Senior Sterility Assurance Engineer

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

Benefits offered by this job

Healthcare plans

HSA with company contributions

Dental & vision insurance

3 weeks PTO

9 company holidays + 2 personal days

Job summary

Lifecore Biomedical, Inc. is seeking a Senior Sterility Assurance Engineer in Chaska, MN. This role focuses on defining and executing aseptic process simulations, validation protocols, and related studies to ensure sterile product quality.

Hybrid work is offered with some on-site requirements for audits and collaboration. Ideal candidates have a BS in engineering or life sciences with 5–8 years in sterility or quality engineering, and experience in aseptic filling and cleaning validation within

Qualifications

• 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 production is a strong plus.

Responsibilities

• Define, execute, review/approve and summarize aseptic process simulations and validation protocols.
• Conduct smoke studies, cleaning validation, media fills, steam/secondary sterilization activities.
• Perform investigations into failures and provide technical leadership for validations.
• Support audits and provide expertise for quality improvements.

Skills

Sterility Assurance

Project management

Cross-functional collaboration

Education

BS in Engineering or Life Sciences

Tools

Aseptic filling

Cleaning validation

FMEA

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Sterility Assurance Engineer

Regular Full-Time Professionals Chaska, MN, US

8 days ago Requisition ID: 1536

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 willdefine, 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
  • Steam sterilization
  • Secondary sterilization
  • Cleaning disinfectant efficacy
• 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
  • Tuition reimbursement
  • 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.