Senior Design Quality Engineer
Lifecore Biomedical Inc
Summary
We are seeking a Senior Design Quality Engineer to join our MS&T team. In this role, you will provide quality engineering leadership and expertise to technical development programs, new business programs, and customer-facing product development activities. This role partners closely with cross-functional teams and customers to ensure quality is embedded throughout the product development lifecycle through the application of Quality by Design (QbD) principles and Design of Experiments (DOE). You will support the identification of quality, regulatory, and validation requirements early in development to facilitate robust product and process design while effectively meeting customer and business objectives.
Job description
In this critical engineering role, you will:
- Maintain knowledge of best industry practices to provide quality oversight and related initiatives for process development.
- Ensure validation strategies for clinical and commercial products are developed and executed in compliance with regulatory requirements, supporting robust processes and consistent product quality.
- Ensure development programs comply with the Quality System and all Design Control requirements.
- Use quality engineering concepts to monitor, support and critically review process development efforts.
- Review and approve experimental plans, development processes, equipment/process qualification and controlled documentation.
- Mentor good experimental technique and statistical/technical data analysis.
- Ensure data is reviewed and trends are investigated in a manner that ensures robust process quality.
- Provide guidance in structure of product development process documentation.
This position could be a great fit for you if you have a passion for quality, and the following:
- BS in Engineering or Life Sciences
- 5-8 years of quality assurance or quality engineering experience in the medical device or pharmaceutical industry
- Quality engineering support experience for process improvement or process development.
- Experience in process/equipment validation.
- Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients.
- In depth understanding of common process development and engineering development activities and proficient in experimental statistical and design of experiments.
- In depth understanding of design control and regulatory requirements for process design and transfer.
- In depth understanding of current good manufacturing practices (cGMP) and typical regulatory concerns affecting medical device and/or drug manufacturing.
Requirements
- BS in Engineering or Life Sciences
- 5-8 years of quality assurance or quality engineering experience in the medical device or pharmaceutical industry
- Quality engineering support experience for process improvement or process development
- Experience in process/equipment validation
- Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients
- In depth understanding of common process development and engineering development activities and proficient in experimental statistical and design of experiments
- In depth understanding of design control and regulatory requirements for process design and transfer
- In depth understanding of current good manufacturing practices (cGMP) and typical regulatory concerns affecting medical device and/or drug manufacturing
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
- 401k plan
- Company matching contribution
- 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.