Senior CQV Engineer

Job Title: Senior CQV Engineer Location: New York, NYJob 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 processesEnsure 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 complianceStrong understanding of FDA 21 CFR Part 11/820, EU Annex 15, ASTM E2500, ICH Q9/Q10Experience 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 processesBenefits & Perks:Competitive salary and benefits packageGrowth opportunities in a dynamic and innovative work environmentExposure to cutting-edge technologies and projects

Created: 2025-02-01