Johnson & Johnson Innovative Medicine · 1 day ago
Sr. Principal Engineer, Process System Owner – Filling Systems
Wilson, NC
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to advancing health through innovative medicine. The Sr. Principal Engineer, Process System Owner – Filling Systems will be responsible for leading the design and execution of new filling line systems in a cGMP drug product manufacturing plant, ensuring compliance with regulatory standards and optimizing processes.
Pharmaceuticals
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
Qualification
Required
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
Preferred
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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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