Description:
As a Senior CSV Engineer, you will lead the development, review, and execution of automation-related validation documentation and activities. You’ll collaborate closely with cross-functional SMEs, equipment vendors, and quality teams to ensure compliance with regulatory standards and project timelines.
Your responsibilities will include:
- Leading the authoring and management of key validation documents: C&Q Plans, PCS Automation Validation Plans, URS, FAT, IOQ, Summary Reports.
- Overseeing and supporting FAT and IOQ execution, ensuring alignment with test scripts and resolving protocol execution issues.
- Executing CSV-related tests on equipment and production lines.
- Ensuring compliance with 21 CFR Part 11, EudraLex Annex 11, and GAMP 5.
- Maintaining traceability across all validation documentation (URS, FAT, SAT, IOQ, RTM, etc.).
- Identifying risks and recommending improvements to validation strategies and documentation quality.
- Sharing lessons learned and contributing to continuous improvement for future projects.
Requirements:
- Degree in Computer Science, Engineering, or a related discipline.
- Minimum 5 years’ experience in a similar role within the life sciences sector, ideally in pharmaceutical manufacturing.
- Essential understanding around Emerson DeltaV
- Strong understanding of computer systems and PLC automation systems.
- Proven experience authoring and executing FAT and IOQ protocols.
- Familiarity with GMP environments and validation processes aligned with EU and FDA regulations.
- Expertise in GAMP 5 and SDLC documentation (URS, FS, DS, RTM, etc.).
- Strong problem-solving, communication, and documentation skills.
- Experience with paperless validation systems (e.g., Kneat) is a plus.
- Ability to collaborate with QA, vendors, and cross-functional teams to ensure project success.