Calibration Technician

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.
Summary of Position: The Calibration Technician is responsible for inspecting, testing, calibrating, and maintaining measurement and test equipment to ensure accuracy and compliance with industry standards and company quality requirements. The Calibration Technician works closely with other departments to support the overall goals of the organization.

Physical Demands & Work Conditions

• Production Associates: 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.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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.
• Must be comfortable regularly participating in video-based meetings.

Key Responsibilities:

• Perform calibration, adjustment, and repair of equipment used in GMP Production and Quality Control Lab testing (mechanical, electrical, electronic, and dimensional).
• Maintain calibration records in accordance with quality standards (ISO, ANSI, NIST, etc.).
• Utilize and maintain a Computerized Maintenance Management System (CMMS) to accurately track, plan, and document asset calibration, repairs, and inventory, ensuring data integrity for regulatory compliance.
• Troubleshoot equipment performance issues and recommend corrective actions.
• Ensure all Calibration Standards meet required tolerances and specifications.
• Author and update calibration procedures.
• Assist with internal and external audits.
• Maintain a clean and organized calibration lab.
• Coordinate with production and engineering teams to minimize downtime.

Qualifications:

• Associate degree or technical certification in Electronics, Engineering Technology, or related field (or equivalent experience).
• 4 years of calibration experience in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility.
• Strong knowledge of measurement principles and standards (ISO 9001, ISO/IEC 17025 preferred).
• Experience with Calibration Standards such as multimeters, temperature sensors pressure gauges, torque tools, tachometers, calipers, and other precision instruments.
• Experience with GMP regulatory standards, and documenting work per GDP requirements.
• Ability to read technical drawings and schematics.
• Strong attention to detail, documentation, communication, and interpersonal skills.
• Proficiency in Microsoft Office, maintenance management, and calibration management software.
• Familiarity with NIST traceability requirements.
• Strong problem-solving and analytical skills.
• Ability to work independently and as part of a team.
• The position requires on-site presence and typically involves regular hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response.
• Gowning for cleanroom access.
• Ability to lift up to 40 lbs.
• Manual dexterity for handling small components.

The anticipated annual salary range (listed above) 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. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized 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.