Sr. Facility Manufacturing Engineer

Job Title: Sr. Facility Manufacturing Engineer
Location: Maple Grove, MN
Duration: 12 Months on W2 – Hybrid
 
Pay Range: $50 - $56/hr. on w2

Job Purpose:
Job description:
Ensure smooth operation of facilities and building systems in Maple Grove manufacturing plant to include leading design, contract, and build out of future spaces.

Top 3 Skills:

1. Past experience in designing, building an Aseptic manufacturing facility.
2. Qualification , validation of APA , ISO 13408/14644 experience, leading Audit experience
3. Project cost management , contract negotiations, working cross functional teams ,

Responsibilities:

• Ensure smooth operation of facilities and building systems in Maple Grove manufacturing plant
• Process water system
• Clean room system
• Incoming power and gas
• Compressed air 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 audit
• Participate in annual budgeting process and ensure spending meets objectives

Job description:
Ensure smooth operation of facilities and building systems in Maple Grove manufacturing plant to include leading design, contract, and build out of future spaces.
This position maintains one or more of the following facility systems as assigned by supervisor:

• Process water system
• HVAC system
• Clean room system
• Boiler system
• Incoming power and gas
• Water supply
• Compressed air system
• Building maintenance
• Fire protection system
• Building management and control system

Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Experience in Aseptic Manufacturing Process is a plus.

Qualifications:

• 5 - 8 Years with BS,
• 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 to government regulations, GMP, and EHS
• Strong problem-solving, organizational, analytical and critical thinking skills
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others, as well as to the protection of environment and prevention of pollution under their span of influence/control