Senior Validation Engineer - Lead GMP Validation

Novozen Healthcare LLC; New York (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Novozen Healthcare LLC in New York seeks an experienced Senior Validation Engineer to lead equipment, process, cleaning, and CSV validation programs in a GMP environment.

You will develop validation plans, IQ/OQ/PQ, risk assessments, and support regulatory inspections while mentoring junior staff.

Strong collaboration with QA, Engineering, Regulatory Affairs, and external vendors is essential.

Qualifications

• Bachelor's degree in engineering or related field.
• 6–10 years of validation experience in pharmaceutical/biotech.
• Strong knowledge of FDA/cGMP regulations and 21 CFR Part 11.

Responsibilities

• Lead validation activities for equipment, processes, utilities, and facilities.
• Develop, review, and execute validation documents (PV plans, IQ/OQ/PQ, and final reports).
• Support C&Q activities for new equipment/facility expansions.
• Coordinate with QA, Regulatory, Manufacturing, and external vendors.

Skills

Validation leadership

Document control

Regulatory compliance

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering

Tools

ValGenesis

Kneat

MasterControl

TrackWise

Job description

Novozen Healthcare LLC in New York seeks an experienced Senior Validation Engineer to lead equipment, process, cleaning, and CSV validation programs in a GMP environment.

You will develop validation plans, IQ/OQ/PQ, risk assessments, and support regulatory inspections while mentoring junior staff.

Strong collaboration with QA, Engineering, Regulatory Affairs, and external vendors is essential.