Sterility Assurance Engineer

Sterility Assurance Engineer

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

This individual will be responsible for support of the environmental/personnel monitoring programs, creation/review/approval and summarization of EMPQs, Aseptic Process Simulations, Cleaning Validation, etc. including investigations into failures; as well as additional support of aseptic technique and gowning in cross functional teams for both new and legacy processes. They will use quality engineering concepts to monitor, support, and critically review changes or issues to existing validated aseptic processes.

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

In this critical engineering role you'll have the opportunity to:

• Create and coordinate execution of sterility assurance and aseptic process validation protocols including but not limited to:
  • Smoke studies
  • Media fills
  • Environmental Monitoring PQs
• Perform/support risk assessment (FMEA) on new/changed equipment and processes and procedures

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
• 2-5 years of experience in a quality function, Sterility Assurance experience preferred
• Background in environmental/personnel monitoring, aseptic processing, and cleaning validation
• Experience with aseptic filling, specifically isolator technology beneficial
• Background in pharmaceutical, biotechnology and/or chemistry production a strong plus!

Lifecore is a growing company and 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 of PTO in the first year (increases to 5 weeks after just 2 years!)
  • 9 paid company holidays (plus your birthday!)
  • 4 weeks of paid family leave after 1 year of employment
  • Tuition reimbursement
  • 401k plan with company matching contribution

Meet Lifecore Biomedical, LLC:

For more than 30 years, we've made progress possible for patients around the world and for our employees here in Minnesota. As the global leader in manufacturing and supplying sodium hyaluronate (NaHy), more than 90 million patients have benefitted from our certified pharmaceutical grade NaHy. We are guided by an unwavering commitment to improving people's lives, including those who work at Lifecore.