Sterility Assurance Engineering Manager

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 Quality Engineering Manager opportunity based onsite in Chaska, Minnesota.

As a key technical leader, this position is responsible for developing, establishing and maintaining quality engineering and sterility assurance programs, policies, processes, procedures, and controls ensuring that the quality and sterility of components, raw materials and Lifecore manufactured clinical stage products conform to established requirements, standards, and regulatory requirements.

Technical and Team Leadership

• Lead Quality Engineering team supporting the quality system and clinical stage production processes, responsible for:

• Ensuring the design of production processes is sufficient to consistently attain a predefined quality at the end of the manufacturing process.

• Ensuring that critical process parameters and adequate specifications are defined as appropriate for the product lifecycle phase.

• Development and execution of process, equipment, sterilization and facility validation plans, protocols and reports.

• Approval or rejection of raw materials, components, labeling, in-process and finished goods.

• Review of production records and assurance of data integrity.

• Ensuring that any errors that occur during production are fully investigated.

• Approval or rejection of products manufactured, processed, packed, or held under contract at any other company.

• Approval or rejection of procedures or specifications impacting the identity, strength, quality, and purity of product.

• Risk management of production and quality system processes:

• Approval or rejection of process and/or design changes.

• Validation of equipment and/or processes as required.

• Review and resource new business activities and improvement projects.

• Support internal and external audit activities.

• Oversee creation of validation master plans for product, facility and critical processes, as well as the associated validation activity.

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, sterility assurance, and validation
• Experience leading technical teams
• Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients.

Required Competencies

• Excellent organizational skills; capable of managing multiple dynamic, cross-functional projects simultaneously.
• Ability to provide effective technical and personnel leadership to ensure team accountabilities are completed in a timely and satisfactory manner.
• Proven ability to effectively define, organize, lead and prioritize workload.
• Strong understanding of risk management and associated tools (FMEA, FTA, etc.).
• Experience in use of Quality Improvement tools (ex. flowcharts, DMAIC, process mapping, etc.).
• Demonstrated problem solving skills and the ability to train and develop others.
• Established effective technical writing and oral communication skills.
• Proven ability to envision and implement quality improvements.
• Ability to effectively analyze and present data and concepts to a broad audience.

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.