Principal QC Labs Engineer

About Johnson & Johnson

Johnson & Johnson believes health is everything and aims to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and Med Tech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity. Learn more at

Position:
Principal QC Labs Engineer (CAR‑T) – Hybrid
Locations:
Titusville, New Jersey;
Springhouse, Pennsylvania;
Raritan, New Jersey.
Job Function:
Supply Chain Engineering
Job Sub‑Function:
Manufacturing Engineering
Job Category:
Scientific/Technology.

• Serve as CAR‑T Engineering System Owner, representing Engineering in Facility & Equipment Design, Qualification, Startup, and transfer to end user.
• Create or support URS, Change Controls, Impact Assessments, technical evaluations, and operational documents; secure business owner approval.
• Own equipment/technology relationships to ensure smooth transition from project custody.
• Engage with vendors for FAT/SAT and participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics).
• Develop process data map and criticality assessments for automation and manufacturing systems.
• Accountable for cost and resources within the assigned system.
• Participate in system installations, walk‑downs, C&Q, and turnover activities during construction.
• Develop asset management procedures, PM, maintenance, and calibration.
• Drive standards for the asset portfolio and provide asset ownership services.
• Oversee asset lifecycle planning, vendor evaluation, and selection.
• Resolve technical issues and drive continuous improvement, including lessons learned.
• Investigate deviations, CAPAs, and ensure timely, compliant closure.
• Participate in compliance inspections and audits.
• Ensure compliance with cGMPs, regulatory requirements, safety, environmental regulations, SOPs, WIs, and company policies.
• Communicate regularly with Engineering community and foster expertise sharing.
• Analyze processes for optimization, efficiency, and cost savings.

• Develop and maintain in‑depth understanding of CAR‑T manufacturing processes, operational procedures, and environment.
• Understand aseptic and cell processing techniques.
• Maintain knowledge of cell processing robotics and automation.
• Understand relevant regulatory frameworks (GMP, ATMP).

• Minimum Bachelor’s or equivalent University Degree; advanced degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry, or related field.
• 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 (equipment, facilities, utilities).
• Experience managing change, vendor management, change control, or asset replacement strategies.
• In‑depth knowledge of current GMP standards and guidelines (ISO, EN, ICH, FDA, ISPE).
• Ability to prioritize and manage workload, shifting priorities based on critical deadlines.
• Service mentality, proactive collaboration, and skill in identifying improvement areas.
• Demonstrated collaboration within a matrix environment.
• Start‑up mindset and proactive solution‑seeking.
• Strong communication and leadership skills.
• Ability to thrive in a rapidly changing environment and lead as a change agent.
• Strong independent work ethic and multitasking ability.

• Experience with equipment/system commissioning/qualification/validation, laboratory analytical instruments, process automation, IT manufacturing systems, and cell therapy (CAR‑T).

• Requires up to 30% domestic and/or international travel.

Base pay range: $100,000 to $172,500 per year.

Employees and eligible dependents are eligible to participate in company‑sponsored benefits: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Employees may also join the company’s consolidated retirement plan…