Manufacturing Engineer II - Front Line Engineering

Lonza; Vacaville (CA); On-site; Confidential; Full time

Job summary

Lonza is seeking a Manufacturing Engineer II - Front Line Engineering in Vacaville, CA, a fully site-based role supporting upstream manufacturing and associated systems. You will act as the floor-level SME for equipment including media prep, CIP skids, autoclaves, and large-scale bioreactors, ensuring GMP compliance and readiness across MAR operations.

The role emphasizes rapid troubleshooting, RCAs, data-driven reliability improvements, and collaboration across engineering, maintenance, and

Qualifications

• Degree in engineering or related field with GMP awareness.
• Formal root cause analysis training and experience leading RCAs.
• Strong communication, writing, and teamwork skills.
• Proficiency with MS Office, SAP, P&IDs; data trending, analysis, and reporting.

Responsibilities

• Triage, troubleshoot, and resolve equipment failures on the manufacturing floor, escalating as needed.
• Lead formal RCA investigations for operational events using structured methods.
• Monitor equipment performance, analyze data, and identify trends to improve uptime and throughput.
• Implement equipment upgrades, modifications and process improvements via engineering change control.
• Assess impacts of unplanned disruptions against validated process requirements and drawings.
• Support capital projects and tech transfers by preparing URS, reviewing designs, and executing IQ/OQ.
• Provide on‑call 24/7 technical support for urgent plant-floor issues.

Skills

GMP knowledge

Root cause analysis

Data trending/analysis

Communication skills

Teamwork

MS Office

Project management

Technical troubleshooting

Education

Bachelor of Science in Engineering

Tools

SAP

P&IDs

Job description

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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.