Senior CQV Specialist

Looking for an experienced Sr. CQV Specialist to support Commissioning, Qualification, and Validation (CQV) activities in a cGMP cell therapy manufacturing environment
. The role involves validating equipment, facilities, utilities, systems, and manufacturing processes while ensuring regulatory compliance.

• Perform commissioning, qualification, requalification, and validation for equipment, facilities, utilities, and systems.
• Write, review, and execute validation protocols, reports, and documentation
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• Manage multiple CQV projects and work with QA, Manufacturing, Engineering, Facilities, and vendors.
• Support deviations, CAPAs, change controls, risk assessments, SOP updates, and investigations
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• Ensure compliance with cGMP, GDP, FDA regulations, and validation requirements
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• Participate in audits and regulatory inspections
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• Train junior team members on CQV processes.
• Support data integrity and compliance improvement initiatives
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• Bachelor’s degree in Engineering, Science, or related field.
• 5+ years of CQV/Validation experience in pharma, biotech, medical devices, or cell therapy
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• Experience in aseptic manufacturing and cGMP environments preferred.
• Experience in cell therapy, biologics, or sterile manufacturing is highly preferred.

• cGMP / cGTP compliance
• Equipment qualification & facility validation