Validation Program Lead
Harba
Job Responsibilities Own verification strategy from basic design through execution Define system boundaries, risk‑based approach, and integrated C&Q model Lead and scale a multi‑discipline CQV organization (20+ at peak) Act as senior interface to GFD, EPCs, OEMs, QA, MSAT, and Operations Drive schedule‑critical decisions with minimal supervision Ensure inspection‑ready delivery aligned to GMP, ASTM E2500, ISPE Establish governance, reporting, escalation, and execution cadence Qualifications 10+ years progressive experience across C&Q, validation, and capital projects Proven leadership of large‑scale GMP capital programs ($200M–$1B) Demonstrated ownership of design‑phase verification strategy API / peptide / complex purification manufacturing strongly preferred Experience leading commissioning‑forward, risk‑based C&Q models Prior Lilly experience highly valued but not required #J-18808-Ljbffr Harba
Vacancy posted 3 days ago
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