Specialist, Laboratory Systems and Equipment

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 late-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 investigational 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 Specialist, Laboratory Systems and Equipment position, working in the Quality Control group, is detail-oriented and technically skilled. The successful candidate will be responsible for the system administration of benchtop laboratory equipment and the management and assurance of data integrity to meet regulatory requirements. This role requires a strong understanding of laboratory instrumentation, compliance standards (such as GMP and 21 CFR Part 11), and project management principles to ensure QC and other cell therapy manufacturing equipment is qualified, maintained, and compliant with regulatory requirements.

• Benchtop Equipment System Administration:
• Serve as the primary system administrator for benchtop instruments (e.g., balances, pH meters, spectrophotometers).
• Oversee equipment qualification (IQ/OQ/PQ), calibration, maintenance scheduling, and documentation.
• Manage user access, software updates, backup, and recovery processes in accordance with data integrity policies.
• Partner with IT and instrument vendors to ensure systems are secure, validated, and audit- ready.

• Data Integrity and Compliance:
• Lead gap assessments for benchtop equipment to identify and remediate data integrity vulnerabilities.
• Implement corrective and preventive actions (CAPAs) related to data handling, user access, and audit trails.
• Ensure systems meet applicable regulatory standards, including ALCOA+ principles.

• Project Management:
• Develop and manage project plans for equipment upgrades, data integrity remediation, and system implementations.
• Coordinate cross-functional teams, manage timelines, track milestones, and report progress to stakeholders.
• Prepare and maintain documentation to support project execution and regulatory inspections.

• Collaboration and Support:
• Support method transfers, instrument troubleshooting, and change control processes.
• Train QC analysts, Manufacturing, and other users on equipment operation and compliance practices.
• Contribute to continuous improvement initiatives to enhance equipment performance and data quality.

• 2+ years of experience working with benchtop analytical equipment, acting as a system owner, system administrator, or performing troubleshooting / maintenance on the system
• Ability to wear cleanroom gowning and meet the requirements of the controlled, classified spaces
• Hands-on experience with benchtop instrumentation and laboratory information systems
• Experience identifying and supporting resolution of technical problems
• Has actively participated in group and project teamwork; project and process improvements

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.)
• Knowledge of data integrity standards and system validation (CSV)
• Excellent organizational, communication, and problem-solving skills
• Detail-oriented with a strong commitment to data integrity and accuracy
• Ability to work independently and as part of a team in a fast-paced and regulated environment
• Adaptable and responsive to changing priorities and challenges

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.