Senior Sterility Assurance Engineer

Lifecore Biomedical; Chaska (MN); Hybrid; USD 95,000 - 110,000; Full time

Benefits offered by this job

Hybrid schedule

Promotion opportunities

Competitive total rewards package

Wellness and health plans

Job summary

Lifecore Biomedical is seeking a Senior Sterility Assurance Engineer in Minnesota. The role involves defining and executing aseptic process simulations, cleaning validation, smoke studies, and secondary sterilization activities.

You will investigate failures and ensure validated processes remain robust, with leadership in validations and audits. The position offers a hybrid work schedule with on-site needs for meetings and audits.

Qualifications

• BS in Engineering or Life Sciences required.
• 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 is a plus.

Responsibilities

• Define, execute, review/approve and summarize Aseptic Process Simulations, Cleaning Validation, Smoke Studies, Secondary Sterilization activities, etc.
• Investigations into failures and root cause analysis.
• Monitor, support, and review changes to existing validated aseptic processes.
• Provide knowledge leadership and technical expertise for validations and investigations, and support audits.

Skills

Sterility Assurance

Quality Engineering

Aseptic Filling

Cleaning Validation

FMEA

Education

BS in Engineering or Life Sciences

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

As a Senior Sterility Assurance Engineer you will define, execute, review/approve and summarize Aseptic Process Simulations, Cleaning Validation, Smoke Studies, Secondary Sterilization activities (eg EtO), 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.

This position is eligible for 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’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
• Secondary sterilization
• Perform risk assessment (FMEA) on new/changed equipment and processes and procedures
• Provide knowledge leadership and technical expertise for validations and investigations
• Provide technical expertise in support of audits.

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

• 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!

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