Sterility Assurance Engineering Manager

About the role

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.

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
• Evaluate and manage process and equipment changes 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

Requirements

• Required Education: 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

Qualifications

• 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)
• Prominent ability to define, organize, prioritize, and lead complex technical work across cross-functional teams
• Advanced critical thinking, root cause analysis, and technical investigation skills
• Proven ability to analyze, interpret, and present data and technical concepts to diverse audiences
• Strong facilitation, project management, and interpersonal communication skills

Skills

• Strong technical writing skills, including authoring and reviewing protocols, reports, and regulatory-facing documentation

Benefits

• 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
• Tuition reimbursement
• 401k plan with company matching contribution

Pay

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

Schedule

Full-time

Contact

Lifecore Biomedical, LLC