OSD CQV Lead — Validation & Digital Documentation

Katalyst CRO

Town of Florida (NY)

On-site

USD 120,000 - 180,000

Full time

14 days+

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Katalyst CRO in the United States is seeking a CQV Lead (OSD Manufacturing) with strong engineering fundamentals and hands-on CQV experience in a GMP-regulated Oral Solid Dose environment. You will lead end-to-end CQV activities for manufacturing equipment, packaging systems, utilities, facilities, and computerized systems to ensure validated, inspection-ready state.

The role emphasizes a digital-first approach to validation, collaboration with QA, Automation, Engineering, and Manufacturing, and

Qualifications

Master's or PhD in Engineering with 3+ years CQV in GMP OSd environments
Proven ability to author IQ/OQ/PQ protocols and validation reports
Experience with CSV, data integrity, and 21 CFR Part 11 compliance

Responsibilities

Lead CQV for OSD manufacturing and packaging systems
Develop risk-based IQ/OQ/PQ protocols aligned with CQAs and CPPs
Translate URS, FS/DS, and design specs into acceptance criteria
Evaluate system performance, ranges, and reliability
Utilize digital tools to generate validation documentation (protocols, reports, RTMs)
Maintain inspection-ready documentation at all times
Lead/change controls, deviations, and CAPA in a CGMP/regulatory context
Collaborate with QA, Automation, Engineering, and Manufacturing teams