Sr. Principal Engineer, Clean Utilities

Johnson & Johnson Innovative Medicine•Wilson, NC

7d•Onsite

About The Position

As part of the Global Process Engineering team, the Sr. Principal Engineer, Clean Utilities, is the technical, subject matter expert (SME) in clean utilities. They will be accountable for overall E2E process engineering leadership in the design and execution of implementing a clean utilities system into a new cGMP drug product manufacturing plant. They will be responsible for leveraging their scientific, technical, and business expertise to develop the equipment, solve sophisticated equipment 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 clean utilities design, operation, and maintenance within a pharmaceutical, biotechnology, or advanced therapy manufacturing facility (Water for Injection (WFI), clean steam generation, compressed air, and process gases).
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 (engineering design firms, construction firms, equipment vendors) to develop, organize, and execute project plans as Clean Utilities SME (subject matter expert)
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 clean utility systems (WFI, clean steam, compressed air, process gases)
EHS requirements, with particular focus on EHS by design and construction safety
Start-up processes and Commissioning & Qualification of clean utility systems within a pharmaceutical, biotechnology, or advanced therapies facility
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 in the area of clean utilities within the range of $50 - $200 MM$ (preferred)
Strong process engineering expertise in conceptual design through C&Q (commissioning & qualification) to ensure efficient operational readiness within a biotherapeutic drug product environment in the area of clean utilities

Responsibilities

Development and delivery of clean utility 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 clean utility equipment collaborating with a diverse multi-functional team including strategic equipment vendors
Lead the design of the CUP (clean utility plant) 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