Sterility Assurance Engineering Manager

Lifecore Biomedical Inc•Chaska, MN

4h•Onsite

About The Position

As a key technical leader, this position partners closely with cross-functional stakeholders to ensure sterility assurance processes are scientifically sound, robust, scalable, and compliant with regulatory and quality standards. This role provides both technical and people leadership to support current operations and future growth, with accountability for sterility assurance strategy, execution, and continuous improvement.

Requirements

Bachelor’s degree in Life Sciences or Engineering
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
Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products, and active pharmaceutical ingredients
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

Nice To Haves

Certified Quality Engineer (CQE) or Professional Engineer (PE) certification preferred
Aseptic Process Simulation (APS) oversight experience preferred
Cleanroom design and/or operations experience preferred
Validation experience in medical devices, drugs, and/or biologics

Responsibilities

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

Benefits

Opportunities to learn and grow with a well-respected company
Competitive compensation with annual reviews and a company-wide incentive bonus
3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution.
Low-cost dental and vision insurance
Short term disability, long term disability and life insurance all 100% company paid
4 weeks PTO in the first year (increases to 5 weeks after just 2 years!)
9 paid company holidays plus 2 personal holidays
Paid family leave
Tuition reimbursement
401k plan with company matching contribution