Sr. Principal Process Engineer, Biologics Manufacturing

This is an exciting opportunity charged with the design, start-up, and long-term technical ownership of a state-of-the-art digitally enabled startup large-scale GMP biologics manufacturing facility. You will serve as the Process Engineering Expert for critical process and utility systems while driving the execution of strategic and key CAPEX manufacturing projects.

You will partner cross-functionally with Manufacturing, Quality, Automation, Facilities, and external design/construction firms to ensure “right first time” facility and equipment start-up, reducing risk, accelerating timelines, and ensuring GMP compliance. Your responsibilities will include:

• Leading advanced engineering design and start-up for a greenfield GMP manufacturing facility.
• Serving as Area System Owner for clean utilities and process systems including WFI, clean steam, plant steam, process gases, and chemical distribution systems.
• Providing integrated process equipment, utilities, and facility engineering expertise with strong operational and maintenance focus.
• Partnering with A&E firms, construction managers, and equipment vendors to develop and execute detailed project plans.
• Reviewing and approving P&IDs, ensuring adherence to ASME BPE and regulatory requirements.
• Supporting PLC/DCS automation-controlled systems integration and start-up.
• Driving risk assessments, technical tradeoff analysis, and mitigation strategies across multiple concurrent projects.
• Ensuring GMP compliance and readiness for validation and operational handover.
• Mentoring Engineers and fostering high-performance engineering culture.
• Supporting CAPA, Lean, and continuous improvement initiatives to enhance reliability and cost-effectiveness.

• 12+ years of process engineering experience within commercial GMP biologics or pharmaceutical manufacturing facilities.
• Process Engineering, Project Engineering or MSAT experience supporting the manufacturing of large molecule biologics including monoclonal antibodies or mammalian cell culture derived biologics.
• Track record leading successful CAPEX program execution and cross-functional teams.
• Proven experience supporting greenfield or brownfield facility start-ups, including utilities, automation, and facilities integration.
• Strong expertise in supporting clean utilities, ASME BPE standards, and GMP regulatory environments.
• Experience working with PLC/DCS automation system such as Emerson Delta
  
  V or Rockwell automation.
• Demonstrated ability to lead multiple large-scale projects simultaneously with the ability to synthesize technical, operational, and business requirements.
• BS in Chemical Engineering, Mechanical Engineering, Electrical Engineering or related Engineering field; MS, MBA, PhD, or PE certification a plus.
• Lean, Six Sigma, or related operational excellence certifications a plus.

This is a unique opportunity to join a leading U.S. biopharmaceutical company, supporting the establishment and start-up of a state-of-the-art digitally enabled commercial manufacturing facility and flagship capital project. The site will manufacture next-generation biologic therapies focused on oncology, immunology, and neurological diseases.