PCS 7 Validation Engineer
Katalyst HealthCares & Life Sciences
- Woodinville, WA
- Permanent
- Full-time
We are seeking a highly skilled and detail-oriented PCS 7 Validation Engineer to join our Automation/Validation team. This role will focus on developing and maintaining validation documentation for Siemens PCS 7 control systems within a regulated GxP environment. Your expertise will ensure compliance with FDA, EU, and GAMP 5 standards while supporting system readiness for production. Although primarily a documentation-focused position, you may also provide on-site execution support.
Responsibilities:
- Develop, write, and maintain standardized CSV templates and test protocols for Siemens PCS 7 systems.
- Collaborate with cross-functional teams (Automation, Manufacturing, Quality, Engineering) to define system functionality and testing requirements.
- Ensure validation documentation aligns with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and internal SOPs.
- Support execution of validation protocols (equipment setup, test witnessing, documentation, troubleshooting).
- Document and assist in investigating deviations/non-conformances.
- Generate summary reports on validation activities.
- 3+ years of experience in validation within a GxP regulated industry (Pharma, Biopharma, Medical Device, etc.).
- Hands-on experience with Siemens PCS 7 architecture and components (OS, BATCH, Historian, etc.).
- Strong background in drafting/authoring validation documents (IQ/OQ/PQ) for process control systems.
- Solid knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Excellent technical writing and communication skills with attention to detail.
- Ability to work independently in a fast-paced project environment.