TheStaffed
We are seeking
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.
Requirements and Qualifications : • Act as a bridge between business stakeholders, product managers, and engineering teams 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, 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. • Ability to work independently in a fast-paced project environment.
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.
Requirements and Qualifications : • Act as a bridge between business stakeholders, product managers, and engineering teams 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, 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. • Ability to work independently in a fast-paced project environment.