Senior Validation Enginner
About The Position
The Senior Validation Engineer influences projects from concept through operational release and partners across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT. The role supports a culture where quality, innovation, and compliance reinforce one another. The position leads validation strategies and lifecycle deliverables, including qualification and continued control of GMP facilities, utilities, equipment, temperature-controlled storage units, manufacturing systems, and laboratory equipment. It directs protocol planning and execution, evaluates installations and changes, and integrates commissioning, calibration, maintenance, and engineering evidence into qualification decisions. The role also supports computer system validation across the full lifecycle, including requirements, specifications, risk assessments, testing, traceability, and summary documentation. It assesses the validation impact of upgrades, patches, infrastructure changes, periodic reviews, and lifecycle maintenance. The Senior Validation Engineer applies cGMP, data integrity, 21 CFR Part 11, EU GMP Annex 1, GAMP 5, site procedures, and company validation standards using a practical, risk-based approach. Additional responsibilities include leading or supporting deviations, CAPAs, change controls, and investigations; representing validation during audits and inspections; improving procedures, templates, standards, and lifecycle governance; coordinating cross-functional priorities and risks; and coaching project teams and less-experienced validation colleagues.
Requirements
- Bachelor’s degree in Engineering (preferred), Computer Science, Biotechnology, or a related technical discipline.
- Minimum seven years of validation experience in a regulated pharmaceutical, biotechnology, medical-device, or comparable GMP environment.
- Demonstrated experience with CQV for GMP equipment, utilities, facilities, or manufacturing systems.
- Experience supporting CSV throughout the system lifecycle.
- Strong record of authoring, reviewing, and approving validation documentation.
- Strong working knowledge of GMP and GDP requirements, ISPE GAMP 5, risk-based validation, data integrity, 21 CFR Part 11, EU GMP Annex 1, change control and CAPA systems, the DQ/IQ/OQ/PQ lifecycle, Validation Master Plans, and validation maintenance programs.
Nice To Haves
- Experience supporting cell therapy at clinical or commercial stages, biologics, or sterile manufacturing.
- Experience with MES, ERP, LIMS, SCADA, BMS, EMS, laboratory computerized systems, or similar GxP platforms.
- Experience with Veeva Vault, SAP, paperless validation systems, Blue Mountain, or equivalent systems.
- Experience with temperature mapping, cleanroom and utilities qualification, environmental monitoring systems, and cross-functional project leadership.
Responsibilities
- Lead and coordinate validation strategies and lifecycle deliverables, translating risk, regulatory expectations, and business needs into plans, testing, traceability, and conclusions.
- Guide the qualification and continued control of GMP facilities, utilities, equipment, temperature-controlled storage units, manufacturing systems, and laboratory equipment.
- Direct protocol planning and execution, evaluate installations and changes, and integrate commissioning, calibration, maintenance, and engineering evidence into qualification decisions.
- Support computer system validation across the system lifecycle, including requirements, specifications, risk assessments, testing, traceability, and summary documentation for GxP systems.
- Assess validation impacts of software upgrades, patches, infrastructure changes, periodic reviews, and lifecycle maintenance.
- Apply cGMP, data integrity, 21 CFR Part 11, EU GMP Annex 1, GAMP 5, site procedures, and company validation standards using practical, risk-based methods.
- Lead and support deviations, CAPAs, change controls, and investigations, applying root-cause analysis and effectiveness verification.
- Represent validation during internal audits, regulatory inspections, and customer audits, maintaining accurate, complete, inspection-ready documentation.
- Develop procedures, templates, standards, and risk-based practices to improve validation consistency, efficiency, and lifecycle governance.
- Coordinate cross-functional priorities, schedules, status, and risk mitigation across Engineering, Manufacturing, Quality, Facilities, MS&T, and IT.
- Coach project teams and less-experienced validation colleagues, share knowledge, and model strong technical judgment and quality leadership.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
