Manufacturing Engineer

Lifecore Biomedical Inc; Chaska (MN); On-site; USD 85,000 - 98,000; Full time

Benefits offered by this job

Medical plans (HSA)

Dental & vision

Disability & life insurance

PTO 3 weeks

Holidays & personal days

Paid family leave

Tuition reimbursement

401k with match

Job summary

Lifecore Biomedical, Inc. is seeking a Manufacturing Engineer in Chaska, MN to support equipment and process projects on our MS&T team.

The role focuses on ensuring equipment and processes meet client and regulatory requirements while maintaining the Quality System. You will design, transfer, and scale-up manufacturing processes for sterile products, lead equipment selection and installation, and drive process improvements with cross-functional teams.

Qualifications

• BS in Engineering (Mechanical or Chemical preferred)
• 2-5 years’ experience in the medical device or biopharmaceutical industry
• Experience with cleanroom systems
• Understanding of packaging materials and equipment including filling, closing, secondary and final packaging
• Comprehensive knowledge of document management, SOPs, technical drawings, design controls, and applicable quality system and regulatory requirements

Responsibilities

• Work closely with clients to design, transfer and scale-up manufacturing processes.
• Develop and implement innovative manufacturing solutions for complex sterile injectable products.
• Interact cross-functionally to facilitate the introduction of new manufacturing processes or changes to existing manufacturing processes.
• Lead the design, selection, and installation of new manufacturing equipment and systems.
• Investigate and resolve manufacturing process and equipment issues that adversely impact product quality and process performance.
• Seek and implement improvements in the process, related equipment, or facility.
• Collect and analyze relevant process data to aid in process improvements.
• Ensure compliance with the Quality System and Design Control requirements.
• Assist maintenance in diagnosing equipment failures.

Skills

Mechanical aptitude

Engineering skills

Education

BS in Engineering (Mechanical or Chemical preferred)

Tools

Cleanroom systems

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.

Manufacturing Engineer

Regular Full-Time Professionals Chaska, MN, US

3 days ago Requisition ID: 1554

It's not what we make. It's what we make possibleand the possibilities at Lifecore are endless!

Lifecore has an opening for a Manufacturing Engineer supporting equipment and process projects on our MS&T team. The primary responsibility of this position is to ensure equipment and processes are engineered to meet all client and regulatory requirements while maintaining an effective quality management system. Processes include cleaning, sterilizing, formulation, filtration, filling and packaging. They will support all phases of the equipment lifecycle including requirements, design, optimization, qualification and maintenance.

In this critical engineering role you’ll have the opportunity to:

• Work closely with clients to design, transfer and scale-up manufacturing processes.
• Develop and implement innovative manufacturing solutions for complex sterile injectable products.
• Interact cross-functionally to facilitate the introduction of new manufacturing processes or changes to existing manufacturing processes.
• Lead the design, selection, and installation of new manufacturing equipment and systems.
• Investigate and resolve manufacturing process and equipment issues that adversely impact product quality and process performance.
• Seek and implement improvements in the process, related equipment, or facility.
• Collect and analyze relevant process data to aid in process improvements.
• Ensure compliance with the Quality System and Design Control requirements.
• Assist maintenance in diagnosing equipment failures.

This position could be a great fit for you if you have strong mechanical aptitude and engineering skills, along with the following:

• BS in Engineering (Mechanical or Chemical preferred)
• 2-5 years’ experience in the medical device or biopharmaceutical industry
• Experience with cleanroom systems
• Understanding of packaging materials and equipment including filling, closing, secondary and final packaging
• Comprehensive knowledge of document management, SOPs, technical drawings, design controls, and applicable quality system and regulatory requirements

Starting Salary: $85,000 - $98,000 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 a generous company contribution.
  • 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.

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