CSV Engineer - Pharma/biotech
Posted on Jan 8, 2020 by Experis AG
Biotech - CSV Engineer
Experis is currently supporting our globally-operating client within the biotech industry with their search for an experienced CSV Engineer to support their operations at their manufacturing facility in the Solothurn region. This contract role will run a minimum of 6 months (+extension is highly likely).
- Lead validation activities of Computerized Systems for our end-customer
- Assist in maintaining equipment automation systems in a validated state as they relate to GxP CSV automation systems.
- Execute QA reviews and approvals of IT SOPs, and validate master plans for computerized system implementations.
- Develop an appropriate document control capability and ensure all documents filings and archiving systems are accurate, up to date and maintained in accordance with GMP and other relevant regulations.
- Establish and ensure good and close working relationship with important project stakeholders and internal customers.
- You must hold either a Swiss or an EU passport to be considered for this position
- MSc Degree in engineering, IT, Science or Computer related discipline.
- 5 years proven track record in Computer System Validation within pharma/biotech
- Strong project management skills with the ability to prioritize assignments
- Familiar with GxP systems.
- Fluent knowledge of GAMP 5, Annex 11, CFR Part 11 Compliance and CFR Part 210, 211 & 820 compliance.
- Languages: English (+German if possible!)
If you are immediately available for this exciting project in Zug, Switzerland, please get in touch directly with Eric Schuster or send him your CV and testimonials today through the link in the advert. We can only consider Swiss/EU nationals for this engagement.
Experis is Europe's leading IT&T recruitment agency.