Specialist Manufacturing Job Description
Specialist manufacturing
provides technical support for General Manufacturing Practices (GMP) execution of processes, deviation investigations, Corrective Action Prevention Plans (CAPAs), and change controls.
Specialist Manufacturing Duties & Responsibilities
To write an effective specialist manufacturing job description, begin by listing detailed duties, responsibilities and expectations. We have included specialist manufacturing job description templates that you can modify and use.
Sample responsibilities for this position include:
Champion the principles and practices of GMP/GLP
Support establishment of process monitoring parameters and control limits
Understand Mfg
Support QMS and other regulatory activities
Works collaboratively, organizes and drives various improvement initiatives for Manufacturing’s training
Facilitates cross-functional teams to achieve consistent training across functional areas and sites globally
Creates the training content and plan for new employees
Identify and collaborate with SMEs to address training needs
Facilitates meetings with Technical Training Department representative to ensure content aligns with current expectations
Provides employees, management, and regulatory agencies the necessary information regarding employee training
Specialist Manufacturing Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Specialist Manufacturing
List any licenses or certifications required by the position: CPIM, OSHA, PMI, APICS, IPC, HEPA, ITIL, CSCP, CPM, LSS
Education for Specialist Manufacturing
Typically a job would require a certain level of education.
Employers hiring for the specialist manufacturing 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 Specialist Manufacturing
Desired skills for specialist manufacturing include:
Control charting
Corrective actions
CGMP systems and experience with leading investigations
Owning change controls
Writing deviation reports
FDA and European regulations
GMP
Project management
P2P processes
SAP system
Desired experience for specialist manufacturing includes:
1-3 years experience in Pharmaceutic/biotechnology industry
Minitab statistical software
Relevant experience and a particular skill set in their area of expertise that adds value to the business
Four years previous experience in a pharmaceutical environment
Technical University or College diploma/degree in Electrical / Electronics/ Instrumentation / Controls / Mechanical engineering with a minimum of 3 years’ experience in Mfg
Ability to lead the development of manufacturing projects as part of a multidisciplinary team
Specialist Manufacturing Examples
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Specialist Manufacturing Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of specialist manufacturing. 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 specialist manufacturing
- Work with cross-functional teams including New Product Introduction, and New Technology Introduction Engineering and Manufacturing
- Learn new manufacturing processes such as ceramic processing
- Support selection and operation of next generation manufacturing equipment and processes
- Troubleshoot and diagnose a variety of process issues through development activities
- Assist in the investigation, documentation and correction of process/production issues
- Represents Manufacturing operations in change control and deviation meetings
- In conjunction with various internal and external stakeholders, coordinates the resolution of deviations/investigations
- Devises and implements CAPAs to ensure effectiveness
- Actively participates in the identification and implementation of manufacturing procedure improvements intended to optimize existing or new processes and ensure achievement of regulatory and safety requirements
- Reports findings to management team and team members with recommendations for improvement
Qualifications for specialist manufacturing
- Participation in multi-disciplinary teams that focuses in process, product or packing optimization/ continuous improvement
- Experience or exposure to different environments
- Must have excellent oral and written communication skills, and the ability to analyze, evaluate and develop solutions to technical problems
- Requires in depth working knowledge of manufacturing engineering concepts and principles
- Previous work experience in an FDA or ISO regulated environment
- FDA compliant manufacturing experience
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Specialist Manufacturing Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of specialist manufacturing. 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 specialist manufacturing
- Preparing course objectives and outlines
- Monitoring of department training compliance and reporting to management
- Dismantles, adjusts, repairs and assembles equipment according to plans, blueprints, operating or repair manuals, and/or rough sketches or drawings
- May perform equipment modification as directed by test/manufacturing engineers
- Thorough understanding of the general/technical aspects of the job
- Provide support to the Manufacturing area with consideration for the goals and objectives of the area
- Tracks and maintains melt supplies
- Troubleshoots problems with outside suppliers
- Create moderately complex reports, charts and graphs as instructed by Production Manager
- Participates in project teams and provides problem solving expertise as required
Qualifications for specialist manufacturing
- Strong knowledge of word processing, spreadsheet, presentation and database management
