
4

Manufacturing Specialist Job Description

Job Description Example
Our growing company is looking to fill the role of manufacturing specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manufacturing specialist
  • Acquire new methods according to standard operating procedures of other manufacturing units
  • Contribute to performance metrics for Quality/Compliance related topics, such as Deviations, CAPAs, Effectiveness Checks
  • Contributes to audit/regulatory agency observation responses, including tracking of timelines, status, and completion
  • Supports communication of GxP initiatives
  • TrackWise deviation processing, including global/multi-plant issues
  • Trackwise change control processing, including cross functional changes
  • Works with Quality to facilitate, coordinate, or participate in MFG support for inspections
  • Participates in investigations, including determination of root cause and evaluation, initiation, and ownership of CAPA’s, possibly across campus
  • Maintain and report out metrics for regulatory inspections and audit commitments
  • Participate in impact assessment for SCN (supplier change notifications)
Qualifications for manufacturing specialist
  • Highly regulated (GMP)
  • Perform preventive maintenance including lubrication, fluid level checks, filter replacements, and wear inspection
  • Set-up and challenge Vision systems
  • Set-up filler, labeller, and/or other coding equipment
  • Execute manufacturing recipe and/or Clean-in-Place cycles per batch record and process control systems if applicable
  • Document cleaning, set-up, and operational activities on logbooks, batch records and/or official forms
5

Manufacturing Specialist Job Description

Job Description Example
Our company is growing rapidly and is looking for a manufacturing specialist. 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 specialist
  • Establish consistent documentation practices across operations
  • Ensure that each area has work instructions and training materials completed, and they are reviewed and updated periodically, as needed
  • Identify and assess training needs of operations staff by conferring with managers and supervisors
  • Coordinate, schedule and conduct technical training for new hires and current employees in the operations areas
  • Contact with line managers/supervisors to build up schedule for training materials
  • Helping line managers and OJT trainers to solve specific training problems, either on a one-to-one basis or in groups
  • Coordinate with department OJT trainers to ensure that proper training is occurring and is being recorded appropriately
  • Own and manage Mfg
  • Drive and own improvement projects that support KPI’s, with a focus on cost, innovation, on-time delivery and quality
  • Generate and Manage Metrics
Qualifications for manufacturing specialist
  • Engineering university degree is preferred
  • Very good level of English both written and spoken
  • Organized, structured and result oriented professional with the ability to maintain long term strategic focus
  • Candidate must possess at least a Professional Certificate/NiTEC, Diploma, Advanced/Higher/Graduate Diploma, Engineering (Material Science), Engineering (Mechanical), Engineering (Mechatronic/Electromechanical), Engineering (Metal Fabrication/Tool & Die/Welding) or equivalent
  • Preferably Technicians specializing in Engineering - Mechanical/Automotive, Engineering (Metal Fabrication/Tool & Die/Welding) or equivalent
  • Bachelor’s Degree or Master’s Degree in Chemical Engineering or related technical field

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