Principal QC Labs Engineer

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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 Med Tech, 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.

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We are searching for a Principal QC Labs Engineer. This Hybrid position can be based in Titusville, New Jersey, Springhouse, Pa, or Raritan, New Jersey. 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. As technical owner of systems, the Engineer 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.

• Represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user.
• Create or support the writing of URSs, Change Controls, Impact Assessments, technical evaluations, and operational documents.
• Secure relationships with equipment and technology partners to ensure smooth transition from project custody.
• Engage vendor for factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility.
• Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.).
• Support development of integrated process data map and criticality assessments for automation and manufacturing systems deliverables.
• Accountable for cost and resources within system(s) of responsibility.
• Participate in system installations, walkdowns, C&Q and turnover activities during construction phase.
• Develop asset management procedures, preventive maintenance, maintenance and calibration.
• Drive 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 quickly, 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.

• Minimum 6 years of relevant work experience.
• Experience in Manufacturing Operations, Laboratory Operations and/or Engineering environment.
• Experience with in Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry.
• Hands‑on experience in asset ownership (i.e., equipment, facilities, and utilities).
• 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…