8+ years of experience in a regulated manufacturing environment
Experience in quality engineering and process validation activities
Aseptic Process Simulation (APS) design and execution experience preferred
Strong understanding of GMP regulations related to medical devices and pharmaceuticals
Responsibilities
Lead and mentor sterility assurance engineers to foster high performance
Provide hands-on technical leadership and support during troubleshooting and investigations
Establish and communicate a clear sterility assurance vision
Manage timelines and resources across multiple initiatives
Lead development and execution of validation activities for processes and equipment
Ensure ongoing compliance for EtO and gamma sterilization programs
Oversee Validation Master Plans for facilities and critical processes
Benefits
Medical insurance plans with HSA options and employer contributions
Dental and vision insurance
Company-paid short and long-term disability and life insurance
4 weeks PTO in the first year, increasing to 5 weeks after 2 years
9 paid company holidays and 2 personal holidays
Paid family leave
Tuition reimbursement
401k plan with company match
Full Job Description
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.
