Description
Contract Computer Systems Validation EngineerBerlin
€65 per hour
12 months
Optimus Life Sciences is working with a large Pharmaceutical company, who thanks to recent expansion, are looking to bring in a Computer Systems Validation (CSV) Engineer to join their team on site in a contract role.
The role has strong possibilities for extension and requires applicants to be a minimum of C2 level German (written & spoken).
Responsibilities
- Provide CQV MES technical support for multiple pharma manufacturing sites worldwide.
- Keep systems and processes developed for computer and automation systems validation up to date and compliant.
- Optimization of CQV support process, including developing standards and KPI reports.
- Ensure standardization and efficiencies across multiple projects.
- Compile and analyse validation data and make recommendations for changes and/or improvements.
- Maintain all documentation pertaining to computer systems validation.
- Participate on cross-functional project teams including development & deployment teams as well as customer Manufacturing, Engineering, Quality and other groups.
- Working in a remote team environment (e.g. team members being in geographically dispersed locations).
Requirements
- Minimum of a bachelor's degree with a minimum of 3+ years of related CSV industry experience (Pharma/Biotech).
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11.
- Strong knowledge of computerized system development life cycle approach is required.
- The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
- Ability to work well as part of a team and independently.
- Excellent PC skills with proficiency in either MES or automation systems.
- Strong German and English written and verbal communication skills are required.
If you're interested in applying for this role, please send a CV to for more detail - thanks!