Process Engineer
Listed on 2026-03-05
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Manufacturing / Production
Manufacturing Engineer, Quality Engineering
This position's starting pay is: $30.00/hourly.
Position Summary:
This position is located at our organization’s production facility in Vacaville, California. The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques.
This temporary contract position provides hands‑on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility. PAT systems play a critical role in monitoring mammalian cell culture processes by measuring key parameters such as cell density, viability, and metabolite concentrations. Maintaining these systems in a reliable, ready‑to‑use state is essential for ensuring consistent manufacturing performance.
Key Responsibilities:- Performing routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).
- Supporting manufacturing operations by responding to system‑related issues, troubleshooting instrument performance, and documenting observed problems.
- Assisting in the investigation of unplanned equipment events using structured problem‑solving tools and contributing to root cause assessments.
- Conducting equipment health monitoring and contributing to reliability improvement activities to increase system uptime.
- Executing planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.
- Reviewing and interpreting instrument data to identify basic trends or abnormalities.
- Supporting adherence to data integrity principles and helping maintain data consistency within systems such as Smartline Data Cockpit.
- Collaborating with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.
- Assisting with documentation updates, tracking of work activities, and preparing technical summaries as needed.
- Working independently to accomplish assigned tasks while keeping stakeholders informed of progress.
Experience:
- B.S., M.S., or Ph.D in an engineering or analytical/scientific discipline.
- Prior hands‑on experience with analytical systems is required.
- Experience using cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) in GMP Manufacturing or QC Labs preferred.
- Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.
- General understanding of biotech analytical methods and laboratory practices.
- Experience troubleshooting analytical instruments and interpreting equipment performance data.
- Flexibility in problem solving and work hours to meet business objectives.
- Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.
- 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.
- Strategic thinking mindset with the ability to convert system needs into actionable activities.
- Builds productive relationships with partners; focuses on customer needs.
For information on benefits, equal opportunity employment, and location‑specific applicant notices,
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.
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