Principal QC Labs Engineer

Position Overview

At Johnson & Johnson, we believe health is everything. Our expertise in Innovative Medicine inspires breakthroughs that prevent, treat, and cure complex diseases. We are searching for a Principal QC Labs Engineer to join our CAR-T Engineering organization and help develop treatments, find cures, and bring transformative technology from the lab to life. This Hybrid role can be based in Titusville, New Jersey; Springhouse, Pennsylvania; or Raritan, New Jersey. Learn more at https://www.jnj.com.

Key Responsibilities

• Represent Engineering in facility and equipment design, qualification, and startup, ensuring a smooth transfer to the end user, and support tech transfer activities through process validation and regulatory approval.
• Create or support the writing of URSs (User Requirement Specifications), change controls, impact assessments, technical evaluations, and operational documents while ensuring business requirements are met.
• Assume ownership for equipment/technology by securing relationships with partners to ensure smooth project custody transitions.
• Partner with the E&PS lead to engage vendors and oversee factory acceptance testing (FAT) and site acceptance testing (SAT) within the system of responsibility.
• Participate in safety reviews (including EHS by Design, HAZOPs, machine safety, and ergonomics) and take ownership of decisions made.
• Support development of an integrated process data map and criticality assessments for automation and manufacturing systems deliverables.
• Manage cost and resource allocation within your system(s) of responsibility, and support system installations, walkdowns, C&Q, and turnover activities during facility construction.
• Develop asset management procedures including preventive maintenance and calibration programs, and drive standards for production/laboratory equipment, facilities, and clean/GMP utilities.
• Oversee all stages of the asset lifecycle, from replacement planning and vendor selection to resolution of technical issues and execution of corrective actions.
• Participate in compliance inspections/audits and ensure adherence to cGMPs, regulatory requirements, safety and environmental regulations, SOPs, and company policies.
• Actively communicate with the Engineering community and share expertise across global CAR-T entities while analyzing processes for optimization, efficiency, and cost savings.
• Develop and maintain in-depth knowledge of CAR-T manufacturing processes, aseptic and cell processing techniques, cell processing robotics and automation, and relevant regulatory frameworks.

Required Qualifications

• Education: Minimum of a Bachelor's or equivalent University Degree required; advanced or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry, or a related field.
• Experience Required: Minimum 6 years of relevant work experience in manufacturing operations, laboratory operations, or an engineering environment within the pharmaceuticals or biopharmaceuticals industry.
• Hands-on experience in asset ownership (equipment, facilities, and utilities) and managing change including vendor management and change control.
• In-depth knowledge of current GMP standards and guidelines (e.g., ISO, EN, ICH, FDA, ISPE) related to equipment, utilities, and facilities commissioning and qualification.
• Ability to effectively prioritize tasks, manage shifting deadlines, and collaborate proactively in a matrix environment.
• Demonstrated startup mindset, clear communication skills, and an independent approach to handling multiple cross-functional issues.

Preferred Qualifications

• Experience with equipment/systems commissioning, qualification, or validation; familiarity with laboratory analytical instruments, process automation, IT manufacturing systems, and cell therapy (CAR-T) is a plus.

Benefits & Perks

• Salary: $100,000 - $172,500
• Benefits: Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, pension, 401(k), long-term incentive program, vacation, sick time, holiday pay, personal and family time, parental leave, condolence leave, caregiver leave, volunteer leave, and military spouse time-off.
• Schedule: Hybrid position
• Location: Titusville, New Jersey; Springhouse, Pennsylvania; Raritan, New Jersey