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