Manufacturing Engineer II - Front Line Engineering

Lonza Group Ltd.; Vacaville (CA); On-site; USD 93,000 - 155,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short- and long-term disability

Job summary

Lonza Group Ltd. is seeking a Manufacturing Engineer II - Front Line Engineering for a fully on-site role in Vacaville, California. You will be the floor-level SME across Upstream systems, ensuring equipment stays fit-for-purpose, compliant and available for MAR operations.

You will lead RCAs, monitor performance, drive improvements, and support capital projects; collaborate with engineering, maintenance and operations in a GMP biopharma setting.

Qualifications

• Bachelor of Science degree in Engineering or related field.
• Sound knowledge of GMPs in biotech manufacturing facilities.
• Formal RCAs training and experience leading RCAs.
• Proficiency with MS Office, SAP, P&IDs; data trending, analysis, reporting and visualization.

Responsibilities

• Triage and troubleshoot mechanical, electrical, and automation issues.
• Lead formal RCAs using structured methods (5 Whys, fishbone, Kepner-Tregoe, FMEA).
• Monitor equipment performance, analyze data, and drive reliability and throughput improvements.
• Implement equipment upgrades and process changes via engineering change control.
• Support capital projects and tech transfers with URS, design reviews, IQ/OQ.

Skills

RCA training

GMP knowledge

MS Office

Data analysis

Data visualization

Reporting

Project management

Communication

Teamwork

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.

Every day, our teams across the world work together to turn scientific breakthroughs into life‑changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong. You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility.
• Love solving problems and thrive in a complex, fast‑moving environment.
• Are curious, always looking to learn and improve.
• Work collaboratively, contributing to something bigger than yourself.
• Are motivated to make a difference through work that impacts customers and their patients.

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow.

Join us. Be you.