Manager, Operations Maintenance

JOB TITLE: Manager, Operations Maintenance
LOCATION: Cypress, CA
DURATION: TBD
PAY RANGE: $62 - $63/hr.

• 5+ years manufacturing/operations experience with 2+ years in facilities or maintenance management within Medical Device, Pharma, or Biotech environments; strong knowledge of cGMP, ISO 13485, and FDA regulations.
• Proven leader of technical/facilities teams overseeing critical equipment, PM programs, and compliance in high-reliability environments (HVAC, electrical, production equipment, Client/EMS).
• Strong project management and continuous improvement skills, including SOP development, audit support, data-driven decision making, and lean manufacturing principles.

Manages the design, planning, construction, and maintenance of equipment, machinery, buildings, and other facilities. Plans, budgets, and schedules facility modifications, including estimates on equipment, labor, materials, and other related costs. Designs and develops organizational policies relevant to the facilities department. Oversees the coordination of building space allocation and layout, communication services, and facilities expansion. May have responsibility for establishing and overseeing health and safety standards.

Selects, develops, and evaluates personnel to ensure the efficient operation of the function. Facilities Management overseeing the operation of mechanical, electrical, and plumbing systems in a high-risk or high-reliability environment, dependent on mission-critical equipment and sensitive operating conditions, should be matched to Critical Facilities.

• Manage technical resources, including equipment and tools.
• Provide technical expertise and guidance to production teams and other departments.
• Keep all critical equipment in compliance with regulatory standards and in good working order.
• Maintain Manufacturing/Lab equipment maintenance, including but not limited to, production equipment, HVAC, humidifier system, and electrical equipment via a Client/EMS control system.
• Perform cGMP facility inspections and report on conditions affecting operations;
  Apply knowledge of cGMPs daily.
• Develop and revise Standard Operating Procedures and manage or support key audit and compliance activities.
• Locate and diagnose failures, replace defective components, and troubleshoot technical issues.
• Identifying and implementing strategies to reduce equipment PM costs and increase productivity.
• Ensure all PM’s functions are performed safely and in accordance with applicable laws and regulations, as well as company policies, procedures, and controls.
• Work closely with engineering, quality, and other departments to ensure compliance with equipment maintenance requirements.
• Write and review SOPs as directed by QA/OPS/EHS.
• Analyze production/facility equipment data to identify trends and areas for improvement.
• Communicate the status of KPI’s and/or work assignments to internal Operations/Quality stakeholders.
• On call for critical equipment and system failures.
• Additional responsibilities as assigned by leadership.

• Bachelor’s degree in industrial/manufacturing engineering or an alternate technical discipline, preferred.
• Minimum 5+ years’ progressive operations/manufacturing experience with at least 2 years of that in management within a manufacturing environment preferred.
• Medical Device, Pharma, or Biotech experience; thorough understanding of ISO 13485 and FDA regulations.
• Proven track record of leading a team to consistently deliver high-quality products/services.
• Demonstrated leadership skills; clear examples of motivating, influencing, and developing team members at all levels.
• Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
• Strong communication and interpersonal skills; ability to effectively communicate complex information to all employee levels, and to set clear expectations.
• Experience with lean manufacturing (or similar) principles.
• Proficient in Microsoft Office:
  Excel, PowerPoint, and Word

Benefits summary:
Individual compensation is determined by skills, qualifications, experience, and location. Compensation details listed in this posting reflect the base hourly rate or annual salary only, unless otherwise stated. In addition to base compensation, full-time roles are eligible for Medical, Dental, Vision, Commuter and 401K benefits with company matching.