Job Title: Facilities Engineer Duration: 12+ Months (Possible extension) Location: Maple Grove, MN 55311 Onsite Role Responsibilities:- Past experience in designing, building an Aseptic manufacturing facility.
- Experience in validation of CAPA , ISO 13408/14644 experience, leading Audit experience
- Project cost management , contract negotiations and working with cross functional teams
- Ensure smooth operation of facilities and building systems in Maple Grove manufacturing plant to include leading design, contract, and build out of future spaces.
- Maintains one or more of the following facility systems as assigned by supervisor:
- Process water system
- Clean room system
- Incoming power and gas
- Compressed air system
- Boiler system
- Building maintenance
- Fire protection system
- Building management and control system
- Lead in system upgrading and/or improvement projects including validation requirement
- Lead improve all facilities and building systems reliability
- Continual review of facilities and building systems for equipment capacity, reliability, energy efficiency and recommend improvement or upgrading
- Lead cross functional operation and quality team to resolve facilities system or quality related issues
- Monitor and maintain facilities systems and procedures to comply to cGMP systems, regulatory, quality
- Prepare and participate in Quality audits
- Participate in annual budgeting process and ensure spending meets objectives
Education/Experience:- 5 - 8 Years with bachelor's degree in engineering or related field
- Experience working in a medical device manufacturing environment with a preference for aseptic processing facilities (food, pharma, med device, data centers).
- Proven expertise in usage of MS Office Suite
- Excellent written and verbal communication skills and interpersonal skills including consultative and relationship management skills with ability to drive achievement of objectives
- Demonstrated conflict resolution skills
- Strong leadership skills with demonstrated ability to influence change
- Proven success adhering to and leading project schedules and managing projects
- Substantial understanding and knowledge of facilities systems and preventive maintenance programs
- Substantial knowledge of facilities related government regulations, GMP, and EHS