Specialist, Facilities

Orca Bio•Sacramento, CA

8d•Hybrid

About The Position

The Specialist, Facilities is responsible for facilities, utilities and production and laboratory assets across multiple production sites producing clinical and commercial drug products. This role involves providing technical expertise for asset operation and troubleshooting, and utilization of a Computerized Maintenance Management System (CMMS) to manage asset data, asset labelling, asset status, and to coordinate and execute preventative and corrective maintenance, calibration and certification activities to ensure compliant and reliable operations to support production requirements to meet customer needs. They will also be responsible for managing and executing various projects in support of facility and utility system operations.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Facility Management or equivalent technical experience
4 years of experience in GMP manufacturing facility, including equipment operation and troubleshooting, and facilities and asset maintenance execution in a GMP manufacturing facility
Experience in analyzing, managing, and reporting reliability metrics, and managing assets and maintenance activities using a CMMS system
Experience coordinating onsite and offsite maintenance, calibration and certification activities completed by service providers
Experience in managing and executing facility and utility projects including repairs, improvements and new installations.
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Willing to support sites after-hours on an as needed or on-call basis
Strong interpersonal skills and ability to communicate effectively
Strong problem-solving and critical thinking skills to support making decisions in a timely manner, and desire to improve upon established processes
Ability to gown and work in clean room areas
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.
Ability to work for extended periods of time at a computer
Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking

Responsibilities

Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures
Track and report on equipment downtime, failure trends and develop corrective actions to prevent recurrence
Planning, scheduling and coordinating onsite and offsite preventative and corrective maintenance, calibration and certification activities to be completed by service providers
Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS
Ensure that facilities, utilities, production and laboratory assets are maintained, calibrated, and certified to applicable GMP standards
Collaboration with peers in the continuous improvement of equipment standards, practices, specifications, procedures, qualifications and business processes
Lead and/or participate in the identification and development of solutions to stabilize and optimize equipment systems
Execution of facility preventative and corrective maintenance tasks, small projects and continuous improvements
Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status, labelling, and assigning required maintenance, calibration and certification plans
Other duties as assigned