Senior Process Engineer, Cell & Genetic Therapy Systems
Vertex Pharmaceuticals Incorporated
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Job summary
Vertex's Automation of Machinery and Process (AMP) Team is seeking a Principal Process Engineer to develop cutting-edge manufacturing solutions for its Cell & Genetic Therapies programs. This pivotal role leads cross-functional workstreams for equipment & systems development, process optimization, and technology transfer to deliver robust and reliable manufacturing systems.
You will partner with Manufacturing, Process Development, Quality, Validation, Facilities, MSAT, Project Management, and
Qualifications
- BS or MS in Engineering or related technical field.
- 10+ years of experience in cell & genetic therapy or related manufacturing.
- Experience with FMEA, CAPA and change control.
- Strong knowledge of cGMP/cGxP principles and 21 CFR Parts 210/211.
Responsibilities
- Lead design, specification, selection and lifecycle management of process equipment and systems.
- Direct requirements definition, reviews, commissioning, qualification and validation.
- Drive process optimization, reliability, scalability and technology transfer.
- Provide hands-on troubleshooting and manufacturing support when needed.
- Mentor junior engineers and ensure regulatory and quality compliance.
Skills
Education
Job description
Vertex's Automation of Machinery and Process (AMP) Team is seeking a Principal Process Engineer to develop cutting-edge manufacturing solutions for its Cell & Genetic Therapies programs. This pivotal role leads cross-functional workstreams for equipment & systems development, process optimization, and technology transfer to deliver robust and reliable manufacturing systems.
You will partner with Manufacturing, Process Development, Quality, Validation, Facilities, MSAT, Project Management, and
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