Quality engineer; Sr level

Quality Engineer (Sr Level)

Remote QMS support across quality groups

1. Apply extensive knowledge of technical and validation standards/requirements and industry guidance to influence the interpretation of governing requirements as it related to quality systems and validation

2. Understand JEB equipment management program to ensure manufacturing equipment is in state of control, including reviewing and approving equipment calibration and preventive maintenance documents

3. Provide quality oversight of the installation, qualification/validation, operation and maintenance of GMP equipment, facilities, utilities and computerized systems including infrastructure qualification

4. Review and approve qualification/validation documents, before and after execution as required

5. Support process transfer from development to commercial drug substance manufacturing

6. Mentor functional groups in qualification/validation technical aspects, and compliance requirements

7. Partner with the biologics manufacturing sites on the implementation of new manufacturing and quality systems/equipments

8. Apply quality risk management principles to situations as the need arise

9. Works collaboratively with both internal/external collaborators, vendors and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance

10. Apply knowledge of GMP computerized systems, qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industrial standards

11. Perform SDLC validation planning for each computerized system to ensure complete, successful end-to-end qualification of electronic systems including system interfaces and infrastructure usage

12. Provide oversight to the overall site validation master plan, including interactions with other Just-Evotec entities responsible for related non-site-based computer systems