Job Description
Senior Validation Specialist - CQV at Intellectt, Inc Senior Validation Specialist - CQV at Intellectt, Inc in Raritan, New Jersey Posted in 1 day ago.
Type:
full-time Job Description:
Role:
Sr. CQV Specialist Location:
Raritan, NJ Duration:
Long Term - Onsite Overview:
Our client, a leading organization within the cell therapy and biopharmaceutical manufacturing industry, is seeking an experienced Sr. CQV Specialist to support commissioning, qualification, and validation activities within a cGMP-regulated Clinical and Commercial Cell Therapy Manufacturing environment. This role will be responsible for executing and managing CQV activities related to facilities, utilities, equipment, systems, and manufacturing processes supporting personalized cell therapy production operations. The ideal candidate will bring strong experience within aseptic manufacturing environments, deep knowledge of cGMP regulations, and the ability to independently manage complex validation projects while collaborating across multiple functional teams. Key Responsibilities Execute commissioning, qualification, requalification, and validation activities for manufacturing facilities, utilities, equipment, and systems. Lead and manage multiple CQV projects while coordinating with cross-functional teams, vendors, and contractors. Author, review, and execute validation lifecycle documentation including protocols, reports, validation plans, and associated documentation. Support deviation investigations, CAPAs, remediation activities, and corrective actions. Participate in change control activities, SOP revisions, risk assessments, FMEAs, periodic reviews, and validation lifecycle management. Ensure all CQV activities are compliant with cGMP, GDP, FDA, and applicable regulatory requirements. Support regulatory inspections and internal audits by presenting CQV strategies, documentation, and compliance records. Train and mentor junior team members on CQV processes, compliance standards, and industry best practices. Support data integrity initiatives and continuous compliance improvements within manufacturing operations. Collaborate closely with Manufacturing, Quality Assurance, Engineering, Facilities, and Validation teams. Education Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline required. Experience 8+ years of CQV / Validation experience within pharmaceutical, biotechnology, medical device, or cell therapy manufacturing environments. Strong hands-on experience supporting aseptic manufacturing and cGMP-regulated operations. Prior experience supporting cell therapy, biologics, sterile manufacturing, or personalized medicine production environments is highly preferred.
