CSV Engineer (German speaker)
Temporary contract
Start date : ASAP, End date : 31.12.2024
Location: Bern, Switzerland
Company Description:
Our client is a leading biotechnology company specializing in vaccines and biopharmaceutical technologies. Their site in Bern focuses on viral and bacterial vaccines for clinical development phases, collaborating closely with their sister company in the Netherlands.
Job Description:
As a CSV Engineer, you will be responsible for Computer System Validation activities for their Technical Services department to ensure compliance with global and local company policies, as well as legal and regulatory requirements.
Responsibilities:
- Lead CSV activities for assigned projects, ensuring validation phases are performed according to company procedures and regulatory standards.
- Plan, coordinate, and execute all phases of computer system validation for production and QC Lab systems.
- Perform CSV periodic reviews of equipment and systems.
- Prepare, review, and approve technical and GMP-related documentation.
- Coordinate FAT/SAT and commissioning activities for new systems.
- Handle Change Controls, CAPAs, and Non-Conformances related to CSV.
- Contribute to ensuring changes in systems and procedures are managed effectively.
Requirements:
- Bachelor's or master's degree in technical or natural sciences.
- Minimum 3 years of working experience within pharma or biotech.
- Minimum 4 years of working experience with CSV.
- Knowledge of FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
- Excellent communication and analytical skills.
- Ability to work independently and as part of a team.
- Fluency in English and German is mandatory (interviews conducted in German)
- Experience with validating manufacturing and analytical equipment is a plus.
This is a full-time position based in Bern, Switzerland. Candidates must be able to commute to Bern regularly. Our client offers a dynamic work environment and opportunities for professional development.
Apply now to join their innovative team!
Address
Randstad (Schweiz) AG
