CQV Validation Lead Job Type:

Full-Time Location:

Philadelphia, PA -

Hybrid Salary:

$150,000-$200,000 Job Summary We are seeking a CQV Validation Lead to manage computerized system validation activities within regulated Life Sciences environments. The role will lead validation projects from planning through execution and documentation while ensuring compliance with FDA and EU GMP requirements. Key Responsibilities Develop and execute VMP, IQ, OQ, and PQ protocols. Lead validation risk assessments, testing, and deviation management. Prepare and review validation documentation and traceability matrices. Collaborate with Engineering, Automation, QA, IT, and Project teams. Ensure compliance with

GAMP 5, 21 CFR

Part 11, and EU Annex 11 . Support audits, inspections, and client reviews. Mentor junior validation professionals and improve validation processes. Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. Exactly 5 years of hands-on Computerized System Validation (CSV) experience in

FDA/EU GMP

environments. Strong knowledge of

GAMP 5, 21 CFR

Part 11, and EU Annex 11 . Experience with MasterControl, TrackWise, or similar validation tools . Experience with DCS, PLC, SCADA, or MES environments. Strong documentation, analytical, communication, and project management skills. #

INA Pay:

$150,000.00 - $190,000.00 per hour

Benefits:

Dental insurance Health insurance Vision insurance Application Question(s): Please let me know your availability to speak Your current location zip code?

Experience:

GAMP:

5 years (Required)

CQV:

5 years (Required)

Work Location:

In person