Technician, Lab Systems and Equipment

Orca Bio•Sacramento, CA

11d•Onsite

About The Position

The Lab Systems Equipment Technician, working within the Quality Control group, is responsible for supporting the operation, maintenance, calibration, and documentation of laboratory equipment used in GMP cell therapy manufacturing and testing. This role performs routine equipment-related activities, assists with troubleshooting, maintains equipment records, and helps ensure compliance with applicable procedures and regulatory requirements. The successful candidate is detail-oriented, organized, and capable of working in a regulated environment while supporting laboratory and manufacturing teams with equipment maintenance and operational readiness. The ideal candidate has an understanding of laboratory instrumentation, compliance standards (such as GMP and 21 CFR Part 11) to ensure QC and other cell therapy manufacturing equipment is qualified, maintained, and compliant with regulatory requirements.

Requirements

Associate degree in a scientific or technical discipline, or equivalent combination of education and relevant experience.
0 to 2 years of experience supporting laboratory equipment, instrumentation, maintenance, calibration, or related technical activities in a regulated environment.
Ability to wear cleanroom gowning and meet requirements of controlled and classified manufacturing spaces.
Basic understanding of laboratory instrumentation and equipment operation.
Ability to follow written procedures and accurately complete documentation.
Strong organizational skills and attention to detail.
Ability to identify equipment issues and communicate findings to appropriate personnel.

Nice To Haves

Bachelor's degree in biology, biochemistry, engineering, biotechnology, or related scientific discipline.
Experience in GMP, biotechnology, pharmaceutical, medical device, or cell therapy environments.
Experience supporting equipment calibration, maintenance, or qualification activities.
Familiarity with electronic systems, computerized equipment, and GMP documentation practices.
Strong communication and teamwork skills
Willingness to learn new equipment and technologies.

Responsibilities

Perform routine inspection, cleaning, calibration coordination, and maintenance activities for laboratory equipment.
Serve as a system administrator for benchtop instruments (e.g., balances, pH meters, spectrophotometers).
Manage user access, software updates, backup, and recovery processes in accordance with data integrity policies.
Perform audit trail reviews of equipment.
Execute preventative maintenance schedules and ensure equipment remains in qualified status.
Maintain equipment logbooks, maintenance records, and supporting documentation.
Assist with equipment setup, installation, relocation, and commissioning activities.
Support troubleshooting efforts by identifying basic equipment issues and escalating complex problems as appropriate.
Coordinate vendor service visits and ensure required documentation is completed and filed.
Support equipment inventory management and labeling activities.
Perform routine data backup activities following approved procedures.
Maintain equipment records and documentation in accordance with GMP and data integrity requirements.
Assist with audit trail review activities and documentation, as assigned.
Support investigations, deviations, CAPAs, and change controls related to laboratory equipment.
Follow procedures designed to ensure compliance with applicable regulatory requirements and ALCOA+ principles.
Support laboratory personnel with equipment operation and day-to-day equipment-related needs.
Assist with method transfers, equipment qualifications, and validation activities.
Collaborate with Quality Control, Manufacturing, Facilities, Validation, and IT personnel to ensure equipment readiness and compliance.
Participate in continuous improvement initiatives to improve equipment reliability and laboratory efficiency.
Complete equipment records, forms, and logs accurately and in a timely manner.
Assist in the preparation and revision of equipment-related SOPs, work instructions, and forms.
Support inspection readiness activities by maintaining organized and compliant records.