Sr. CQV Specialist - 174084 - 174788

Responsibilities: of the Sr CQV Specialist : • Execute commissioning, qualification, requalification, and validation activities for facilities, equipment, utilities, and processes • Author and execute CQV protocols, reports, and associated documentation ensuring compliance and data integrity • Lead or support deviations, investigations, CAPAs, corrections, and remediation efforts • Manage multiple CQV projects while collaborating with cross-functional teams and vendors • Support change controls, risk assessments, FMEAs, periodic reviews, and validation lifecycle activities • Present CQV activities during regulatory inspections and internal audits • Train and mentor junior team members on CQV processes and best practices Qualifications: of the Sr CQV Specialist: • Bachelor's degree in Science, Engineering, or a related technical discipline • 8+ years of CQV experience within pharmaceutical, biotech, biologics, or cell therapy manufacturing environments • Strong knowledge of cGMP, cGTP, FDA/EU regulations, and validation lifecycle principles • Experience with investigations, CAPAs, change controls, and remediation activities • Familiarity with Kneat, Maximo, Siemens EMS, Comet, Kaye AVS, and Kaye ValProbe preferred • Ability to work independently, manage shifting priorities, and mentor junior engineers • Strong communication skills with experience supporting audits and inspections Compensation: for the Sr CQV Specialist includes : • Salary range: $55-60/hr • 6-month contract opportunity with the potential for extension • Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave (as required by law), and Paid Holidays This job opens for applications on 09/20/2026. Applications for this job will be accepted for at least 30 days from the posting date.