Process Engineer

Process Engineer

In this role, you will support the day-to‑day operation, maintenance, troubleshooting, and repair of PAT instruments used in GMP manufacturing. You will collaborate closely with the Frontline Upstream System Owner, Manufacturing, and Instrumentation staff to assess system issues, perform equipment health checks, execute planned improvements, and assist with investigations into unplanned events. This position supports the deployment of several new PAT systems alongside existing instruments, providing an opportunity to gain hands‑on experience with advanced PAT used in mammalian cell culture and purification operations.

• Perform routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers.
• Support manufacturing operations by responding to system‑related issues, troubleshooting instrument performance, and documenting observed problems.
• Assist in the investigation of unplanned equipment events using structured problem‑solving tools and contribute to root cause assessments.
• Conduct equipment health monitoring and contribute to reliability improvement activities to increase system uptime.
• Execute planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.
• Review and interpret instrument data to identify basic trends or abnormalities.
• Support adherence to data integrity principles and help maintain data consistency within systems such as Smartline Data Cockpit.
• Collaborate with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.
• Assist with documentation updates, track work activities, and prepare technical summaries as needed.
• Work independently to accomplish assigned tasks while keeping stakeholders informed of progress.

• Bachelor's in an engineering or analytical/scientific discipline.
• Prior hands‑on experience with analytical systems is required.
• Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.
• Experience using cell counters and metabolite analyzers in GMP Manufacturing or QC Labs preferred.
• Experience troubleshooting analytical instruments and interpreting equipment performance data.
• Strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.
• Ability to work independently and manage assigned tasks with limited supervision.
• Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.
• Strong verbal and written communication skills, including documentation, reporting, and stakeholder updates.
• Ability to build productive working relationships with end users and equipment vendors.

• Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.
• Flexibility in problem solving and work hours to meet business objectives.
• General understanding of biotech analytical methods and laboratory practices.
• Strategic thinking mindset with the ability to convert system needs into actionable activities.
• Process improvement, Lean manufacturing, instrumentation, GMP, troubleshooting, Six Sigma, manufacturing process, data integrity.

This is a Contract position based out of Vacaville, CA. This is a fully onsite position in Vacaville, CA.

The pay range for this position is $22.00 – $36.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance…