Position Summary
We are seeking a Validation Engineering Manager to lead a team of validation engineers supporting manufacturing processes, equipment, and systems in a regulated CBR environment — including blood bank, gene therapy, biologics, and vaccine operations. This individual will set validation strategy, ensure compliance with FDA and cGMP standards, and partner cross-functionally with Quality, Manufacturing, and R&D.
Key Responsibilities
- Manage, mentor, and develop a team of validation engineers
- Set team priorities, allocate resources, and ensure projects are completed on schedule
- Define and drive validation strategy for processes, equipment, utilities, and systems
- Oversee authoring and execution of validation documentation (URS, IQ, OQ, PQ, Validation Summary Reports)
- Maintain the Master Validation Plan and lead change control activities
- Review and approve validation protocols and reports; present findings to leadership
- Ensure compliance with FDA regulations and cGMP; lead regulatory inspections and audits
Qualifications
- Bachelor's degree in Engineering or related technical field
- 10+ years of validation experience in a regulated industry; 3+ years in a management or team lead role
- Direct experience in one or more CBR disciplines: blood bank, gene therapy, biologics, or vaccine
- Strong experience with process validation and equipment qualification
- Knowledge of FDA regulations and cGMP
Preferred
- Experience across multiple CBR disciplines
- Sterilization validation
- Microbiological / microvalidation experience