Sr. CQV Specialist

The Sr. CQV Specialist will support Commissioning, Qualification, and Validation activities in a cGMP Clinical and Commercial Cell Therapy Manufacturing environment. The role involves managing validation projects for facilities, utilities, equipment, systems, and manufacturing processes while ensuring compliance with FDA, EU cGMP, cGTP, GDP, and other regulatory requirements.

Key Responsibilities

• Execute commissioning, qualification, requalification, and validation activities for facilities, utilities, equipment, and systems.
• Prepare, review, and execute CQV protocols, validation plans, summary reports, and related documentation.
• Manage multiple CQV projects while coordinating with Manufacturing, QA, Engineering, Facilities, vendors, and contractors.
• Support deviation investigations, CAPAs, change controls, remediation activities, risk assessments, and periodic reviews.
• Ensure all CQV activities comply with cGMP, GDP, FDA, EU, and applicable regulatory standards.
• Support regulatory inspections and internal audits by presenting validation strategies and documentation.
• Train and mentor junior team members on CQV processes and best practices.
• Support data integrity initiatives and compliance improvements within manufacturing operations.

Required Skills

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 8+ years of CQV/Validation experience in pharmaceutical, biotech, medical device, or cell therapy industries.
• Strong knowledge of cGMP, cGTP, GDP, FDA, EU cGMP, 21 CFR Parts 210, 211, and 1271, and ICH guidelines.
• Experience with CQV, equipment qualification, facility validation, validation lifecycle documentation, change controls, deviations, CAPAs, and risk assessments.
• Familiarity with Microsoft Office Suite and validation/compliance systems such as Maximo, Siemens EMS, Comet, Kneat, Kaye AVS, and Kaye ValProbe.

Preferred Skills

• Experience in aseptic manufacturing, sterile manufacturing, biologics, or cell therapy operations.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities independently.
• Excellent troubleshooting and problem-solving skills.
• Experience supporting audits and regulatory inspections.
• Ability to work effectively with cross-functional teams For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com.