Validation Engineer

Are you an experienced PCS 7 Validation Engineer with a passion for automation and compliance? This is an exciting opportunity to play a critical role in validating Siemens PCS 7 control systems within a regulated GxP environment. In this role, you will be responsible for creating and maintaining key validation documentation while ensuring that automated processes are compliant with industry standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). While the primary focus is documentation, you may also provide hands-on support during execution of validation activities on-site. What you’ll be doing: Developing and maintaining CSV templates and test protocols for Siemens PCS 7 systems Collaborating with Automation, Manufacturing, Quality, and Engineering teams to define testing requirements Ensuring all documentation meets GAMP 5, SOPs, and regulatory expectations Supporting execution of validation protocols, including setup, witnessing, documentation, and troubleshooting Recording and supporting investigations into deviations and non-conformances Preparing summary reports to capture validation outcomes What we’re looking for: 3+ years of validation experience in a GxP-regulated industry (Pharma, Bio-Pharma, Medical Device, etc.) Strong, hands-on knowledge of Siemens PCS 7 architecture and components (OS, BATCH, Historian, etc.) Solid understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 Exceptional technical writing and communication skills Ability to work independently and manage multiple priorities in a fast-paced environment This is a fantastic opportunity for a motivated validation professional to contribute to critical life science projects while developing their expertise with Siemens PCS 7 in a regulated setting. Seniority level

Seniority level Mid-Senior level Employment type

Employment type Contract Job function

Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Skills Alliance by 2x Sign in to set job alerts for “Validation Engineer” roles.

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