Sr. Facilities Engineer

Responsible for ensuring smooth operation of facility systems in a medical device manufacturing plant, including managing the design, build, qualification, and validation of aseptic manufacturing spaces.

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Job Requirements:

• Bachelor’s degree in Engineering or related field.
• 5-8 years of experience in facilities management within a medical device, pharmaceutical, or aseptic manufacturing environment.
• Experience designing and building aseptic manufacturing facilities.
• Knowledge of ISO 13408/14644 standards and cGMP regulations.
• Expertise in qualification, validation, and audit processes.
• Proven experience in project cost management, contract negotiations, and working with cross-functional teams.
• Proficiency with MS Office Suite.
• Strong knowledge of facilities systems and preventive maintenance programs.
• Familiarity with regulatory, GMP, and EHS compliance requirements.

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Preferred Skills:

• Experience in aseptic processing facilities, such as food, pharma, or data centers.
• Strong leadership and project management skills with a proven track record of adhering to project schedules.
• Knowledge of building management systems and energy efficiency improvements.
• Familiarity with preparing for and leading quality audits.

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Job Responsibilities:

• Ensure smooth operation of facilities and building systems in the Maple Grove manufacturing plant, including process water, clean room, HVAC, compressed air, boiler, fire protection, and building management systems.
• Lead the design, contract negotiations, and buildout of future aseptic manufacturing spaces.
• Oversee system upgrades and improvements, including validation requirements.
• Drive continuous improvements in facility system reliability, capacity, and energy efficiency.
• Lead cross-functional teams to resolve facility system or quality-related issues.
• Monitor and maintain facilities systems to ensure compliance with cGMP, regulatory, and quality standards.
• Prepare for and participate in quality audits.
• Manage project costs and participate in the annual budgeting process to ensure spending aligns with operational objectives.
• Maintain compliance with all safety and environmental regulations, taking preventive measures to ensure the safety of personnel and protection of the environment.

Pay Details: $47.00 to $53.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance