Sr CQV Specialist

Sr. CQV SpecialistLocation: Raleigh, NCEmployment Type: ContractWe are seeking an experienced Sr. CQV Specialist to support Commissioning, Qualification, and Validation (CQV) activities in a cGMP-regulated Cell Therapy manufacturing environment. This role will focus on qualification of facilities, utilities, equipment, and manufacturing processes while ensuring regulatory compliance.Key Responsibilities:Execute commissioning, qualification, requalification, and validation activities.Author, review, and execute CQV protocols, reports, and validation documentation.Support deviations, CAPAs, change controls, and risk assessments.Ensure compliance with cGMP, GDP, FDA, and applicable regulations.Collaborate with Manufacturing, QA, Engineering, and Facilities teams.Support audits, inspections, and data integrity initiatives.Manage multiple CQV projects and provide technical guidance as needed.Qualifications:Bachelor’s Degree in Engineering, Science, or related field.8+ years of CQV/Validation experience in pharmaceutical, biotech, medical device, or cell therapy environments.Strong experience in aseptic manufacturing and cGMP-regulated facilities.Experience with cell therapy, biologics, or sterile manufacturing is preferred.Technical Skills:CQV, Equipment Qualification, Facility ValidationcGMP/cGTP ComplianceChange Controls, Deviations, CAPAs, Risk AssessmentsValidation Lifecycle DocumentationData Integrity & GDP Practices Please send your updated resume to:rj@gandivainsights.com