Process Engineer I

Company: Tailored Management
Location: Vacaville
Posted on: March 4, 2026

Job Description:

Job Title: Process Engineer I Location: 1000 New Horizons Way, Vacaville, CA 95688 Duration: 6-Month Contract (Potential Extension or Conversion) Pay Rate: $21.87 $36.46/hour (W2) Benefits: Weekly Pay | Medical, Dental & Vision Coverage Position Summary This position is based at Lonzas biopharmaceutical manufacturing facility in Vacaville, California, where pharmaceutical proteins are produced using large-scale mammalian cell culture technologies. The Process Engineer I will provide hands-on technical support for Process Analytical Technology (PAT) systems operating on the GMP manufacturing floor. PAT systems are essential for monitoring critical cell culture parameters such as cell density, viability, and metabolite concentrations to ensure consistent manufacturing performance. This role supports daily operation, maintenance, troubleshooting, and continuous improvement of PAT instrumentation used in upstream manufacturing processes. The selected candidate will collaborate closely with the Frontline Upstream (FLUS) System Owner, Manufacturing teams, and Instrumentation personnel to evaluate system performance, perform equipment health assessments, execute planned upgrades, and support investigations related to unplanned equipment events. This opportunity offers practical exposure to advanced analytical technologies supporting mammalian cell culture and purification operations within a large-scale biopharmaceutical environment. Key Responsibilities Responsibilities include, but are not limited to: Perform routine maintenance, calibration verification, and system readiness checks for PAT instruments, including cell counters and metabolite analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas). Provide real-time manufacturing support by troubleshooting instrument performance issues and documenting observations. Assist in investigations related to equipment deviations using structured problem-solving methodologies and support root cause analysis activities. Conduct equipment health monitoring and contribute to system reliability and uptime improvement initiatives. Execute minor equipment upgrades, configuration updates, and planned system changes under guidance from the PAT System Owner. Review and interpret analytical instrument data to identify trends, deviations, or performance abnormalities. Support data integrity practices and maintain consistency within data management platforms such as Smartline Data Cockpit. Collaborate with Manufacturing, FLUS, Automation, Quality Assurance, and external vendors to ensure optimal system performance. Assist with technical documentation updates, activity tracking, and preparation of operational summaries. Independently manage assigned tasks while maintaining regular communication with stakeholders. Education & Experience Bachelors, Masters, or Ph.D. degree in Engineering, Biotechnology, or a related scientific discipline. Hands-on experience with analytical instrumentation is required. Experience operating cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) within GMP Manufacturing or QC laboratory environments is preferred. Required Skills & Competencies Working knowledge of current Good Manufacturing Practices (cGMP) within biopharmaceutical or regulated manufacturing environments. Understanding of biotech analytical methods and laboratory practices. Experience troubleshooting analytical instruments and evaluating equipment performance data. Familiarity with data management systems; Smartline Data Cockpit experience is highly preferred. Strong analytical, problem-solving, and technical troubleshooting skills. Effective verbal and written communication skills, including technical documentation and reporting. Ability to work independently with minimal supervision while managing multiple priorities. Strong interpersonal skills with the ability to collaborate across cross-functional teams and vendors. Demonstrated ability to assess technical issues, recommend solutions, and implement corrective actions. Customer-focused mindset with strong relationship-building capabilities. TMN

Keywords: Tailored Management, San Bruno , Process Engineer I, Engineering , Vacaville, California