Design Quality Engineer

Apio, Inc.; Chaska (MN); On-site; USD 80,000 - 92,000; Full time

Benefits offered by this job

Medical plans + HSA

Dental & Vision

Disability insurance

Life insurance

PTO: 3 weeks

Company holidays

Tuition reimbursement

401k with match

Job summary

Lifecore Biomedical, LLC in Chaska, MN is seeking a Design Quality Engineer to apply Quality by Design and lead qualification activities across processes, equipment, and systems during new product development.

The role emphasizes risk management, validation strategies, and collaboration with cross-functional teams to ensure regulatory compliance and product quality.

Qualifications

• BS in Engineering or Life Sciences.
• 2-5 years of QA or QE experience in an FDA-regulated environment.
• Experience with process and equipment validation preferred.
• Biology/chemistry production background is a plus.

Responsibilities

• Lead quality system activities related to equipment, systems, and manufacturing processes, including validation, reports, investigations, and process trending.
• Provide QA support for new process development, technology transfer, and qualification projects.
• Develop validation strategies based on risk, understanding, and regulatory requirements.
• Review and approve validation protocols, reports, and production-related documents.
• Qualify new equipment, facility changes, utilities, and processes through IQ/OQ/PQ/PPQ.
• Monitor process trends and performance metrics; contribute to quality records and deviations.
• Facilitate risk assessments related to quality systems and product changes.
• Review Change Orders to assess quality and regulatory impact.
• Collaborate with cross-functional teams and customers for product development and improvement.

Skills

Quality Assurance

Quality Engineering

FDA compliance

Process Validation

Equipment Validation

Biology background

Education

BS in Engineering

Life Sciences degree

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Design Quality Engineer

Regular Full-Time Professionals Chaska, MN, US

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, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.

We are seeking a Design Quality Engineer to join our MS&T team. In this role, you will provide quality engineering expertise in support of process and equipment validation, new business development, and customer interactions during new product development activities. This role applies Quality by Design (QbD) principles and effective risk management practices to ensure products, processes, equipment, and systems meet quality and regulatory requirements.

In this critical engineering role, you will:

• Lead quality system activities related to equipment, systems, and manufacturing processes, including validation, report generation, investigations, and process trending.
• Provide quality engineering support for new process development, technology transfer activities, and equipment or facility qualification projects.
• Develop validation strategies based on product risk, process understanding, and applicable regulatory requirements.
• Review and approve controlled documentation, including validation protocols and reports, production-related documents, nonconformities, validation deviations, and other quality records.
• Qualify new equipment, facility changes, utilities, and manufacturing processes through IQ/OQ/PQ/PPQ activities.
• Establish, analyze, and monitor process trends, performance metrics, and process capability data for systems, processes, and products.
• Facilitate and document risk assessments related to quality systems, new process development, process improvements, and product changes.
• Review and approve Change Orders to ensure appropriate assessment of quality and regulatory impact.
• Partner with cross-functional teams and customers to support successful product development, commercialization, and continuous improvement initiatives.

This position could be a great fit for you if you have a passion for problem solving, and the following:

• BS in Engineering or Life Sciences
• 2-5 years’ experience in Quality Assurance or Quality Engineering in an FDA regulated industry
• Experience in process/equipment validation (Preferred)
• Background in biology and/or chemistry production processes a strong plus!

Starting Salary: $80,000 - $92,000 annually with consideration for relevant skills and 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 company contributions.
  • Low cost dental and vision insurance
  • Short term disability, long term disability and life insurance all 100% company paid
  • 3 weeks PTO in the first year (increases to 4 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.