Manufacturing Engineer II - Front Line Engineering

Location: Vacaville, California

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

As a Manufacturing Engineer II - Front Line Engineering, you serve as the direct floor-level technical owner and subject matter expert (SME) for the Upstream manufacturing and support systems, including Media Prep and Hold, Clean-in-Place skids, Washers and Autoclaves, Seed Train Operations (Thaw through N-4 stage bioreactors), Large Scale Bioreactors, Process Analytical Technology (PAT), and Harvest / Centrifuge.

In this role you will ensure production equipment and systems remain fit-for-purpose, compliant, and ready for use across all make, assess, and release (MAR) operations. Operating with moderate supervision, you bridge engineering, maintenance, and plant operations to maximize uptime, resolve urgent equipment excursions, and maintain strict GMP compliance.

What you will get

The full-time base annual salary for this position is expected to range between $93,000 to $155,000. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance, as well as short-term and long-term disability insurance
• Employee assistance programs
• Paid Time Off

What you will do

• Rapidly triage, troubleshoot, and resolve routine mechanical, electrical, and automation equipment failures independently, collaborating with senior engineering for complex or recurring breakdowns.
• Lead formal root cause analysis investigations for complex operational events using structured methodologies such as 5 Whys, Ishikawa fishbone diagrams, Kepner-Tregoe, and FMEA.
• Monitor equipment performance metrics, analyze operational data, and identify trends to drive reliability, decrease downtime, and improve throughput.
• Formulate and implement equipment upgrades, modifications, and process improvements through formal engineering change control procedures.
• Evaluate the operational and quality impacts of unplanned equipment disruptions against validated process requirements and engineering drawings.
• Support capital projects and new technology transfers by developing User Requirements Specifications (URS), participating in design reviews, and executing commissioning and qualification (IQ/OQ).
• Provide on-call 24/7 technical support to resolve urgent plant-floor manufacturing and equipment issues as scheduled.

What we look for

• Bachelor of Science degree in Engineering or related field.
• Sound knowledge of Good Manufacturing Practices (GMPs) as they relate to biopharmaceutical manufacturing facilities and operations.
• Strong technical understanding of common biopharmaceutical drug substance manufacturing unit operations; operational experience preferred.
• Formal root cause analysis training and significant experience leading RCAs.
• Excellent interpersonal, communication, writing, problem solving and teamwork skills.
• Proficiency with MS Office, SAP, P&IDs; data trending, analysis, reporting and visualization skills.
• Proven small to medium project management and execution experience.