Associate Engineer

Summary

This position is located at Lonza’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 the downstream equipment systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility.

In this role, you will directly support manufacturing activities (aka make, assess, and release or MAR) by aiding the system subject matter experts (SME). You will be responsible for aiding in investigating and assessing unplanned events, managing planned system changes, and executing/supporting capital projects. You will partner with a cross functional team including Manufacturing, Process Engineering, Maintenance, System Owners, Automation, SHE, and Quality Assurance. You will use technical knowledge and your understanding of GMP systems to aid in identifying and solving problems, make and influence decisions, and deliver results.

Job Responsibilities

Responsibilities/activities may include, but not limited to:

·       Directly support manufacturing activities as an equipment/system subject matter expert (SME), ensuring assigned systems are ready for use.

·       Investigate and assess complex unplanned events, manage planned system changes, and lead small to medium-sized improvement projects.

·       Partner with teams, including Manufacturing, Process Engineering, Maintenance, System Owners, Automation, SHE, and Quality Assurance, to realize the production schedule.

·       Use in-depth technical knowledge, project leadership skills, and sophisticated understanding of GMP systems to identify and solve complex problems, make and influence decisions, and deliver results.

·       Own/support one or more of the following systems: Buffer/Media Prep and Hold, Clean-in-Place skids, Washers and Autoclaves, Seed Train Operations, Bioreactors, Process Analytical Technology, Harvest/Centrifuge, Chromatography, Viral Filtration System, Ultrafiltration/Diafiltration, Freeze/thaw skids, Bulk Dispensing Operations.

·       Provide in-depth SME support for manufacturing equipment/systems including: startup, commissioning, and qualification of new equipment, providing 24/7 on-call support as assigned.

Job Requirements

Education and Experience:

·       B.S., M.S. in an engineering scientific discipline.

Knowledge/Skills/Competencies:

·       Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.

·       Flexibility in problem solving and work hours to meet business objectives.

·       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.

Work Environment/Physical Demands/Safety Considerations

This role reports functionally and organizationally into the Sr. Manager DSFL

This role requires:

·       Working on the manufacturing floor around production-related equipment.

·       Interacting with highly regulated environments and adhering to all data integrity and GMP requirements.

·       Gowning to enter classified spaces when needed.

·       Following all environmental, health, and safety procedures.

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