Senior Manager Maintenance & Utilities

Johnson & Johnson Innovative Medicines (JJIM) is recruiting for a Senior Manager – Maintenance & Utilities. This Hybrid position can be based in Titusville, NJ; Spring House, PA; or Raritan, NJ. Our CAR-T Engineering organization provides ownership and oversight for the entire asset portfolio and related business processes for JJIM’s Advanced Therapies Supply Chain. The Senior Manager Maintenance & Utilities is responsible for providing technical expertise, using best practices, and developing internal as well as external partnerships within the CAR-T program at the site level and beyond. They will contribute to flawless operation of utilities and facilities, asset replacement projects, and collaboration with project organizations, vendors, sites, and partners. The role also oversees day-to-day maintenance and calibration activities and ensures effective liaison with teams, vendors, sites, and stakeholders. The ideal candidate will have a strong track record in manufacturing asset maintenance and calibration, business acumen, proactive communication, and a hands-on approach to maintenance operations. Daily responsibilities include partnering with Facilities, Operations, MSAT, Quality, and 3rd party partners, as well as Environment Health & Safety. You will act as a decision maker in the Engineering workstream and partner with E&PS, Standard Design Platforms, Operations and Quality to ensure facility and clean utilities design meet operational and reliability requirements. You will manage and drive engineering systems through Engineering, Procurement, and Construction phases to ensure on-time system delivery and will be the technical owner of maintenance and clean utility systems, responsible for qualified system turnover to the end user. You will collaborate in developing and owning set-up of supply chain technology and processes for a next-generation manufacturing facility. Key Responsibilities: As CAR-T Engineering System Owner, represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user. Support tech transfer activities through process validation and regulatory approval. Ownership for clean utility systems throughout project execution, such as Cleanroom HVAC, Emergency Power/UPS, Industrial Gases, Waste Handling technology, etc. Develop and own Asset Management and Reliability strategy. Write or support URSs, Change Controls, Impact Assessments, technical evaluations, and operational documents. Ensure business requirements are incorporated into the design; obtain business owner approval of requirement specifications. Ownership for equipment/technology – secure relationships with equipment and technology partners to ensure smooth transition from project custody. Lead vendor engagement, FAT/SAT within system of responsibility in partnership with E&PS and Standard Design Platform. Develop asset management strategy, including CMMS system selection, design, master data, maintenance and calibration procedures. Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.). Ensure flawless execution of planned preventive and corrective maintenance and calibration for manufacturing, facilities, utilities and laboratory equipment. Establish and manage KPIs and tracking tools across maintenance operations. Accountable for cost and resources within system(s) of responsibility. During facility construction, participate in system installations, walkdowns, C&Q and turnover activities. Drive standards for the asset portfolio and provide asset ownership as a service for production/lab equipment, facilities, and clean/GMP utilities. Support all stages of asset lifecycle, including replacement planning and vendor evaluation/selection. Support investigations, deviations, corrective and preventive actions for timely and compliant closure. Participate in compliance inspections/audits; ensure compliance with cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and company standards. Communicate regularly with the Engineering community and share expertise with CAR-T entities globally. Analyze processes to identify opportunities for optimization and cost savings. In addition, a portion of time will be focused on developing knowledge of CAR-T production processes. You will be responsible for developing and maintaining a manufacturing environment including facilities, utilities, equipment, and system processes, with understanding of aseptic/cell processing techniques and robotics/automation. A clear understanding of regulatory frameworks and GMP with a focus on ATMP. Qualifications Education:

A minimum of a Bachelor’s degree is required. An advanced degree with a focus in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, or Biochemistry is preferred. Experience and Skills: Minimum 8 years of relevant work experience. Experience in Manufacturing Operations and/or Engineering. Experience in Pharmaceuticals, Biopharmaceuticals/Large Molecule, or equivalent industry. Hands-on asset ownership experience (equipment, facilities, utilities). Hands-on experience leading maintenance and calibration activities. Experience with CMMS (SAP/PM preferred). Experience with health authority inspections and audits. Experience managing change, vendor management, and change control. In-depth knowledge of GMP standards related to equipment, utilities, and facilities commissioning/qualification (ISO, EN, ICH, FDA, ISPE). Ability to prioritize and manage workload with shifting priorities and deadlines. Service-minded, proactive collaboration with teams, and hands-on involvement in engineering and asset ownership. Ability to work collaboratively in a matrix environment and lead as a change agent. Independent work style with ability to manage multiple tasks and cross-functional issues. Preferred Experience with equipment/systems commissioning/qualification/validation, Process Automation, IT manufacturing systems, and cell therapy (CAR-T) is an asset. Experience with Robotics equipment/technology in manufacturing. Other Requires up to 30% domestic and/or international travel. The anticipated base pay range for this position is $120,000 - $207,000. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. The anticipated base pay range for this position is 120,000-207,000. Additional pay transparency information is available in the company benefits description and pay transparency sections on the Johnson & Johnson careers site.

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