Sr. Principal Engineer, Process System Owner – Filling Systems
About The Position
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 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. Learn more at https://www.jnj.com/innovative-medicine Learn more and apply to this exciting new role! As part of the Global Process Engineering team, the Sr. Principal Engineer, Process System Owner – Filling Systems, is the technical expert in aseptic filling. They will be accountable for overall E2E process engineering leadership in the design and execution of implementing new filling line systems (both vial and syringe) into a new cGMP drug product manufacturing plant. They will be responsible for leveraging their scientific, technical, and business expertise to develop the system equipment, solve sophisticated technical issues, optimize the process, lead commissioning and qualification activities and line start-up and ensure full compliance to regulatory standards.
Requirements
- Minimum of a Bachelor's Degree in engineering required (Mechanical Engineering preferred), MS or MBA preferred.
- A minimum of 10 years experience in process engineering or capital project execution of filling line systems in a biotherapeutics cGMP environment
- Track record of developing and maintaining strong partnerships with key stakeholders
- Ability to lead and motivate multicultural teams and remote customers
- Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize, and execute project plans as filling system SME
- Excellent problem-solving skills when handling potential conflicts
- Understanding sophisticated technical/regulatory issues impacting facility/equipment design
- Solid understanding of the following: cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design
- EHS requirements, with particular focus on EHS by design and construction safety
- Start-up processes and Commissioning & Qualification of filling line system equipment
- Principles for engineering design for drug products in the Biotherapeutic industry
- Construction & Procurement process
- Project Controls processes
- Project scheduling
- Strong technical process engineering knowledge and experience and has a great passion for solving highly complex technical problems
- Strong problem solving, communication, and decision-making skills to drive impact in a fast-paced evolving business landscape
- Ability to drive process engineering innovation for equipment and facilities ensuring technical knowledge is maintained and expanded throughout the team
Nice To Haves
- Consistent track record on leading capital projects for filling systems in the range of $50 - $100 MM$
- Strong process engineering expertise in conceptual design through C&Q (commissioning & qualification) to ensure efficient operational readiness within a biotherapeutic drug product environment in filling systems
- Experience in green or brown field GMP manufacturing facility start-up
Responsibilities
- Development and delivery of filling line system specifications and drawings (user requirements, data sheets, technical specifications, P&IDs, PFDs)
- Assess vendor competency and capabilities, review and discuss bid documents, and be held accountable for project development and execution, including performance of the process systems
- Lead the detailed design and development of the filling line system equipment (E-Beam, isolator, filling line) collaborating with a diverse multi-functional team including strategic equipment vendors
- Lead the design of the filling lines facility area
- Lead equipment FAT, SAT, C&Q, and start-up
- Technical issue resolution on the system during C&Q testing and the readiness of the system to start C&Q activities
- Helping to identify and expedite key activities across multiple business functions (Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS (Engineering & Property Services), and EHS
- Ensure alignment across evolving business needs and require strong partner management and leadership skills to collaborate across these multiple business partners
- Maintain a solid understanding of industry trends and benchmarking against internal/external practices
- Apply data-driven insights and market intelligence to advise future decision making, stay informed on industry and regulatory trends, and adapt strategies accordingly to achieve excellent portfolio performance
- Ensure compliance with policies, procedures, government regulations, and customer specifications
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
