Principal QC Labs Engineer

Johnson & Johnson•Raritan, NJ

48d•Hybrid

About The Position

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine. 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. #LI-Hybrid 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 the key point of contact for technical matters related to QC laboratory and instrumentation systems. The CAR-T QC Labs Engineer 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 execution during project design, qualification, startup and transition to operations and asset replacement projects, and will closely collaborate with the different project organizations, vendors, sites, and partners. In addition, the Engineer will create and sustain continuous technical improvements around our asset base and supports problem solving as needed. Daily, the Engineer partners with Analytical R&D, Operations, MSAT, Quality, and 3rd party partners, as well as Environment Health & Safety. The Principal CAR-T QC Labs Engineer will act as a decision maker in the Engineering workstream and partner with Analytical R&D, E&PS, Operations and Quality to ensure facility and equipment design meet operational requirements. You will manage and drive engineering systems through Engineering, Procurement, and Construction Phases to ensure on-time system delivery. 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. Furthermore, a portion of your time will be focused on developing detailed knowledge of CAR-T production processes:

Requirements

Minimum of a Bachelor's or equivalent University Degree required; advanced degree or focused 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 within 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 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.

Nice To Haves

Experience with equipment / systems commissioning/qualification/validation, Laboratory Analytical Instruments, Process Automation, IT manufacturing systems, cell therapy (CAR-T).

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.
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 lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility
Participate and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.)
Support development of integrated process data map and criticality assessments for use in automation and manufacturing systems deliverables.
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.
Develop asset management procedures, PM, maintenance and calibration
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.
Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
Develop & maintain robust understanding of aseptic and cell processing techniques.
Develop & maintain an in-depth knowledge of cell processing robotics and automation.
Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours

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