Facilities Operations Manager

6 days ago


Sacramento, California, United States Orca Bio Full time
Job Summary

Orca Bio is seeking a highly skilled Facilities Operations Manager/Asset Management Specialist to join our team. This role is responsible for managing asset data, labelling, and maintenance across multiple production sites producing clinical and commercial drug products.

Key Responsibilities
  • Develop, implement, and revise Standard Operating Procedures (SOPs) and Work Instructions (WIs) for GMP Facility and asset management programs.
  • Onboard new assets and maintain current assets in the Computerized Maintenance Management System (CMMS), including asset identification and status, labelling, and assigning required maintenance, calibration, and certification plans.
  • Plan, schedule, and coordinate onsite and offsite maintenance and calibration activities to be completed by service providers or company personnel.
  • Review, approve, and retain service provider documentation.
  • Ensure that the facility and assets are maintained, calibrated, and certified to applicable GMP standards.
  • Execute facility preventative and corrective maintenance tasks, and small projects and continuous improvements.
  • Manage spare parts program to ensure strategies are developed and required inventory is in place.
  • Tracks and reports metrics on asset maintenance and identifies risk, needs, and opportunities.
Requirements
  • Experience using a GMP CMMS for asset management.
  • Experience implementing a CMMS, preferably in a GMP environment.
  • Demonstrated knowledge of facility and asset maintenance and calibration programs.
  • Experience in planning, scheduling, and coordinating GMP facility and asset maintenance and calibration activities.
  • Effective communication and coordination skills to consult with internal teams and external service providers.
  • Proactive approach to identifying and implementing improvements in asset management systems and work processes.
  • Familiarity with industry best practices and a commitment to staying updated on emerging trends in facilities and asset management.
Preferred Attributes
  • Ability to multitask and handle multiple responsibilities simultaneously.
  • Strong work ethic, curiosity to learn, and contribute in a fast-paced collaborative environment.
  • Strong interpersonal skills and ability to communicate effectively.
  • Strong problem-solving and critical thinking skills to support making decisions in a timely manner.
  • Ability to gown and work in clean room areas from time to time.
  • Ability to work in a collaborative manner, independently, and as part of a team.
  • Ability to work in a fast-paced start-up environment while following documented procedures and instructions.


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