Process Lead

Title: Process Lead - CQV & AutomationLocation: Philadelphia, PADuration: 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 ResponsibilitiesLead process engineering activities for a greenfield cell therapy manufacturing facilityOversee the full CQV lifecycle (Commissioning, Qualification, Validation - IQ/OQ/PQ)Drive process performance qualification (PPQ) and validation strategiesPartner cross-functionally with Automation, MSAT, QA, and Engineering teamsSupport automation system integration (DeltaV, PLC, SCADA) aligned with process requirementsReview and approve validation protocols, reports, and technical documentationEnsure compliance with cGMP, FDA, and regulatory standardsIdentify and mitigate process and system risksProvide technical leadership and guidance across project teamsRequired QualificationsBachelor's or Master's degree in Chemical Engineering, Biotechnology, or related field12+ years of experience in biopharma / life sciencesStrong hands-on experience with CQV in GMP-regulated environmentsExperience with automation systems (DeltaV, Rockwell, Siemens, PLC/SCADA)Proven experience supporting process validation (IQ/OQ/PQ, PPQ)Excellent communication and cross-functional collaboration skillsPreferred QualificationsExperience supporting greenfield / facility startup projectsBackground in CAR-T, cell therapy, or gene therapy manufacturingExperience with Kneat or other electronic validation systemsStrong understanding of data integrity and 21 CFR Part 11

Created: 2026-05-08