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

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.