Manufacturing Specialist Job Description
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:
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:
Desired experience for manufacturing specialist includes:
Manufacturing Specialist Examples
Manufacturing Specialist Job Description
- 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
- 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
Manufacturing Specialist Job Description
- 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
- 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
Manufacturing Specialist Job Description
- 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
- 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
Manufacturing Specialist Job Description
- 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)
- 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
Manufacturing Specialist Job Description
- 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
- 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