GMP & EHS Compliance Engineer-00000RGK
Description
Crucell is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide.
As GMP & EHS Compliance Engineer you will guide and support the process and analytical development groups and the Pilot Plant GMP crews in critical tasks linked to cGMP and safety (EHS) compliance. You will profit from your experience gained either in a quality or production environment paired with your passion to turn regulations and policies into daily practice. Your ability to partner cross-functionally towards efficient problem solving and to sustain a quality and safety mindset in daily operations will be key for our success!
Main tasks:
1. Primary point of contact for quality and safety tasks and issues within the R&D organization and interface to local R&D quality and EHS team
2. Responsibility for local implementation of quality/safety standards and procedures
3. Maintaining GxP action and self-auditing plans and tracking of quality and safety metrics
4. Establishing and maintaining inspection and audit readiness for the R&D organization
5. Supporting R&D organization in close-out of audit findings, root cause investigations, non-conformances, CAPAs and change controls.
6. Developing and implementing improvement programs and assisting training department and training coordinators in definition and roll-out of tailored class-room and individual trainings
7. Providing Key User support in the application of quality relevant IT systems (Trackwise, Compliance Wire)
8. Partnering with engineering and safety functions to ensure adequate training and oversight of contractors
9. Driving and sustaining a culture of quality and safety with the R&D organization
Qualifications
- MSc degree in life sciences or pharmaceutical engineering
- First working experience (2 yrs.) in a quality/safety department, preferably within a biotechnological API manufacturing or in a Fill Finish environment
- Strong cGxP background and familiarity with quality systems
- EHS mindset and experience with environmental and safety concepts in pharma business
- Strong teaming and communication capabilities
- Troubleshoot and problem solving experience
- Business fluent in English and good language skills in either German or French
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. We look forward to receiving your application.
Primary Location:Europe/Middle East/Africa-Switzerland-Berne-Bern
Organization: Crucell Switzerland AG (8851)
Job Function: R&D Engineering (R&D)
Description
Crucell is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide.
As GMP & EHS Compliance Engineer you will guide and support the process and analytical development groups and the Pilot Plant GMP crews in critical tasks linked to cGMP and safety (EHS) compliance. You will profit from your experience gained either in a quality or production environment paired with your passion to turn regulations and policies into daily practice. Your ability to partner cross-functionally towards efficient problem solving and to sustain a quality and safety mindset in daily operations will be key for our success!
Main tasks:
1. Primary point of contact for quality and safety tasks and issues within the R&D organization and interface to local R&D quality and EHS team
2. Responsibility for local implementation of quality/safety standards and procedures
3. Maintaining GxP action and self-auditing plans and tracking of quality and safety metrics
4. Establishing and maintaining inspection and audit readiness for the R&D organization
5. Supporting R&D organization in close-out of audit findings, root cause investigations, non-conformances, CAPAs and change controls.
6. Developing and implementing improvement programs and assisting training department and training coordinators in definition and roll-out of tailored class-room and individual trainings
7. Providing Key User support in the application of quality relevant IT systems (Trackwise, Compliance Wire)
8. Partnering with engineering and safety functions to ensure adequate training and oversight of contractors
9. Driving and sustaining a culture of quality and safety with the R&D organization
Qualifications
- MSc degree in life sciences or pharmaceutical engineering
- First working experience (2 yrs.) in a quality/safety department, preferably within a biotechnological API manufacturing or in a Fill Finish environment
- Strong cGxP background and familiarity with quality systems
- EHS mindset and experience with environmental and safety concepts in pharma business
- Strong teaming and communication capabilities
- Troubleshoot and problem solving experience
- Business fluent in English and good language skills in either German or French
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. We look forward to receiving your application.
Primary Location:Europe/Middle East/Africa-Switzerland-Berne-Bern
Organization: Crucell Switzerland AG (8851)
Job Function: R&D Engineering (R&D)