Top 7230 Biomedical science Jobs

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Sterility Assurance Engineering Manager

Lifecore Biomedical Inc -
Chaska, MN

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Job Details

Full-time
$130,000 - $160,000 a year

Benefits

Health savings account
Paid holidays
Disability insurance
Dental insurance
Tuition reimbursement
Paid time off
Family leave
Vision insurance
401(k) matching
Opportunities for advancement
Life insurance

Qualifications

Content creation for technical audiences
Defect resolution root cause analysis
Technical documentation
Contamination control
Technical writing experience within manufacturing
Process design
Production risk assessment
Engineering process optimization
GMP
Cleanroom protocols
Project management experience in manufacturing
Manufacturing facility experience
Managing engineering teams
Production validation processes
Medical device manufacturing facility experience
Quality control documentation
Compliance documentation
Sterile processing regulatory compliance
Data interpretation
Leading team collaboration initiatives
Quality standards in production
Sterile products production
Regulatory compliance analysis
Quality improvement programs in engineering
Failure analysis
Pharmaceutical manufacturing facility experience

Full 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 and a company culture focused on development and growth, including strong opportunities for learning, advancement, and career progression.

Lifecore has a Sterility Assurance Engineering Manager opportunity based onsite in Chaska, Minnesota.

As a key technical leader, this position partners closely with cross‑functional stakeholders to ensure sterility assurance processes are scientifically sound, robust, scalable, and compliant with regulatory and quality standards. This role provides both technical and people leadership to support current operations and future growth, with accountability for sterility assurance strategy, execution, and continuous improvement.

Technical and Team Leadership

Lead, mentor, and directly supervise sterility assurance engineers fostering a high‑performing, accountable, and collaborative team
Serve as a hands‑on technical leader, providing day‑to‑day guidance and support during execution, troubleshooting, deviations, and investigations
Establish and communicate a clear sterility assurance vision aligned with regulatory expectations and business objectives
Manage timelines, priorities, and resource allocation across multiple sterility assurance, validation, and improvement initiatives
Lead the development and execution of process, equipment, sterilization, and facility validation activities, including plans, protocols, and reports
Provide technical leadership for EtO and gamma sterilization programs, ensuring ongoing compliance and sterility assurance
Oversee the creation, maintenance, and execution of Validation Master Plans (VMPs) for facilities and critical processes
Ensure process and equipment changes are evaluated and managed using risk‑based methodologies (e.g., FMEA) to protect sterility assurance and critical product quality attributes
Lead investigations and resolution of sterility assurance‑related deviations in collaboration with quality, engineering, manufacturing, and regulatory partners
Review and approve controlled documentation, including validation protocols and reports, Device Master Record (DMR) documentation, and nonconformance records

Required Education

Bachelor’s degree in Life Sciences or Engineering
Certified Quality Engineer (CQE) or Professional Engineer (PE) certification preferred

Required Experience

8+ years of progressive experience in a medical device, biopharmaceutical, or other highly regulated manufacturing environment
Experience in quality engineering and process validation activities
Aseptic Process Simulation (APS) design and execution experience; oversight experience preferred
Cleanroom design and/or operations experience preferred
Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products, and active pharmaceutical ingredients
Preferred: Validation experience in medical devices, drugs, and/or biologics

Required Competencies

Strong knowledge of sterility assurance principles, sterilization technologies, and contamination control
Demonstrated expertise in risk assessment tools (e.g., FMEA, FTA) and quality improvement methodologies (e.g., DMAIC, process mapping, flowcharts)
Proven ability to define, organize, prioritize, and lead complex technical work across cross‑functional teams
Strong technical writing skills, including authoring and reviewing protocols, reports, and regulatory‑facing documentation
Advanced critical thinking, root cause analysis, and technical investigation skills
Ability to analyze, interpret, and present data and technical concepts to diverse audiences
Strong facilitation, project management, and interpersonal communication skills

Starting Salary: $130,000 - $160,000 annually with consideration for relevant 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 a generous company contribution.
- Low-cost dental and vision insurance
- Short term disability, long term disability and life insurance all 100% company paid
- 4 weeks PTO in the first year (increases to 5 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.

Apply Now

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