Technician, Lab Systems and Equipment

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. 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. ### Physical Demands & Work Conditions - *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. ### Key Responsibilities **Equipment Maintenance and Support** - 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. **Data Management and Compliance Support** - 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. **Operational Support** - 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. **Documentation** - 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. ### Minimum Qualifications - 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. ### Preferred Qualifications - 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. ### Physical Demands - Must be able to remain in a stationary position while reviewing records or working in a cleanroom environment - Must comply with gowning requirements (no cosmetics, jewelry, etc.) and disclose any shedding skin conditions - May need to ascend/descend stairs and walk through classified spaces during routine walkthroughs ### Personal Qualities - Highly detail-oriented with strong commitment to data integrity and documentation accuracy - Collaborative mindset with strong interpersonal and communication skills - Willingness to take initiative and provide support beyond defined responsibilities - Adaptable, dependable, and motivated by Orca Bio’s mission to serve patients