Sr. Principal Engineer, Equipment Preparation Lead
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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. As part of the Global Process Engineering team, the Sr. Principal Engineer, Equipment Preparation Lead, is the technical, subject matter (SME) expert in the equipment preparation area (parts prep, autoclaves, parts washers, COP/SOP, filter integrity testing). They will be accountable for overall E2E process engineering leadership in the design and execution of the equipment preparation area for 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; MS or MBA preferred.
- A minimum of 10 years experience in process engineering or capital project execution of equipment preparation equipment – autoclaves, parts washers, filter integrity testing, COP (clean-out-of-place), SOP (steam-out-of-place), equipment disassembly and assembly.
- 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 equipment preparation equipment (autoclaves, parts washers, filter integrity test stations, COP/SOP stations)
- 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 aseptic processing equipment including autoclaves, parts washers, filter integrity units, and COP/SOP systems
- Capital project leadership of aseptic manufacturing equipment, green or brown field GMP manufacturing facility start-up, in the range of $100 - $500 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 the equipment preparation area 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 equipment preparation area collaborating with a diverse multi-functional team including strategic equipment vendors
- 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
