Sterility Assurance Engineering Manager

It’s not what we make, it’s what we make possible. And the possibilities at Lifecore are endless!This full-time position offers incredible benefits and a company culture focused on development and growth, including strong opportunities for learning, advancement, and career progression.Lifecore has a Sterility Assurance Engineering Manager opportunity based onsite in Chaska, Minnesota. 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.Technical and Team LeadershipLead, 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 initiativesLead 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 Required EducationBachelor’s degree in Life Sciences or EngineeringCertified Quality Engineer (CQE) or Professional Engineer (PE) certification preferred Required Experience8+ years of progressive experience in a medical device, biopharmaceutical, or other highly regulated manufacturing environmentExperience in quality engineering and process validation activitiesAseptic Process Simulation (APS) design and execution experience; oversight experience preferredCleanroom design and/or operations experience preferredComprehensive understanding of GMP regulations for medical devices, pharmaceutical products, and active pharmaceutical ingredientsPreferred: Validation experience in medical devices, drugs, and/or biologicsRequired CompetenciesStrong 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 skillsStarting Salary: $130,000 - $160,000 annually with consideration for relevant experienceLifecore offers a highly competitive total rewards package, including:Opportunities to learn and grow with a well-respected companyCompetitive compensation with annual reviews and a company-wide incentive bonusBenefits that start the first of the month after you join Lifecore as a full-time employee:3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution.Low-cost dental and vision insuranceShort term disability, long term disability and life insurance all 100% company paid4 weeks PTO in the first year (increases to 5 weeks after just 2 years!)9 paid company holidays plus 2 personal holidaysPaid family leaveTuition reimbursement401k plan with company matching contributionMeet Lifecore Biomedical, LLC:Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.