Manufacturing Engineer II - Front Line Engineering

Lonza•Vacaville, CA

8d•Onsite

About The Position

The Manufacturing Engineer II - Front Line Engineering is 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, this position bridges engineering, maintenance, and plant operations to maximize uptime, resolve urgent equipment excursions, and maintain strict GMP compliance. The role is based fully on site in Vacaville, California, and includes scheduled 24/7 on-call technical support. Lonza describes its globally connected teams, values of Collaboration, Accountability, Excellence, Passion, and Integrity, and commitment to equal employment opportunity. The expected full-time base annual salary is $93,000 to $155,000, with additional benefits described below.

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.
Strong technical understanding of common biopharmaceutical drug substance manufacturing unit operations.
Formal root cause analysis training and significant experience leading root cause analyses.
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.

Responsibilities

Rapidly triage, troubleshoot, and independently resolve routine mechanical, electrical, and automation equipment failures; collaborate with senior engineering on complex or recurring breakdowns.
Lead formal root cause analysis investigations for complex operational events using methods such as 5 Whys, Ishikawa fishbone diagrams, Kepner-Tregoe, and FMEA.
Monitor equipment performance metrics, analyze operational data, and identify trends to improve reliability, decrease downtime, and increase 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.