Calibration & Facilities Engineer

Aspect Biosystems•Fremont, CA

1d•Onsite

About The Position

We are looking for an enthusiastic, experienced Engineer to join our team in Fremont. Reporting to the Senior Engineer, you will provide essential technical support for the Fremont site’s metrology program and facility operations. This role is a mix of hands-on technical execution and project coordination, ensuring that manufacturing equipment and site utilities (HVAC, electrical, and mechanical) are calibrated, maintained, and compliant with site standards. You will be directly contributing to our groundbreaking programs and our mission to develop bioprinted tissue therapeutics to transform the lives of people with serious diseases. Aspect Biosystems is a Canadian biotechnology company creating bioprinted tissue therapeutics to transform how we treat disease. Our bold team of innovators and entrepreneurs have joined us from all over the globe to create a new class of regenerative medicine and work towards a future where our bioprinted tissues are used to save lives and make people healthier. We are endlessly curious and wildly passionate about what we do. Every person on our team is a key contributor to our success and is eager to roll up their sleeves to make a difference in the ever-changing world of biotech. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!

Requirements

A bachelors or masters in engineer.
3–5 years of experience in a regulated industry (Biotech, Pharma, or Med Device), with a strong preference for experience in metrology or facility engineering.
Knowledge of NIST standards, HVAC, Utility Systems (including WFI, gases).
Ability to coordinate multiple vendor schedules simultaneously.
Familiarity with reading and interpreting P&IDs, drawings, specifications.
Reviewing turnover packages, vendor documentation.
Familiarity with conducting or coordinating FAT and SAT testing.
Love immersing yourself in difficult technical problems and coming up with solutions that work.
Think outside the box and use your experience and intuition to identify when such solutions are realistic.
Outstanding attention to detail as well as experimental and process rigour.
Take pride in your work and strive for excellence.

Responsibilities

Executing the site-wide metrology program, coordinating the calibration and maintenance of all instrumentation to ensure systems remain within established tolerances and support a validated state of operation.
Supporting the Commissioning, Qualification, and Validation (CQV) of manufacturing equipment and facility utilities (HVAC, water, and gas systems) under the guidance of the Senior Engineer, applying risk-based strategies and GAMP5 standards.
Drafting and maintaining lifecycle documentation, including URS, FMEAs, and IQ/OQ/PQ protocols.
Assisting in the standardization of equipment intake processes and periodic reviews to increase site efficiency.
Coordinating with the Manufacturing team during the installation and modification of new systems, acting as a technical resource for equipment design reviews and technology transfers.
Monitoring facility operations and utilities as well as supporting the maintenance of HVAC and mechanical systems to ensure cleanroom environments and production areas meet performance specifications.
Managing and handling facility gas systems, including under GMP requirements (daily checks, inventory control of gas cylinders/spares, physically changing/replacing cylinders, etc).
Assisting in regulatory inspection readiness by organizing engineering and validation packages (FDA, EMA, etc.) and acting as a secondary Subject Matter Expert (SME).
Administering the Maintenance Management System (CMMS), BMS, FMS, performing data entry and tracking for the asset registry, PM schedules, and replacement parts inventory.
Assisting in root-cause investigations for equipment failures or out-of-tolerance events will be among your duties.
Facilitating vendor management and test scheduling, ensuring third-party contractors complete calibrations, repairs, preventive maintenance, equipment install, and external IQ/OQ testing on time and in compliance with site safety, quality, and Good Documentation Practice (GDP) standards.
Overseeing the security of site, facility maintenance and cleaning of controlled and non-controlled areas.
Creating and maintaining accurate documentation, SOPs, and records for calibrations, maintenance, facility, and utilities.
Other duties as required.