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).