Sterility Assurance Engineering Manager
$130,000–$160,000 year
On-site · Chaska, Minnesota, United States
Job Summary
Sterility Assurance Engineering Manager leading the sterility assurance function onsite in Chaska, MN. Drive technical leadership and people management for sterility assurance activities, oversee validation of processes, equipment, sterilization programs (EtO and gamma), and Development and execution of Validation Master Plans. Guide cross-functional teams through investigations, deviations, and regulatory/quality compliance, while delivering risk-based improvements to protect product quality. Responsible for defining sterility assurance vision aligned with regulatory expectations and business objectives, managing timelines and resources, reviewing control documents and regulatory-facing documentation, and mentoring engineers to build a high-performing team.
Required Qualifications
- Bachelor’s degree in Life Sciences or Engineering
- Certified Quality Engineer (CQE) or Professional Engineer (PE) certification preferred
- 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
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