Senior Validation Enginner

As a trusted validation engineer, you will influence projects from concept through operational release, partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT, and help build a culture in which quality, innovation, and compliance strengthen one another.   Typical Accountabilities •         Lead/coordinate validation strategies and lifecycle deliverables that translate risk, regulatory expectations, and business needs into clear plans, robust testing, traceability, and defensible conclusions. •         Guide the qualification and continued control of GMP facilities, utilities, equipment, temperature-controlled storage units, manufacturing systems, and laboratory equipment that support dependable operations. •         Direct protocol planning and execution, evaluate installations and changes, and integrate commissioning, calibration, maintenance, and engineering evidence into sound qualification decisions. •         Support CSV across the full system lifecycle, developing rigorous requirements, specifications, risk assessments, testing, traceability, and summary documentation for GxP systems. •         Provide forward-looking validation impact assessments for software upgrades, patches, infrastructure changes, periodic reviews, and lifecycle maintenance, ensuring systems remain fit for intended use. •         Champion cGMP, data integrity, 21 CFR Part 11, EU GMP Annex 1, GAMP 5, site procedures, and company validation standards through practical, risk-based application. •         Lead and support deviations, CAPAs, change controls, and investigations, using disciplined root-cause analysis and effectiveness verification to convert issues into lasting improvement. •         Represent validation with confidence during internal audits, regulatory inspections, and customer audits, supported by accurate, complete, and inspection-ready documentation. •         Elevate the validation program by developing procedures, templates, standards, and risk-based practices that improve consistency, efficiency, and lifecycle governance. •         Bring cross-functional teams together around clear priorities, realistic schedules, transparent status, and proactive risk mitigation across Engineering, Manufacturing, Quality, Facilities, MS&T, and IT. •         Grow organizational capability by coaching project teams and less-experienced validation colleagues, sharing knowledge, and modeling strong technical judgment and quality leadership.   Qualifications and Skills Essential: • 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; and a 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. Desirable: • Experience supporting cell therapy (clinical/commercial stages), biologics, or sterile manufacturing; MES, ERP, LIMS, SCADA, BMS, EMS, laboratory computerized systems, or similar GxP platforms; • Veeva Vault, SAP, paperless validation systems, Blue Mountain, or equivalent systems; • temperature mapping, cleanroom and utilities qualification, environmental monitoring systems, and cross-functional project leadership.   Date Posted 16-Oct-2026 Closing Date 30-Oct-2026 Our mis