Senior Specialist, CTO MSAT Process Validation Engineer II - S12

Position Summary

The Senior Specialist, CTO MSAT Process Validation Engineer II is responsible for supporting the production of personalized cell therapy products for global clinical trials and commercial supply at the CTO Summit, NJ manufacturing site. The Senior Specialist develops and supports qualification and validation activities in a leading role, including protocols, reports, site procedures, batch records, and agency filing content to satisfy internal and external regulatory expectations.

The Senior Specialist collaborates with Global MSAT, Product and Development, Manufacturing Operations, Supply Chain, Quality Control, and Quality Assurance departments while providing technical support for the resolution of validation‑related project deliverables, evaluation and implementation of process changes, and continuous process improvement support to ensure rapid, flawless, compliant, and cost‑effective delivery of quality products.

• Support CAR‑T manufacturing site Process Validation activities, including, but not limited to, Aseptic Process Simulations/Validations (APS/APV), Process Performance Qualifications (PPQ), Dynamic Airflow Visualization Studies, Container Closure Integrity Testing (CCIT), Continued Process Verification (CPV) programs, and revalidation strategies to meet GMP deadlines and ensure regulatory compliance.
• Execute all responsibilities to meet cGMP and 21
  
  CFR Part
  11 data‑integrity requirements and maintain validation activities in a state of control and compliance.
• Contribute to development of process validation strategies, protocols, SOPs, and batch records for cell‑therapy manufacturing processes, as well as data analysis and compilation of results.
• Ensure process validation standards, site validation master plans, process qualification strategies, and CPV strategies are implemented consistently and support execution and closure of validation activities.
• Collaborate with internal and external cross‑functional teams for validation executions, tech transfers, and new product launches to ensure knowledge transfer, appropriate control strategies, risk analysis, and validation readiness.
• Support process validation lifecycle activities by ensuring a state of control is maintained through CPV programs.
• Coordinate and collaborate with other departments (Process Engineering, Facilities, Manufacturing Operations, Quality Control, Quality Assurance, Supply Chain, and Regulatory) to achieve objectives related to process validation executions and associated activities, including compliance with all applicable standards.
• Lead APS/APV, PPQ, and validation projects by providing technical oversight, coordinating preparation, training execution, and oversight, and reporting closures throughout the product lifecycle.
• Author, review, and approve process validation protocols and reports, data retrieval, compilation, and verification from a variety of 21
  
  CFRPart
  11 compliant electronic systems.
• Provide technical input, lead validation‑related deviations and investigations, perform root‑cause analysis, and implement CAPAs to ensure compliance with the validated state of the manufacturing process.
• Support and assess site validation impacts to change initiatives and implementation of process improvement initiatives via CAPAs and Change Controls to identify requirements necessary to maintain validated status.
• Author and support validation risk assessments for existing and new/changed processes.
• Must be able to work in controlled environments requiring clean‑room gowning in ISO5, ISO7, and ISO8 areas.
• Recognized as a subject‑matter expert (SME) within the group.
• Support process validation deliverables for Health Authority regulatory submissions and inspections, maintaining permanent inspection readiness.
• Support stakeholders in accomplishing productivity goals with internal and external cross‑functional teams.

• Create an environment of teamwork, open communication, and a sense of urgency.
• Support the change agent in promoting flexibility, creativity, and accountability.
• Support organizational strategic goals and objectives that are linked to the overall company strategy.
• Build…