We are currently looking for a Process Manager that will be responsible for the smooth and GMP-compliant operation of production facilities, focusing on stabilizing and continuously improving processes and adjacent facilities. This role requires a deep understanding of operational processes and facilities, along with excellent organizational skills for project management.
Key Responsibilities:
1. Manage deviations and complaints as the deviation owner.
2. Support production lines with compliance issues.
3. Create and maintain GMP documents in line with regulations.
4. Handle changes as the change owner.
5. Lead and implement root cause analysis (RCA).
6. Regularly review key performance indicators and implement improvements or corrections.
7. Implement or support system tests and validations.
8. Serve as the operational contact for processes and systems.
9. Collaborate on the introduction of development products and transfer projects.
10. Write recipes for the process control system (PCS).
11. Plan and implement APS (Aseptic Process Simulation) and service life validations.
12. Monitor processes.
13. Assist in creating and testing recipes and manufacturing instructions.
14. Represent the area as a subject matter expert (SME) during inspections and audits.
15. Handle multi-site assessments.
16. Conduct training within the process unit.
17. Ensure compliance with safety and environmental regulations.
18. Conduct SGU Gembas to support and promote operational safety, including defining measures and actions.
19. Utilize LPS tools.
Requirements:
1. Completed technical training (e.g., technician, fitter, mechatronics engineer, electrician, mechanic) with several years of experience in a GMP-regulated manufacturing environment, or
2. A degree in life sciences or engineering (e.g., process engineering, pharmaceutical technology) with initial professional experience in a GMP-regulated manufacturing environment.
3. Strong knowledge of operational processes and systems.
4. Initial experience in change and deviation management, including CAPAs.
5. Proficiency in German and good knowledge of English.
Location: Kaiseraugst
Start Date: March 2025
Duration: 12 months.
If you are interested, apply directly or send me your CV at mbertrand@actalentservices.com.
Job Title: Process Manager
Location: Kaiseraugst, Switzerland
Job Type: Contract
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