Job Title: Senior CQV Engineer

Location: New York, NY

Job Description:

Our client, a leading organization in the medical device/pharmaceutical industry , is seeking an experienced Senior CQV (Commissioning, Qualification, and Validation) Engineer to lead validation activities for new and existing facilities, equipment, and processes. The ideal candidate will have a strong background in CQV methodologies, regulatory compliance, and hands-on execution of validation protocols.

Key Responsibilities:

• Develop and execute CQV strategies , including commissioning, qualification (IQ, OQ, PQ), and validation of equipment, utilities, and processes .
• Ensure compliance with FDA, cGMP, GAMP 5, and ISO 13485 regulations.
• Author, review, and approve CQV documentation , including protocols, reports, risk assessments, and deviations.
• Lead process validation (PV), cleaning validation (CV), and equipment validation (EV) efforts.
• Support facility start-up, FAT, SAT, and technology transfer activities.
• Collaborate with engineering, manufacturing, quality, and regulatory teams to drive validation projects.
• Identify and implement continuous improvements in CQV processes.
• Provide technical leadership and mentorship to junior engineers.

Required Skills & Qualifications:

• Bachelor’s/Master’s degree in Engineering, Life Sciences, or a related field.
• 8+ years of CQV experience in the medical device, pharmaceutical, or biotech industry.
• Extensive knowledge of IQ, OQ, PQ, validation life cycle, and GMP compliance .
• Strong understanding of FDA 21 CFR Part 11/820, EU Annex 15, ASTM E2500, ICH Q9/Q10 .
• Experience in cleanroom validation, aseptic processing, utilities (HVAC, WFI, Compressed Air) .
• Ability to lead multiple projects and work cross-functionally.
• Excellent problem-solving, communication, and technical writing skills.

Preferred Qualifications:

• Experience with automated manufacturing systems, MES, and CSV (Computer System Validation) .
• Six Sigma or Lean Manufacturing experience.
• Strong knowledge of biologics and sterile manufacturing processes .

Benefits & Perks:

• Competitive salary and benefits package
• Growth opportunities in a dynamic and innovative work environment
• Exposure to cutting-edge technologies and projects