What are the responsibilities and job description for the Process Lead position at Unicon Pharma Inc?
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
Salary : $70 - $90