Sterility Assurance Engineering Manager

Lifecore Biomedical; Chaska (MN); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

4 weeks PTO first year

401k with company matching

Health insurance plans

Paid family leave

Job summary

Lifecore Biomedical, LLC in Chaska, Minnesota, is hiring a Sterility Assurance Engineering Manager onsite to lead a cross-functional team and drive validated, compliant sterilization programs across EtO, gamma, and related processes.

You will oversee VMPs, risk-based change control, investigations, and continuous improvement, partnering with quality, engineering, and regulatory teams to ensure product integrity and regulatory readiness.

Qualifications

• Bachelor's degree in Life Sciences or Engineering.
• 8+ years in a medical device/regulated manufacturing environment.
• Experience in quality engineering and process validation activities.
• Aseptic Process Simulation (APS) design and execution; oversight preferred.
• GMP knowledge for medical devices/pharmaceuticals; sterile processes.

Responsibilities

• Lead sterility assurance engineers; mentor and supervise.
• Provide hands-on technical leadership during execution, deviations, and investigations.
• Define sterility assurance vision aligned with regulatory expectations.
• Manage timelines, priorities, and resources across sterility programs.
• Lead development and execution of validation activities (process, equipment, sterilization, facility).
• Oversee VMPs for facilities and critical processes; ensure risk-based changes.

Skills

Sterility assurance

Technical leadership

Project management

Data interpretation

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or Engineering

Job description

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 Leadership

• 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

Required Education

• Bachelor’s degree in Life Sciences or Engineering

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

Starting Salary: $130,000 - $160,000 annually with consideration for relevant experience

Lifecore offers a highly competitive total rewards package, including:

• Opportunities to learn and grow with a well-respected company
• Competitive compensation with annual reviews and a company-wide incentive bonus
• Benefits 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 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
• 401k plan with company matching contribution

Meet 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.