Associate Sterility Assurance Engineer chez Lifecore Biomedical, Inc.

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, your choice of a 4, 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.

As an Associate Sterility Assurance Engineer provide validation support for EMPQs, Aseptic Process Simulations, Cleaning Validation, etc. including investigations into failures. You will use quality engineering concepts to monitor, support, and critically review changes or issues to existing validated aseptic processes with mentorship from Subject Matter Experts.  

This is a hybrid role, with the option to work in the office or remotely depending on your day’s schedule.

In this entry level engineering role you’ll have the opportunity to:

• Assist in the creation and  execution of sterility assurance and aseptic process validation protocols including but not limited to:
  • Smoke studies
  • Media fills
  • Environmental Monitoring PQs
  • Product sterilization (Autoclave, EtO, Gamma, E-beam)
• Assist in the creation and execution of protocols in support of new and existing controlled area (cleanroom) qualification.
• Provide technical consultation for validations and investigations.

This position could be a great fit for you if you have excellent organizational ability, the capability to manage multiple, dynamic cross functional projects simultaneously. along with the following:

• BS in Engineering or Life Sciences 
• Up to 2 years of experience in a quality function, sterility assurance experience preferred
• Background in at least one of the following: environmental/personnel monitoring, aseptic processing, or cleaning validation
• Experience supporting multiple teams and/or projects at once.
• Experience in risk assessment (FMEA, FTA, etc.).
• Experience in use of Quality Improvement tools (ex. flowcharts, DMAIC, process mapping, etc.).
• Background in pharmaceutical, biotechnology, chemistry production, and/or microbiology a plus! 

Starting Salary: $68,000 - $78,000

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
  • 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)
  • 9 paid company holidays plus 1-2 personal holidays
  • 4 weeks of paid family leave after 1 year of employment
  • Tuition reimbursement
  • 401k plan with company matching contribution
  • Annual bonus based on company performance

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.