Cell Therapy CQV Engineer — GMP Validation Lead

Katalyst CRO; Raritan (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in New Jersey seeks a senior CQV professional to support commissioning, qualification and validation for our cell therapy manufacturing plant, ensuring compliant operations and data integrity. You will lead CQV protocols, summary reports, CAPAs and investigations, mentor junior staff, and coordinate with QA, manufacturing and regulatory teams for audits and product release.

Candidates should have 8+ years of CQV experience in aseptic cell therapy environments, with strong

Qualifications

• Bachelor's degree in science, engineering, or equivalent
• 8+ years of relevant experience in aseptic or cell therapy manufacturing
• Experience with CQV in cGMP environments
• Knowledge of FDA/EU guidance for cell-based products
• Strong communication and cross-functional collaboration

Responsibilities

• Lead commissioning, qualification, requalification, and validation activities in the plant.
• Manage multiple CQV projects with cross-functional teams and report status.
• Own investigations, CAPAs, and remediation plans.
• Prepare CQV master/test protocols, summaries, and data packages.
• Develop risk assessments, FMEAs, and periodic qualifications.
• Train junior staff; support regulatory and internal audits.
• Ensure data integrity and adherence to cGMP/cGTP requirements.

Skills

CQV expertise

Regulatory audits

Project management

Team mentoring

Communication skills

Detail oriented

Independent worker

Education

Bachelor's Degree in Science/Engineering

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye AVS

Kaye Valprobe

Microsoft Office Suite

Job description

Katalyst CRO in New Jersey seeks a senior CQV professional to support commissioning, qualification and validation for our cell therapy manufacturing plant, ensuring compliant operations and data integrity. You will lead CQV protocols, summary reports, CAPAs and investigations, mentor junior staff, and coordinate with QA, manufacturing and regulatory teams for audits and product release.

Candidates should have 8+ years of CQV experience in aseptic cell therapy environments, with strong