Senior Manager CQV

Johnson & Johnson•Spring House, PA

61d•Hybrid

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â Through our expertise in Innovative Medicine and MedTech, 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.â Learn more at https://www.jnj.com 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 the best talent, Senior Manager, CQV. 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, execution systems and utilities, this role is the key point of contact for all technical matters related to Commissioning, Qualification & Validation. The CAR-T (CQV) Lead is responsible for providing compliance expertise, using J&J standards, oversight, and development of internal as well as external partnerships at the site level and beyond, with a focus on Commissioning, Qualification, Re-qualification, and Validation within the JJIM CAR-T facilities. The Lead will provide day-to-day management of C&Q and requalification activities, and work closely with different teams, vendors, sites, and partners. In addition, they will create and sustain continuous procedural improvements to boost efficiency of C&Q activities. During Health Authority inspections and audits, they are the first point of contact for asset & facility qualification-related matters and serve a leading role to ensure successful outcomes. Daily, the CQV Lead partners with Operations, MSAT, Quality, and 3rd party partners, as well as Environment Health & Safety. The CQV Lead will partner closely with global E&PS and Quality to ensure validation strategies are aligned with J&J standards and meet operational requirements. You will own the development and execution of the Project Validation Master Plan (PVMP) and ensure on-time qualified system turnover to the end user. 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 8 years of relevant work experience.
Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry
Experience leading and executing commissioning and qualification activities
Experience with Health Authority Inspections as well as internal and external audits
In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, FAGG/FAMHP, 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 C&Q tasks, 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, Process Automation, IT manufacturing systems, cell therapy (CAR-T) is an asset
People leadership/management experience (direct or indirect reports)

Responsibilities

Ownership for the development and execution of the Project Validation Master Plan (PVMP)
Support the writing and approval of URSs (User Requirement Specifications) for facilities, equipment and systems.
Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment, execution systems, as well as facilities and utilities
Lead the writing and execution of Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities
In partnership with E&PS own Computer Systems Validation, including writing and driving CSV protocols, Functional Specification (FS), Design Specification (DS) plus Functional Acceptance Test (FAT) and Site Acceptance Test (SAT), Integration testing (IQ), and Functional testing (OQ)
Accountable for cost and resources within system(s) of responsibility
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
Leading role 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
Provide leadership and act as expert in the field C&Q
Maintain partnerships with contractors and vendors that execute C&Q, Re-qualification, and PQ activities
Establish and manage critical metrics and tracking tools across C&Q scope
Site requalification activities at the Quality Site Management Review (QSMR) level
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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