Senior Principal Engineer, Sterile Fill

Responsibilities

• Serve as a global subject matter expert for aseptic manufacturing equipment and sterile processing technologies and provide technical leadership in the design, specification, and lifecycle management of aseptic equipment.
• Support global capital projects and manufacturing sites with expert guidance on aseptic processing technologies.
• Establish and maintain engineering standards and best practices for sterile manufacturing equipment and provide expert guidance to ensure equipment design and operational practices comply with EU GMP Annex 1: Manufacture of Sterile Medicinal Products.
• Support implementation of Contamination Control Strategies (CCS) across sterile manufacturing facilities by ensuring that equipment designs support robust sterility assurance principles including minimization of operator interventions, effective sterilization and decontamination processes.
• Lead technical evaluations and technology selection for aseptic manufacturing systems including Vial, syringe, and cartridge filling lines, isolators, Lyophilizers, autoclaves and sterilization systems, de-pyrogenation tunnels, CIP and SIP systems.
• Conduct vendor technical assessments and due diligence.
• Develop global equipment standards and technology roadmap and provide input to capital investment planning for sterile manufacturing technologies.
• Provide technical oversight during equipment design, procurement, and integration.
• Review vendor designs to ensure compliance with specifications and standards.
• Provide technical leadership during commissioning, qualification, and startup of aseptic equipment.
• Review and approve equipment commissioning and qualification documentation including: FAT and SAT protocols, Commissioning plans, Installation Qualification (IQ) and Operational Qualification (OQ), support performance qualification readiness and GMP startup activities.
• Provide expert troubleshooting support for complex aseptic equipment and sterile manufacturing systems.
• Lead root cause investigations related to equipment performance issues, sterility risks, and contamination events.
• Support corrective and preventive action (CAPA) development and implementation.
• Provide technical support during critical production or startup events.
• Develop best practice guidance and technical standards for global engineering teams.
• Provide training and technical mentorship to engineering and manufacturing teams.
• Ensure consistency of engineering approaches across projects and sites.
• Foster a culture of safety, accountability, collaboration, and operational excellence.

  Qualifications

  • BS, Engineering or equivalent technical degree; Masters degree in Engineering preferred
  • 10+ years of experience as a technical subject matter expert in aseptic and sterile fill operations
  • Proven leadership experience in delivery of fill and finish projects from concept to qualification
  • Deep knowledge of engineering systems in a drug product facility
  • Familiarity with industry leaders in fill and finish equipment such as B&S, Syntegon, Groninger, Optima, Skan, EMADemonstrated experience managing Engineering contractors and global equipment vendors
  • Results-oriented leadership with outstanding negotiation skills and risk-based decision making is required
  • Ability to mentor and develop next generation of leaders