Design Quality Engineer — Growth, Validation, Impact

Apio, Inc.; Chaska (MN); In loco; USD 80.000 - 92.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical plans + HSA

Dental & Vision

Disability insurance

Life insurance

PTO: 3 weeks

Company holidays

Tuition reimbursement

401k with match

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality Assurance

Quality Engineering

FDA compliance

Process Validation

Equipment Validation

Biology background

Formazione

BS in Engineering

Life Sciences degree

Descrizione del lavoro

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.

Senior Design Quality Engineer

C00700 - MS&T Regular Full-Time Chaska, MN, US

30+ days ago Requisition ID: 1549

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 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.

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.

Starting Salary: $95,000 - $115,00 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.