Progressive Biotech company in Bern (Switzerland), require a dedicated C&Q engineer to start before the end of the year. The role will require you be on-site in SWitzerland within the locality and offers some home working
- Ensure compliance with company policies and regulatory requirements during qualification phases.
- Develop and maintain up-to-date Qualification Master plans for ongoing projects.
- Write, review, and approve Qualification plans, protocols, and final reports for GMP utilities, facilities, and equipment.
- Run DQ, IQ, OQ, PQ protocols, managing deviations and investigations.
- Plan and track C&Q activities/documentation within project timelines.
- Coordinate FAT/SAT and commissioning activities for new GMP systems with internal and external partners.
- Oversee external suppliers and coordinate their activities.
- Bachelor's/Masters degree in Engineering, technical, or natural sciences.
- 5+ years of relevant experience in a similar C&Q/CQV role in the pharmaceutical industry.
- In-depth knowledge of Qualification requirements per cGMP regulations.
- Experience working with cross-departmental stakeholders.
- Familiarity with quality assurance principles.
- Track record of managing multiple projects concurrently in a team environment.
- Proficiency in current GMP standards and guidelines related to equipment, utilities, and facilities qualification (ISO, ICH, FDA, ISPE).
- Business fluency in English; German language skills are a plus.
If interested and available at short notice, please respond ASAP by submitting a resume or reach out to me directly
MSI Group are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.