Automation/CSV Engineer
About the Role
We are seeking an experienced Automation & Computer System Validation (CSV) Engineer to support a major pharmaceutical capital project. This role is critical to ensuring compliance, integration, and validation of automated systems during the execution phase.
Key Responsibilities
- Execute CSV activities including IQ/OQ for automated systems.
- Support vendor FATs/SATs and troubleshoot technical issues.
- Ensure GMP compliance and adherence to regulatory standards.
- Work with OEM systems (e.g., autoclaves, parts washers) and ensure proper integration.
- Collaborate with vendors and internal teams to meet project timelines.
- Prepare and maintain validation documentation in line with GAMP5 and company standards.
Requirements
- 5-10 years' experience in Automation and CSV within pharmaceutical or biotech projects.
- Strong knowledge of GMP regulations and validation protocols.
- Hands-on experience with OEM equipment and automation platforms.
- Familiarity with PSC7 and network integration concepts.
- Excellent problem-solving and communication skills.
- Ability to work independently on-site in Germany.
Nice to Have
- Experience with vendor management and FAT/SAT execution.
- Knowledge of GAMP5 guidelines and industry best practices.
- German language skills (preferred but not mandatory).
FAQs
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