We're looking for a highly motivated Senior Engineer to join our dynamic Technical Operations team in Fremont, California. Reporting to the Chief Technical Officer, you will be instrumental in evolving our GMP processes and instrumentation for clinical manufacturing. You'll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases.
Responsibilities
- Owning the site-wide metrology program, ensuring all instrumentation is calibrated, maintained, and performing within established tolerances to support a validated state of operation.
- Leading the commissioning and qualification (C&Q) of systems for pre-clinical and clinical cell therapy manufacturing, applying risk-based strategies. Ensure all systems meet GAMP5 and Data Integrity standards.
- Generating and defending lifecycle documentation, including System Impact Assessments, URS, FMEAs, and IQ/OQ/PQ protocols. Standardize and improve business processes for equipment intake, periodic reviews, and change control to increase site efficiency and compliance.
- Serving as the primary engineering partner for R&D and Manufacturing during the design and modification of new systems, participating in design reviews and technology transfers.
- Successfully defend engineering and validation packages during internal and regulatory inspections (FDA, EMA, Health Canada), serving as the Subject Matter Expert (SME) for equipment reliability and data integrity.
- Directing resource allocation and test scheduling for complex engineering projects, ensuring timelines are met without compromising quality or safety.
- Implementing an effective Maintenance Management System including asset registry, PM schedule, work order tracking, replacement parts inventory and tracking, and metrology and calibration tracking. Lead root-cause investigations into equipment failures.
Qualifications
The hiring range for this role is $128,452 - $136,000, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.
Who We Are
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!
Curious about our current perks and benefits? Learn more here.
At Aspect Biosystems, our strength has always been in our diversity. Different people, thinking differently, unified in creating a world that is better for us all. We are committed to creating an inclusive environment for everyone on our team. All aspects of employment — including the decision to hire, promote, discipline, or terminate — are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, colour, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, provincial, or local law.
If you're interested in joining our team but don't see a job posting that matches your experience or background, we encourage you to submit a general application to be considered for future opportunities!
