Sr. Principal Engineer, Aseptic DP Compounding Owner – Aseptic DP Compounding

What the role needs

• Wilson, North Carolina, United States of America Job Description:
• 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 two aseptic DP compounding suites and processes/equipment and recipe development, 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
• A minimum of 10 years experience in aseptic drug product compounding in a biotherapeutics cGMP environment (preferably in process engineering or capital project execution)
• Track record of developing and maintaining strong partnerships with key stakeholders

From the employer

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. 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. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Apply today for this exciting opportunity to be part of our growing team! As part of the Global Process Engineering team, the Sr. Principal Engineer, Process Engineering System Owner – Aseptic DP Compounding is the technical subject matter (SME) expert in aseptic, biotherapeutic drug product compounding (single-use technology, stainless steel tank design, tank cleaning and sterilization, mixing, and filtration). They will be accountable for overall E2E process engineering leadership in the design and execution of implementing the compounding areas for aseptic, biotherapeutic drug products. They will be responsible for demonstrating their scientific, technical, and business expertise to develop the process/equipment, solve sophisticated equipment issues, optimize the process, lead commissioning and qualification activities and line start-up and ensure full compliance to regulatory standards. Key Responsibilities: • Development and delivery of aseptic, biotherapeutic, drug product compounding equipment (single-use mixers, stainless steel tanks, COP – Clean-Out-Of-Place skids, SOP – Sterilize Out of Place skids, mixing, and filter integrity testing) specifications and drawings, including user requirements, data sheets, technical specifications, P&ID’s, and 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 two aseptic DP compounding suites and processes/equipment and recipe development, 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 Qualifications Education: • Minimum of a Bachelor's Degree in engineering required (Chemical Engineering preferred), MS or MBA preferred. Experience and Skills: Required: • A minimum of 10 years experience in aseptic drug product compounding in a biotherapeutics cGMP environment (preferably in process engineering or capital project execution) • Track record of developing and maintaining strong partnerships with key stakeholders • Experience designing and implementing single-use technology (single-use mixers, single-use product path) • Experience designing stainless steel tanks and developing cleaning and sterilization recipes for stainless steel tanks • Ability to lead and motivate multicultural teams and remote customers • Extensive interaction with external partners (engineering firms, construction firms, equipment vendors) to develop, organize, and execute project plans as the aseptic DP biotherapeutic compounding 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 biotherapeutics DP aseptic compounding • EHS requirements, with particular focus on EHS by design and construction safety • Single-use technology design (mixers and product fluid path) • Start-up processes and Commissioning & Qualification of compounding 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 biotherapeutic aseptic DP compounding equipment and automating compounding equipment in the range of $30 - $50 MM$ (preferred) • Strong process engineering expertise in conceptual design through C&Q (commissioning & qualification) to ensure efficient operational readiness within an aseptic biotherapeutic drug product environment • Experience in green or brown field GMP manufacturing facility start-up Other: • This position will be located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson, NC. • For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .] Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Technical Research