Summary:
The Validation Lead is responsible for leading end-to-end validation activities within a regulated pharmaceutical, biotechnology, medical device, or life sciences environment. The role develops validation strategies, coordinates cross-functional teams, oversees qualification and validation execution, and ensures compliance with GMP/GxP, FDA requirements, GAMP 5, and data integrity expectations. Typical responsibilities include process, equipment, facility/utilities, cleaning, and/or computerized system validation depending on the program.
Responsibilities:- Lead and coordinate validation activities from planning through final approval.
- Develop and maintain Validation Master Plans (VMPs) and project-specific validation strategies.
- Prepare, review, and approve validation documents including URS, risk assessments, DQ, IQ, OQ, PQ, traceability matrices, protocols, and validation summary reports.
- Lead process, equipment, cleaning, facility/utilities, and/or computerized system validation activities as applicable.
- Coordinate validation execution with Quality, Engineering, Manufacturing, Automation, IT, Laboratory, and external vendors.
- Manage deviations, discrepancies, CAPAs, and change controls associated with validation activities.
- Ensure validation deliverables meet project timelines and regulatory requirements.
- Provide technical leadership for validation investigations and complex validation challenges.
- Monitor validation metrics, project progress, risks, and issues.
- Support audits, regulatory inspections, inspection readiness, product launches, and technical transfers.
- Provide technical guidance and mentoring to validation engineers and specialists.
- Identify opportunities to improve validation processes, documentation, and execution efficiency.
Requirements:- Bachelor's degree in Engineering, Chemistry, Pharmacy, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related technical discipline.
- Typically 5+ years of validation experience, with lead-level roles often requiring substantially more experience depending on scope.
- Strong experience in a GMP/GxP-regulated pharmaceutical, biotech, medical device, or life sciences environment.
- Hands-on knowledge of the validation lifecycle, including URS, risk assessment, IQ/OQ/PQ, traceability, and validation reports.
- Strong knowledge of FDA regulations, cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles where applicable.
- Experience leading cross-functional validation projects and managing multiple priorities.
- Strong technical writing, documentation, communication, and stakeholder-management skills.
- Experience with deviations, CAPA, change control, and quality systems.
- Ability to support audits and regulatory inspections.
- Strong analytical, troubleshooting, organizational, and problem-solving skills.
- Experience with validation management/documentation tools such as Kneat, ValGenesis, TrackWise, Veeva, or similar platforms is beneficial.