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

Johnson & Johnson Innovative Medicine•Wilson, NC

5d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Consistent track record on leading capital projects for biotherapeutic aseptic DP compounding equipment and automating compounding equipment in the range of $30 - $50 MM$
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

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