- Bachelors’ Degree with > 2 years of related professional experience
- Understands manufacturing processes, knowledge of aseptic processing desired
- Knowledge of ERP systems implementation is desirable
- Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project is required
- Requires a Bachelors’ Degree in a science or engineering discipline
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Specialist Manufacturing Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of specialist manufacturing. 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 specialist manufacturing
- Performs QC testing and evaluates the data of manufactured products according to SOP
- Maintains all instrumentation in satisfactory working order by following scheduled preventive maintenance schedules
- Performs tissue culture in support of manufacturing needs
- Identifies problems and refers them to the Manager
- Orders all reagents and supplies necessary to manufacturing department
- Participates in the improvement of existing procedures and policies
- Disposes of tested reagents or materials according to Manager’s instructions
- Test troubleshooting of products manufactured at our factories
- Responsible to complete all training on time
- Work with Manufacturing supervisors and managers to ensure cGMP compliance with respect to training of manufacturing staff
Qualifications for specialist manufacturing
- Requires a minimum of four (4) years of relevant Fill/Finish experience or closely-related equivalent
- Must have experience working in various Quality Systems, understanding of facility technology, system troubleshooting, CAPA’s and change controls
- Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting
- Attendance / Schedule - The schedule is dependent on the shift hired
- Previous experience with SAP and/or Trackwise preferable
- Familiar with self-directed team concept, operations applications and systems, six sigma, lean manufacturing principles and process improvement tools
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Specialist Manufacturing Job Description
Job Description Example
Our company is hiring for a specialist manufacturing. 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 specialist manufacturing
- Prepare standard operating procedures for new equipment and processes
- Troubleshoot moderately complex production equipment
- Responsible for equipment coordination
- Ability to use software
- Setup, operate, clean, and maintain a variety of complex equipment, which may include standing for periods of over two hours at a time, used in the preparation of various pharmaceutical dosage forms in accordance with prepared formulas and standard operating procedures
- Enter data in project batch records and gather other data as needed to complete related reports
- Assist with the disposal of unused components, unused finished products, and unused rejected products
- Assist with packaging of product for shipping and preparation of all necessary documentation as directed
- Assist with the preparation of master batch records
- Assist with the preparation of product specifications
Qualifications for specialist manufacturing
- Bachelor’s degree in molecular biology, chemistry or equivalent with minimum 5 years of experience in biotech industry
- Ability to handle repetitive hand motions with good manual dexterity
- Must be detail-oriented with ability to retain and apply knowledge
- Familiarity with SAP and Agile would be a plus
- Have a deep understanding of purification/cell culture processes and possess effective troubleshooting skills with equipment and/or manufacturing process
- Responsible for scheduling and updating training assignments to ensure site maintains training compliance for standard operating procedures, work instructions and related documents
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Specialist Manufacturing Job Description
Job Description Example
Our company is looking for a specialist manufacturing. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for specialist manufacturing
- Processing of Material Incidents, including those effecting multiple facilities
- 2-6 years of relevant experience in Pharmaceutical Manufacturing or Quality Control or Quality Assurance
- Completes appropriate training documentation
- Follow regulations and procedures for handling hazardous/regulated chemicals
- Prepare or revise standard operating procedures for new or existing equipment and processes
- Transfers lean knowledge to others and leads others during implementation of projects to achieve a Lean Enterprise
- Acts as a change agent leading continuous process improvement and product or process development
- Conduct classroom style training session for all operations personnel, in various production functions
- Work with technical leads and managers to create effective user-focused work instructions, and other training materials as needed to support manufacturing training efforts
- Produce training materials for in-house courses as appropriate
Qualifications for specialist manufacturing
- Demonstrated ability to be organized and lead in small work groups
- Must be able to perform computer operations such as MS Office and Outlook and other computer based software
- Guide and assist pharmaceutical operators in the efficient and proper operation of equipment
- Perform and/or assist reconciliation of batch paperwork if necessary
- Maintain proper personal hygiene as required by cGMP’s
- Perform other related duties as required by the job or directed by the supervisor