Specialist, Facilities in Sacramento, California at Orca Bio
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Job Description
- Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
- Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
- Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
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
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
$70,000 - $90,000 a year