Senior Validation Enginner

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