Sr. Calibration Specialist
Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches.
Sutro Biopharma, Inc. is looking for a Sr. Calibration Specialist experienced in calibration services to support Sutro’s cGMP facilities in San Carlos. This individual will report to the Associate Director, Plant Operations. You will be working in the Facilities and Engineering Department which supports manufacturing and quality control groups.
The Sr. Calibration Specialist is a forward facing, customer focused role and will be responsible for supporting operations in Sutro Biopharma’s cGMP Manufacturing Facility which will include:
- Oversee the successful management of the site calibration schedule
- Point of contact and SME for the calibration program, representing the department for internal, business partner and agency inspections or audits.
- Schedule calibrations with internal customers to minimize impact to production and testing schedule
- Schedule, supervise and review calibrations from outside service providers
- Track the progress of the assets within the calibration program and update the Facilities metrics workbook
- Proficiency in all related Quality Documents such as Deviation, CAPA management, Change Control Requests
- Ability to work in a classified clean suite performing installation, repair, start up, troubleshooting, and calibration of instrumentation and machines.
- Support the manufacturing site to install, troubleshoot, test and repair control systems and processing equipment.
- Perform the onboarding and offboarding documentation requirements for assets at the manufacturing site
- Access the work request system and generate work orders, implement solutions for requesters and close out work orders upon completion.
- On-call for after-hours building and system alarm response.
- Ability to author, edit and follow standard operating procedures.
- Monitor and respond to building and systems monitoring alarms. Notify the appropriate personnel and possibly correct the discrepancy as needed.
Additional responsibilities may include:
- This individual will share responsibility with the entire Facilities Team to support the building infrastructure and utilities.
- Maintain spare parts inventory stock for critical instruments
- Physical requirements include ability to lift 50 lbs., frequent standing, walking, sitting and reaching with arms and hands.
- Reliable, organized, excellent attention to details with demonstrated ability to manage multiple tasks
- Excellent communication skills and team player.
- Possession of a reliable vehicle, liability insurance coverage and a California driver’s license.
- Ability to respond to after-hours emergency calls within 45 minutes.
- Associates degree with 5+ years of experience or bachelor’s with 3 years of experience in a maintenance, instrumentation or facilities department.
- Experience in calibration and metrology departments, preferably GMP or ISO environment.
- Proficient in computer skills using a variety of standard and custom desktop or web-based software.
- Preferred training:
- Lockout / Tag out, Control of Hazardous Energies
- Chemical Safety/Hazardous Material Handling
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.