PCS 7 Validation Engineer
New Yesterday
Job Description:
We are seeking a highly skilled and detail-oriented PCS Validation Engineer to join our Automation/Validation team. This role will focus on developing and maintaining validation documentation for Siemens PCS control systems within a regulated GxP environment. Your expertise will ensure compliance with FDA, EU, and GAMP 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 systems.
Collaborate with cross-functional teams (Automation, Manufacturing, Quality, Engineering) to define system functionality and testing requirements.
Ensure validation documentation aligns with GAMP , FDA CFR Part , EU Annex , 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.
Requirements: + years of experience in validation within a GxP regulated industry (Pharma, Biopharma, Medical Device, etc.).
Hands-on experience with Siemens PCS 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 CFR Part , EU Annex , and GAMP .
Excellent technical writing and communication skills with attention to detail.
Ability to work independently in a fast-paced project environment.
- Location:
- Woodinville