Job Details

Title: Process Lead – CQV & Automation

Location: Philadelphia, PA

Duration: Longterm Contract (likely through 2031)

Start: Rolling Starts (ongoing need)

Greenfield CAR-T Manufacturing Facility

*Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate.

We are seeking an experienced Process Lead with deep CQV and Automation expertise to support a greenfield CAR-T manufacturing facility. This is a high-impact role responsible for driving process validation strategy, supporting automation integration, and ensuring compliance in a cutting-edge cell therapy environment.

This is an exciting opportunity to play a key role in building a facility from the ground up and shaping next-generation manufacturing processes.

Key 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
• Partner cross-functionally with Automation, MSAT, QA, and Engineering teams
• Support automation system integration (DeltaV, PLC, SCADA) aligned with process requirements
• Review and approve validation protocols, reports, and technical documentation
• Ensure compliance with cGMP, FDA, and regulatory standards
• Identify and mitigate process and system risks
• Provide technical leadership and guidance across project teams

Required Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Biotechnology, or related field
• 12+ years of experience in biopharma / life sciences
• Strong hands-on experience with CQV in GMP-regulated environments
• Experience with automation systems (DeltaV, Rockwell, Siemens, PLC/SCADA)
• Proven experience supporting process validation (IQ/OQ/PQ, PPQ)
• Excellent communication and cross-functional collaboration skills

Preferred Qualifications

• Experience supporting greenfield / facility startup projects
• Background in CAR-T, cell therapy, or gene therapy manufacturing
• Experience with Kneat or other electronic validation systems
• Strong understanding of data integrity and 21 CFR Part 11