Process Engineer I

Hi

Greeting from Ageatia Global Solutions. We have a new job opening with my direct client.
Please go through the Job Description and if you are comfortable and available in the job market, then pl reply to me.

Job Title: Process Engineer
Duration: 09 Months
Location: Vacaville, CA-95688

Summary:
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.
In this role, you will support day-to-day operation, maintenance, and troubleshooting and repair of PAT instruments used in GMP manufacturing. You will work closely with the Frontline Upstream (FLUS) 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 increased workload associated with the deployment of several new PAT systems in parallel with existing instruments. This position offers the opportunity to gain hands-on experience with advanced PAT used to support mammalian cell culture and purification operations. The FLUS and Instrumentation groups provide technical support for a wide range of analytical instruments used to monitor cell growth, metabolite profiles, and process performance throughout the manufacturing lifecycle.

Job Duties:
Responsibilities/activities may include, but not limited to:

• 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.

Education and 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.
• Knowledge/Skills/Competencies:
• 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.