Senior Manager Maintenance & Utilities

Senior Manager Maintenance & Utilities

Johnson & Johnson Innovative Medicines, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager Maintenance & Utilities. This hybrid position can be based in Titusville, New Jersey, Springhouse, PA, or Raritan, New Jersey.

At Johnson & Johnson Innovative Medicines (JJIM), we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat, and cure disease inspires us. We bring together the best minds and pursue the most promising science.

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 hopeful prospects to patients where other therapies have failed or fail to provide adequate results. JJIM is working to develop, manufacture, and commercialize products in the CAR-T space.

The CAR-T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIM's Advanced Therapies Supply Chain. Along the lifecycle of our assets, such as facilities, equipment, and utilities, this role is a key point of contact for technical matters.

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 be a key contributor to ensure flawless operation of utilities and facilities, asset replacement projects, and will closely collaborate with the different project organizations, vendors, sites, and partners.

In addition, the role will oversee the day-to-day business of maintenance and calibration activities and ensure flawless liaison with the different teams, vendors, sites, and stakeholders.

The ideal candidate will possess a strong track record in manufacturing asset maintenance as well as calibration, business acumen, proactive communication, and a willingness to be hands-on in key aspects of maintenance operations. Daily, the Senior Manager partners with Facilities, Operations, MSAT, Quality, and 3rd party partners, as well as Environment Health & Safety.

The Senior Manager Maintenance & Utilities 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. As technical owner of maintenance and clean utility systems, the Senior Manager is responsible for qualified 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 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 ownership for Asset Management and Reliability strategy.

Create or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, and operational documents. Ensure business requirements are incorporated into the design; responsible for business owner approval of requirement specifications.

Ownership for equipment / technology secure relationships with equipment and technology partners to ensure smooth transition from project custody.

In partnership with E&PS and Standard Design Platform, lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility.

Develop asset management strategy, including CMMS system selection, design, master data, maintenance and calibration procedures.

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

Ensures flawless execution of planned preventive and corrective maintenance and calibration activities for manufacturing, facilities, utilities and laboratory equipment.

Establish and manage KPIs and tracking tools across the scope of maintenance operations.

Accountable for cost and resources within system(s) of responsibility.

During the facility construction phase, participate and support system installations, walkdowns, C&Q and turn-over activities.

Drive the standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and clean / GMP utilities.

Accompany all stages of a typical asset 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 foster expertise sharing with CAR-T entities around the globe.

Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings.

In addition, a portion of your time will be focused on developing detailed knowledge of CAR-T production processes. You will be responsible for developing and maintaining and manufacturing environment to include facilities, utilities, equipment, and systems processes. This to include development and maintain an understanding of aseptic and cell processing techniques and an expertise of cell processing robotics and automation. A clear understanding of regulatory frameworks, GMP with a focus on ATMP.

Qualifications :

Education : A minimum of a Bachelor's is required. An advanced degree with a focus in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, or Biochemistry is preferred.

Required :

Experience and Skills : A minimum 8 years of relevant work experience is required. Experience in Manufacturing Operations and / or Engineering environment. Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry. Hands-on experience in asset ownership (i.e., equipment, facilities, and utilities) Hands-on experience leading maintenance and calibration activities. Previous in-depth experience with CMMS is a must (SAP / PM preferred). Experience with health authority inspections as well as internal and external audits. Experience managing 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 manage the workload and as required, be able to manage 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. Demonstrated ability to collaborate internally and externally within a matrix environment. Demonstrated start-up mindset, and you 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 successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.

Preferred : Experience with equipment / systems commissioning / qualification / validation, Process Automation, IT manufacturing systems, cell therapy (CAR-T) is an asset. Experience with Robotics equipment / technology in a manufacturing environment. 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.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs