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. To support all phases of the equipment lifecycle including requirements, design, optimization, qualification and maintenance.
Personal and Technical Skills
- “Hands On” mechanical aptitude and Engineering
- In depth understanding of documents, SOP’s, and technical drawings.
- Proficient in Microsoft Word, Excel, and Project. CAD Experience desirable.
- In depth understanding of materials of construction, piping, pumps, valves, filters, mixers, tanks, controllers, skid mounted processing units, and their integration into all company manufacturing processes and systems.
- Understanding of packaging materials and equipment including filling, closing, secondary and final packaging.
- In depth understanding of design control and regulatory requirements for process design and transfer.
- Planning and prioritizing skills related to long and short range goals.
- Ability to work proactively with department supervisors to create a more robust manufacturing operation.
- Ability to research, recommend, and specify new equipment.
- Understanding of GMP's and basic regulatory issues affecting medical device or drug manufacturing.
- BS in Engineering or Science (Mechanical or Chemical preferred).
- 2– 5 years experience in the medical device or biopharmaceutical industry.
- Experience with clean room systems.
Job Type: Full-time
Salary: $80,000.00 to $90,000.00 /year
- Manufacturing Engineering: 2 years
- medical device: 1 year
- Minneapolis-Saint Paul, MN