PCS 7 Validation EngineerKatalyst Healthcares and Life Sciences • Woodinville, WA, United States

PCS 7 Validation Engineer

Katalyst Healthcares and Life Sciences • Woodinville, WA, United States

1 day ago

Job type

Full-time

Job description

Job Description :

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.
lthough primarily a documentation-focused position, you may also provide on-site execution support.

Key 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.

Required Qualifications :

3+ years of experience in validation within a GxP regulated industry (Pharma, Bio-Pharma, 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.

bility to work independently in a fast-paced project environment.

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Validation Engineer • Woodinville, WA, United States

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