CAR-T CQV & Automation Process Lead (Greenfield)

Unicon Pharma Inc; Philadelphia (Philadelphia County); On-site; USD 137,760 - 206,640; Full time

Job summary

Unicon Pharma Inc is looking for an experienced Process Lead to support a greenfield CAR-T manufacturing facility in Philadelphia. This role involves leading process validation strategy, supporting automation integration, ensuring compliance with cGMP and regulatory standards, and providing technical leadership. Candidates should have a Bachelor’s or Master’s degree in Chemical Engineering/Biotechnology, 12+ years in biopharma, and strong CQV expertise. This position offers a long-term contract with rolling starts and competitive hourly pay.

Qualifications

• 12+ years of experience in biopharma / life sciences.
• Strong hands-on experience with CQV in GMP-regulated environments.
• Proven experience supporting process validation (IQ/OQ/PQ, PPQ).

Responsibilities

• Lead process engineering activities for a greenfield cell therapy manufacturing facility.
• Oversee the full CQV lifecycle (Commissioning, Qualification, Validation – IQ/OQ/PQ).
• Drive process performance qualification (PPQ) and validation strategies.

Skills

CQV expertise

Automation systems

Process validation

Cross-functional collaboration

Technical leadership

Education

Bachelor’s or Master’s degree in Chemical Engineering, Biotechnology, or related field

Tools

DeltaV

PLC

SCADA

Job description

Unicon Pharma Inc is looking for an experienced Process Lead to support a greenfield CAR-T manufacturing facility in Philadelphia. This role involves leading process validation strategy, supporting automation integration, ensuring compliance with cGMP and regulatory standards, and providing technical leadership. Candidates should have a Bachelor’s or Master’s degree in Chemical Engineering/Biotechnology, 12+ years in biopharma, and strong CQV expertise. This position offers a long-term contract with rolling starts and competitive hourly pay.