Senior Manager, Execution Automation Systems

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Automation Engineering

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while fostering patients every step of the way.

Johnson & Johnson Innovative Medicines, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager – CAR-T Execution (Automation) Systems

Learn more at https://www.jnj.com/innovative-medicine.

#LI-Hybrid

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides enthusiastic prospects for patients where other therapies have failed to provide adequate results. JJIM is working to develop, manufacture, and commercialize products in the CAR-T space.

The Senior Manager CAR-T Execution (Automation) Systems is responsible for providing technical expertise, using standard methodologies, and developing internal as well as external partnerships within the CAR-T program at the site level and beyond. They will support the design and implementation of CAR-T manufacturing and laboratory (level 0 - 2) systems (PAS-X MES, Delta V, Aveva Pi, various PLC-Based equipment packages, and EMS). The role will ensure level 0 - 2 systems are closely integrated with process automation and robotics. They will be the business execution systems owner, and will closely collaborate with the different project organizations, vendors, sites, and partners. Daily, the Senior Manager partners with Operations, MSAT, IT, Quality, 3rd party partners, and Environment Health & Safety.

The Senior Manager CAR-T Execution (Automation) Systems will act as a decision maker in the Engineering workstream and partner with E&PS, IT, Operations and Quality to ensure manufacturing and laboratory execution systems meet operational requirements. You will lead and drive systems through Engineering, Procurement, and Construction Phases to ensure on-time system delivery. As technical owner of systems, the Senior Manager is responsible for qualified execution system turnover to the end user. You will collaborate in the development and own set-up of supply chain technology and processes for the design of a next-generation manufacturing facility.

Key Responsibilities:

• As CAR-T Execution Systems Owner, 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 ensuring business requirements are incorporated into the design.

• Ownership and SME for Execution Systems – secure relationships with systems and technology partners to ensure smooth transition from project to business owner custody. Provide technical support to Engineering/MAM, Design, Automation, IT, Construction Management, CQV/Start-up, Operations, and EHS teams as required during the project phase.

• In partnership with E&PS lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within systems of responsibility.

• Participate and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.).