Validation Specialist

My client is looking for a Senior Validation Engineer to support process validation and equipment/utility qualification activities within a regulated manufacturing environment. The role will focus on planning and executing validation studies, authoring and running protocols, supporting sampling activities, and ensuring all work is performed in line with applicable cGMP and regulatory expectations.

• Develop and execute validation strategies aligned with internal procedures and regulatory expectations
• Lead or support process validation lifecycle activities, including PPQ protocol development, execution, sampling coordination, and reporting
• Perform and document commissioning, qualification, and requalification for manufacturing equipment and facility/utility systems
• Conduct risk assessments and gap assessments (e.g., to support changes, deviations, and periodic reviews), and contribute to lifecycle management activities
• Ensure validation documentation is accurate, traceable, and inspection-ready, maintaining equipment master data where required
• Support the creation and revision of SOPs, protocols, reports, and other controlled documents in line with site quality systems
• Collaborate cross-functionally with Manufacturing, QA, Engineering, and QC to drive compliant execution and timely closeout of validation deliverables

• 3+ years’ experience in Validation Engineering and/or Process Engineering within a regulated environment
• Strong background in Process Validation, including PPQ planning and execution
• Hands‑on Commissioning & Qualification (C&Q) experience covering equipment, utilities, and facility systems
• Proven ability to author, execute, and close out IQ/OQ/PQ protocols and reports
• Working knowledge of FDA/EMA cGMP requirements and ICH Q7–Q10 (or equivalent regulatory standards)
• Strong documentation skills with an audit‑ready mindset

Looking forward to speaking with you!