Senior Manager, Execution Automation Systems

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

9d•Hybrid

About The Position

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.

Requirements

Minimum of a Bachelor’s is required; an advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field.
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. commissioning/qualification/validation.
Experience leading and influencing change, including vendor management, change control, and/or asset replacement strategies/activities.
In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, ISPE).
Ability to prioritize and handle the workload and as required, be able to lead shifting priorities based on critical deadlines so that business needs are always met.
Service mentality and ability to proactively collaborate with teams and partners, working hands-on on aspects of Engineering and asset ownership, while identifying areas of improvement.
Proven ability to collaborate internally and externally within a matrix environment.
Demonstrated start-up attitude, and proactively search for solutions.
You prioritize and provide clear instructions to peers.
You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/ guidelines which require strict execution.
You work independently and optimally, prioritizing and leading multiple tasks simultaneously, and integrating multi-functional issues.
Requires up to 50% domestic and/or international travel.

Nice To Haves

Experience with Cell Therapy (CAR-T) is an asset.
SME - DeltaV Administrator
Experience with DeltaV Continuous and Batch Configuration
SME - CSV/GAMP 5/Data Integrity
Experience solving/modeling MBRs using Korber PAS-X
Experience with the setup and programming of various CAR-T processing units
Experience with MiR Fleet Management software/MiR Robots/Staubli End Effectors
Experience with Warehouse ASRS (auto store/auto retrieve) systems automation
Experience with Biosero lab systems and automated lab instrumentation (cell counters and flow cytometers)
Experience programming and solving Python Code
Experience with Allen Bradley PLCs/Siemens PLCs/Beckhoff Industrial PC.

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.).
Coordinate the selection and oversight of third-party automation and design services by authoring and initiating formal RFP documentation for driven bidding and selecting automation vendors through execution of objective and data driven analysis documented in bid analysis forms..
Support development of the integrated process data map as well as criticality assessments used to define automation and manufacturing systems work.
Accountable for cost and resources within system(s) of responsibility.
During the facility construction phase, participate and support system testing, C&Q, and turn-over activities.
Develop asset management procedures and PMs for execution systems.
Accompany all stages of a typical system lifecycle, including replacement planning & vendor evaluation / selection.
Support resolving of technical issues or roadblocks as fast as possible including lessons learned.
Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure.
Participate in compliance inspections / audits within area of responsibility.
Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards.
Actively communicate regularly with the Engineering community and develop expertise sharing with CAR-T entities around the globe.
Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings.
Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes).
Develop & maintain robust understanding of aseptic and cell processing techniques.
Develop & maintain an in-depth knowledge of cell processing robotics and automation.
Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP.)