Senior Sterility Assurance Engineer
Lifecore Biomedical Inc
Summary
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.
Job description
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!
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
- Medical insurance
- HSA plan
- Dental insurance
- Vision insurance
- Short term disability
- Long term disability
- Life insurance
- Paid time off
- Paid company holidays
- Personal holidays
- Paid family leave
- Tuition reimbursement
- 401(k) matching
- Incentive bonus
Company overview
Lifecore Biomedical Inc is a leading U.S.-based contract development and manufacturing organization (CDMO) specializing in sterile injectable pharmaceuticals. Founded in 1965 and headquartered in Chaska, Minnesota, the company has established itself as a premier provider of end-to-end sterile injectable solutions for pharmaceutical and biotechnology companies. With over 40 years of expertise in pharmaceutical-grade sodium hyaluronate production, Lifecore offers comprehensive services spanning formulation development, process optimization, aseptic filling, and final packaging of complex injectable therapies. The company's capabilities include handling highly viscous solutions, sterile filtration, and manufacturing challenging drug products that require specialized expertise. Lifecore operates with a strong focus on quality and compliance, maintaining international certifications while supporting more than 25 commercial products globally. As a publicly traded company on Nasdaq under ticker LFCR, Lifecore continues to expand its role as a trusted partner in bringing innovative injectable treatments to patients worldwide.