Senior Sterility Assurance Engineer

About the role

This full-time position offers a hybrid work schedule, with up to 2 to 3 remote workdays per week based on business needs. Employees are expected to work on-site as required for meetings, client visits, audits, and other responsibilities that benefit from in-person collaboration and support.

In this critical engineering role, you will define, execute, review/approve, and summarize Aseptic Process Simulations, Cleaning Validation, Smoke Studies, Secondary Sterilization activities (e.g., EtO), and investigations into failures. You will use quality engineering concepts to monitor, support, and critically review changes or issues to existing validated aseptic processes.

Responsibilities

• Create and coordinate execution of sterility assurance and aseptic process validation protocols including but not limited to:
  • Smoke studies
  • Media Fills
  • Steam sterilization
  • Secondary sterilization
  • Cleaning disinfectant efficacy
• Perform risk assessment (FMEA) on new/changed equipment, processes, and procedures.
• Provide knowledge leadership and technical expertise for validations and investigations.
• Provide technical expertise in support of audits.

Requirements

• BS in Engineering or Life Sciences.
• 5-8 years of Sterility Assurance or Quality Engineering experience.
• Experience with aseptic filling and cleaning validation.
• Background in pharmaceutical, biotechnology, and/or chemistry production (a strong plus).

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 hire:
  • 3 medical insurance plans to fit your needs and budget, including an HSA Plan with company contributions.
  • Low-cost dental and vision insurance.
  • Short-term disability, long-term disability, and life insurance (all 100% company-paid).
• 3 weeks PTO in the first year (increases to 4 weeks after 2 years).
• 9 paid company holidays plus 2 personal holidays.
• Paid family leave.
• Tuition reimbursement.
• 401k plan with company matching contribution.

Pay

Starting salary: $95,000 - $110,000 annually, with consideration for relevant skills and experience.

Schedule

• Your choice of a 4½ or 5-day work week.
• Hybrid schedule with up to 2-3 remote workdays per week.

About Lifecore Biomedical

Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) offering 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.