Senior Validation Engineer
We’re seeking an experienced Validation professional to independently lead and execute complex validation activities supporting GMP manufacturing operations. This role is ideal for a hands-on, compliance-focused expert who can balance multiple priorities, lead validation efforts with minimal oversight, and partner cross-functionally to support equipment readiness, inspections, and new product launches.
Key Responsibilities
Validation Leadership & Execution
• Independently draft, execute, and close validation plans, protocols, test strategies, and final reports
• Lead qualification activities for equipment, facilities, utilities, and computerized systems
• Serve as Lead Validation representative on project teams supporting changes, deviations, tech transfers, and new product launches
• Ensure validation activities meet GMP, FDA, EU, and internal quality requirements
• Maintain validation areas in a constant state of inspection readiness
Technical & Cross-Functional Support
• Partner with Engineering, Maintenance, Production, and Quality teams on system selection, upgrades, and commissioning
• Develop and review URS, RA, FRS, and DQ documentation
• Support cleaning validation, utilities qualification (HVAC, water, gases), and media fill oversight
• Execute requalification and periodic reviews for autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas
• Perform room qualifications and smoke studies in Grade A pharmaceutical environments
Compliance, Audits & Continuous Improvement
• Support Change Controls, Deviations, and CAPAs, ensuring on-time closure
• Assist with audit responses and regulatory inspections
• Train personnel on validation and quality principles
• Monitor and support completion of required compliance training and KPIs
Required Experience
• 6+ years of GMP validation experience in a regulated manufacturing environment
• (10+ years accepted in lieu of a degree)
• At least 3 years leading validation projects
• Strong experience with:
• Equipment, facilities, utilities, and computer system validation
• Cleaning validation concepts
• Pharma-grade utilities (HVAC, water, gases)
• Ellab data loggers and software
• Extensive technical writing experience with minimal reviewer oversight
• Ability to analyze validation and production data to assess GMP compliance
• Strong leadership, planning, and cross-functional collaboration skills
• Excellent written and verbal communication skills
• Proficiency with MS Word, Excel, Outlook, and PowerPoint
Education
• Bachelor’s degree preferred (Science or Engineering discipline)
Why This Role
• High-visibility validation ownership with real operational impact
• Opportunity to lead complex projects in a regulated biopharmaceutical environment
• Strong cross-functional exposure across Engineering, Production, and Quality
Pharmaceutical Manufacturing
Quality Assurance
Contract