Sr. Principal Engineer, Equipment Preparation Lead

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 Med Tech, 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.

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• Job Function:
  Supply Chain Engineering
• Job Sub Function:
  Process Engineering
• Job Category:
  Scientific/Technology
• All Job Posting Locations:
  Wilson, North Carolina, United States of America

Job Description:

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

• 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.

• Minimum of a Bachelor's Degree in engineering required; MS or MBA preferred.
• Required:
  
  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 &…