Lead Validation Engineer – GMP/GxP Life Sciences

Katalyst-Healthcares-; City of Rochester (NY); On-site; USD 110,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC in Rochester, NY is seeking a Validation Lead to oversee end-to-end validation activities in regulated life sciences environments. You will develop validation strategies, coordinate cross-functional teams, and ensure compliance with GMP/GxP, FDA, and data integrity standards.

You will lead the validation lifecycle across process, equipment, facilities, and computerized systems, driving timely delivery and audit readiness while mentoring validation engineers and

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmacy, Life Sciences, Biotechnology, 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.

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.

Skills

Leadership

Project management

Cross-functional coordination

Technical writing

Regulatory knowledge

Analytical thinking

Problem-solving

Stakeholder management

Education

Bachelor's degree in Engineering

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.