Senior Validation Enginner
About The Position
As a trusted validation engineer, you will influence projects from concept through operational release and partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT. You will help build a culture in which quality, innovation, and compliance strengthen one another. The role leads validation strategy and lifecycle deliverables, supports qualification and continued control of GMP assets and systems, and advances the validation program through risk-based practices and effective cross-functional collaboration. You will support commissioning, qualification, and validation (CQV) for GMP equipment, facilities, utilities, and manufacturing systems, as well as computer systems validation (CSV) across the system lifecycle. You will also support investigations and change processes, represent validation during audits and inspections, and coach project teams and less-experienced validation colleagues. The position requires a bachelor's degree in a technical discipline and at least seven years of validation experience in a regulated GMP environment. Desirable experience includes cell therapy, biologics or sterile manufacturing, GxP platforms, validation systems, temperature mapping, cleanroom and utilities qualification, environmental monitoring systems, and cross-functional project leadership.
Requirements
- Bachelor's degree in Engineering (preferred), Computer Science, Biotechnology, or a related technical discipline.
- At least 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, and environmental monitoring systems.
- Cross-functional project leadership experience.
Responsibilities
- Lead and coordinate validation strategies and lifecycle deliverables, translating risk, regulatory expectations, and business needs into clear plans, robust testing, traceability, and defensible conclusions.
- Guide 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 systems validation (CSV) across the full system lifecycle, developing requirements, specifications, risk assessments, testing, traceability, and summary documentation for GxP systems.
- Provide validation impact assessments for 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 approaches.
- Lead and support deviations, CAPAs, change controls, and investigations, using 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 teams around priorities, schedules, status, and proactive 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
