Sr. Manufacturing Engineer
Our client is a growing biotechnology/life sciences company located in southern Minnesota has an opportunity for a scientist who has experience with molecular cloning. Our client is a leading provider of products and services to accelerate development of viro-immuno-oncology drugs.
Our Client is looking for Sr. Manufacturing Engineer – Aseptic who will Lead and supervise the aseptic engineering activities ensuring timely and effective development, validation, and robust operation of equipment and processes while complying with quality and regulatory requirements.
The activities include but not limited to capital equipment purchase, implementation and validation, new product development testing and validation, as well as continuous improvement and troubleshooting on existing manufacturing processes. Assist with supervising 2 areas of work: Project Engineering and Steady State Engineering
- Paid Holidays and PTO
- Employer paid Short/Long Term Disability/ Life Insurance, AD&D and Dental
- Simple Retirement Plan with an employer match
- Client has adjusted salaries to accommodate the employee in purchasing Medical insurance thru an outside vendor.
- BS in Engineering or Science (Mechanical – Preferred!)
- Min 5 yrs of experience in engineering in the medical device/biopharmaceutical or other highly regulated industry
- Previous Experience writing engineering specs
- Project Management experience
- Previous experience in process/equipment validation
- "Hands On" mechanical aptitude and Engineering skill
- Understanding of documents, SOP's, preventative maintenance procedures, and technical drawings
- Microsoft Word, Excel, and Project - Proficient
- CAD Experience – A Plus!
- Understanding of materials of construction, piping, pumps, valves, filters, mixers, tanks, controllers, skid mounted processing units, and their integration into all manufacturing processes and systems
- Understanding of design control and regulatory requirements for process design and transfer
- Planning and prioritizing skills related to short- and long-range goals
- Collaborative Team Player
- Previous experience mentoring others
- Ability to research, recommend, and specify new equipment
- Ability to lead a team through the equipment implementation process
- Understanding of GMP's and basic regulatory issues affecting medical device / drug manufacturing
- Ability to identify manufacturing setback and correct them
- Ability to qualify to ISO 5/6 gowning standards
- Previous Experience in aseptic processing – syringe filling, aseptic technique, and understanding of aseptic syringe and vial filling
- Must have completed smoke studies and worked with isolators
- Assist with regulatory requirements and clean room requirements