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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:
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Ready to lead at the forefront of aseptic filling innovation? Learn more and apply today!
As a part of the Global Process Engineering team, the ** Sr. Princ. Process Eng – DP Aseptic Biotherapeutic Filling Equipment ** will serve as a recognized technical leader and SME, playing a pivotal role in shaping the future of aseptic drug product manufacturing. This role owns end‑to‑end process engineering leadership for the design, implementation, and start‑up of state‑of‑the‑art aseptic filling line systems (vial and syringe) within a new cGMP manufacturing facility.
Using deep scientific, engineering, and business expertise, this leader will drive the development and optimization of filling system equipment, solve complex technical challenges, and guide systems from concept through commissioning, qualification, and successful line start‑up. The role offers the opportunity to influence critical technical decisions, partner closely with cross‑functional teams and vendors, and ensure the delivery of compliant, high‑performing filling systems that meet global regulatory expectations and support long‑term business success.
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 on 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.
**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