Manufacturing Engineer
About the role
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.
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.
- Aid maintenance in diagnosing equipment failures.
Requirements
- BS in Engineering (Mechanical or Chemical preferred)
- 2-5 years’ experience in the medical device or biopharmaceutical industry
- Experience with cleanroom systems
- Comprehensive knowledge of document management, SOPs, technical drawings, design controls, and applicable quality system and regulatory requirements
Qualifications
- Strong mechanical aptitude and engineering skills
Skills
- Knowledge of cleanroom systems
- Document management and SOPs
- Technical drawings and design controls
- Quality system and regulatory requirements
Pay
Starting Salary: $85,000 - $98,000 annually with consideration for relevant skills and experience
Schedule
N/A
Benefits
- 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
Benefits
- Medical insurance plans
- Dental and vision insurance
- Short term disability, long term disability and life insurance
- Paid family leave
- Tuition reimbursement
- 401k plan with company matching contribution
Company Information
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.