Validation Program Lead
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-06-19
Listing for:
Harba
Full Time
position Listed on 2026-06-19
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Validation Engineer
Job Description & How to Apply Below
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
- 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
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