Senior Manager overseeing CAR-T Execution Automation Systems in Innovative Medicine at Johnson & Johnson. Responsible for technical expertise and collaboration in the CAR-T program.
Responsibilities
Represent Engineering in Facility & Systems Design, Qualification and Startup, through transfer to the end user.
Support tech transfer activities through process validation and regulatory approval.
Author, approve or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, design specifications and operational documents.
Provide technical support to Engineering/MAM, Design, Automation, IT, Construction Management, CQV/Start-up, Operations, and EHS teams as required during the project phase.
Participate and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.).
Requirements
Minimum 8 years of Manufacturing OT and Automation work experience in a Manufacturing Operations and/or Engineering environment.
Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry.
Experience working with Emerson DeltaV process and batch control systems.
Thorough knowledge of ISA S88/S95 standards.
Experience with PLC-controlled equipment, process automation hardware and software, robotics, OT networks infrastructure and systems.
Bachelor’s degree is required; advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field.
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