Sterile Manufacturing Engineer – Process & Equipment

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

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.