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. 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.

Requirements:

• 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.

• 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