Sr. Princ. Process Engineer – DP Aseptic Biotherapeutic Filling Equipment

Key Responsibilities

• Lead the development and delivery of aseptic filling line system documentation, including User Requirements Specifications (URS), equipment data sheets, technical specifications, P&IDs, and process flow diagrams (PFDs).
• Evaluate and select equipment vendors by assessing technical capability, reviewing bid packages, and leading technical discussions; maintain accountability for filling system performance through project execution.
• Lead the detailed design and engineering of aseptic filling line equipment (e.g., E-Beam, isolators, vial and syringe filling lines) in close collaboration with equipment suppliers and cross-functional stakeholders.
• Own the layout, design, and integration of the filling line within the facility, ensuring alignment with aseptic processing, Annex 1 requirements, and operational needs.
• Serve as the technical lead for FAT, SAT, (C&Q), and start-up of aseptic filling systems.
• Lead technical issue investigation and resolution during C&Q and start-up, ensuring systems are fully ready to enter qualification and routine operation.
• Drive coordination and execution across multiple functions—Manufacturing, Facilities, MSAT, Quality, Procurement, Engineering & Property Services (E&PS), and EHS—to remove barriers and maintain project momentum.
• Provide strong technical leadership and partner management, ensuring alignment across evolving business, quality, and regulatory expectations.
• Stay ahead of industry trends, regulatory changes, and external guidelines, benchmarking internal designs and approaches against leading standards.
• Apply data-driven insights and market intelligence to inform technical decisions, optimize system performance, and support long-term portfolio and facility strategy.
• Ensure all work follows company policies, cGMP requirements, global regulatory standards, and customer specifications.

Qualifications

Education: Minimum of a Bachelor's Degree in engineering required (Mechanical Engineering preferred), MS or MBA preferred.

Experience and Skills

Required:

• Minimum of 10 years of process engineering and/or capital project execution experience supporting aseptic filling systems for large-molecule biotherapeutic drug products (vials and/or prefilled syringes) in a cGMP drug product manufacturing environment.
• Demonstrated experience as a technical lead or subject matter expert (SME) for aseptic filling operations for sterile injectable biologics (e.g., monoclonal antibodies, recombinant proteins, vaccines).
• Hands-on experience leading the design, installation, commissioning, qualification (C&Q), and start-up of aseptic filling line systems, including isolator-based filling technologies.
• Deep understanding of global aseptic manufacturing regulations, including FDA cGMPs and EU Annex 1, and their impact on facility, equipment, and process design.
• Shown ability to lead and collaborate across cross-functional teams (Manufacturing, MSAT, Quality, Facilities, EHS, Procurement, Engineering & Property Services) in a matrixed environment.
• Extensive experience working with external partners (A&E firms, construction contractors, and equipment vendors) to develop, execute, and deliver complex capital projects.
• Strong technical problem-solving skills, with the ability to resolve sophisticated process, equipment, and regulatory challenges during project execution and C&Q.
• Solid understanding of: Aseptic processing and contamination control strategies; Commissioning & Qualification methodologies; Engineering design principles for biotherapeutic drug product facilities; Construction and procurement processes; Project controls and project scheduling; EHS requirements, including EHS-by-design and construction safety.
• Excellent communication, leadership, and decision-making skills, with the ability to influence stakeholders and drive alignment in a fast-paced, evolving business environment.
• Strong passion for technical excellence and continuous improvement, with the ability to drive innovation in aseptic filling equipment and facilities.

Preferred:

• Consistent track record leading large-scale capital projects for aseptic filling systems with total project values in the range of $50M–$100M.
• Experience supporting greenfield and/or brownfield GMP drug product manufacturing facility start-ups.
• Experience transitioning filling systems from conceptual design through operational readiness in a commercial biotherapeutic environment.

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.