Validation Lead

Katalyst CRO; City of Rochester (NY); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Validation Lead to drive end-to-end validation activities in a regulated life sciences environment in Rochester, NY. You will develop strategies, coordinate cross-functional teams, and oversee URS through PQ to ensure GMP/GxP compliance and data integrity.

Ideal candidates bring 5+ years in validation with hands-on lifecycle experience, strong regulatory knowledge, and excellent technical writing and stakeholder-management skills.

Qualifications

• 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 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.
• Hands-on knowledge of the validation lifecycle, including URS, risk assessment, IQ/OQ/PQ, traceability, and validation reports.
• Experience with deviations, CAPA, change control, and quality systems.
• Ability to support audits and regulatory inspections.

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 validation activities for process, equipment, cleaning, facility/utilities, and/or computerized systems 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.

Skills

Technical writing

Stakeholder management

Analytical thinking

GxP compliance

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering, Chemistry, Pharmacy, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related technical discipline

Tools

Kneat

ValGenesis

TrackWise

Veeva

Job description

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.