Onsite Frontline Biopharma Manufacturing Engineer II

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

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