• Lead, mentor, and directly supervise sterility assurance engineers fostering a high‑performing, accountable, and collaborative team
• Serve as a hands‑on technical leader, providing day‑to‑day guidance and support during execution, troubleshooting, deviations, and investigations
• Establish and communicate a clear sterility assurance vision aligned with regulatory expectations and business objectives
• Manage timelines, priorities, and resource allocation across multiple sterility assurance, validation, and improvement initiatives
• Lead the development and execution of process, equipment, sterilization, and facility validation activities, including plans, protocols, and reports
• Provide technical leadership for EtO and gamma sterilization programs, ensuring ongoing compliance and sterility assurance
• Oversee the creation, maintenance, and execution of Validation Master Plans (VMPs) for facilities and critical processes
• Ensure process and equipment changes are evaluated and managed using risk‑based methodologies (e.g., FMEA) to protect sterility assurance and critical product quality attributes
• Lead investigations and resolution of sterility assurance‑related deviations in collaboration with quality, engineering, manufacturing, and regulatory partners
• Review and approve controlled documentation, including validation protocols and reports, Device Master Record (DMR) documentation, and nonconformance records

• Bachelor’s degree in Life Sciences or Engineering
• Certified Quality Engineer (CQE) or Professional Engineer (PE) certification preferred

Required Experience

• 8+ years of progressive experience in a medical device, biopharmaceutical, or other highly regulated manufacturing environment
• Experience in quality engineering and process validation activities
• Aseptic Process Simulation (APS) design and execution experience; oversight experience preferred
• Cleanroom design and/or operations experience preferred
• Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products, and active pharmaceutical ingredients
• Preferred: Validation experience in medical devices, drugs, and/or biologics

• Strong knowledge of sterility assurance principles, sterilization technologies, and contamination control
• Demonstrated expertise in risk assessment tools (e.g., FMEA, FTA) and quality improvement methodologies (e.g., DMAIC, process mapping, flowcharts)
• Proven ability to define, organize, prioritize, and lead complex technical work across cross‑functional teams
• Strong technical writing skills, including authoring and reviewing protocols, reports, and regulatory‑facing documentation
• Advanced critical thinking, root cause analysis, and technical investigation skills
• Ability to analyze, interpret, and present data and technical concepts to diverse audiences
• Strong facilitation, project management, and interpersonal communication skills