Manufacturing Engineer II - Front Line Engineering

Lonza•Vacaville, CA

10d•$93,000 - $155,000•Onsite

About The Position

The Manufacturing Engineer II - Front Line Engineering serves as the direct floor-level technical owner and subject matter expert for Upstream manufacturing and support systems, including Media Prep and Hold, Clean-in-Place skids, Washers and Autoclaves, Seed Train Operations from thaw through N-4 stage bioreactors, Large Scale Bioreactors, Process Analytical Technology (PAT), and Harvest / Centrifuge. The role ensures production equipment and systems remain fit-for-purpose, compliant, and ready for use across make, assess, and release (MAR) operations. Operating with moderate supervision, the engineer bridges engineering, maintenance, and plant operations to maximize uptime, resolve urgent equipment excursions, and maintain GMP compliance. The position is fully site-based in Vacaville, California, and provides scheduled 24/7 on-call technical support. The full-time base annual salary is expected to range from $93,000 to $155,000, in addition to the listed benefits.

Requirements

Bachelor of Science degree in Engineering or a related field.
Sound knowledge of Good Manufacturing Practices (GMPs) as they relate to biopharmaceutical manufacturing facilities and operations.
Excellent interpersonal, communication, writing, problem-solving, and teamwork skills.
Proficiency with MS Office, SAP, and P&IDs.
Data trending, analysis, reporting, and visualization skills.
Proven small- to medium-sized project management and execution experience.

Nice To Haves

Operational experience with common biopharmaceutical drug substance manufacturing unit operations is preferred.
Formal root cause analysis training and significant experience leading RCAs.

Responsibilities

Independently triage, troubleshoot, and resolve routine mechanical, electrical, and automation equipment failures, collaborating with senior engineering on 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, identify trends, and drive reliability, reduced downtime, and improved 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 scheduled 24/7 on-call technical support for urgent plant-floor manufacturing and equipment issues.