GMP Validation Engineer
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APPLY
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Scope of Function:
Planning and executing validation, calibration and preventive maintenance of analytical and process equipment according to cGMP guidelines for manufacturing biologics. Responsible for following cGMP documentation practices. Work with QA Department to ensure compliance with Validation Master Plan and GMP guidelines. Provide engineering assistance and participate in emergency repairs as a member of Emergency Response Team as required. Work closely with the Director of Facilities and Director of QA/QC as a part of GMP compliance team.
Reports to: Facilities Director
Specific Duties:
Planning and executing validation, calibration and preventive maintenance of analytical and process equipment according to cGMP guidelines for manufacturing biologics. Responsible for following cGMP documentation practices. Work with QA Department to ensure compliance with Validation Master Plan and GMP guidelines. Provide engineering assistance and participate in emergency repairs as a member of Emergency Response Team as required. Work closely with the Director of Facilities and Director of QA/QC as a part of GMP compliance team.
Reports to: Facilities Director
Specific Duties:
- Planning and executing qualification, calibration and preventative maintenance on GMP analytical and process equipment
- Generate and review qualification protocols and summary reports for qualification activities executed by outside vendors
- Responsible for working with QA to determine qualification, calibration and PM requirements for laboratory and process equipment, and execute schedule activities to comply with GMP regulations
- Generate and review calibration and preventative maintenance documentation
- Administrate calibration/preventative maintenance/qualification database
- Function as a member of emergency response team to address any emergency due to equipment, facility, operating system malfunction, or any other company needs
- Provide engineering support for:
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- Responsible for facility and equipment related GMP documentation including CAPAs, Deviations and Investigation Reports
- Work with vendors and contractors to ensure that maintenance activities are executed under GMP/FDA regulations
- Assist Facilities Department in the execution of engineer projects, technical drawings, renovation and upgrade projects, etc.
- Ability to lift up to 50 pounds
Education and Experience Required:
Education:
- BS in Engineering
- 5 years of experience in GMP Pharmaceutical/Biotech environment, Mechanical and Good Documentation Skills
- Manufacturing
- Process Development
- Quality Assurance
- Quality Control
- Outside contractors and government agencies
