Manufacturing Engineer II - Front Line Engineering

Lonza
  • Vacaville, California
    3 days ago

    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.

     

    Ready to shape the future of life sciences? Apply now.

     

    Numbers & Facts

    LocationVacaville, California

    Skills

    • Autoclaveunmatched
    • Automationunmatched
    • Biologyunmatched
    • Bridge Buildingunmatched
    • CIP (Clean-in-Place)unmatched
    • Capital Projectunmatched
    • Centrifugeunmatched
    • Change Controlunmatched
    • Civil Engineeringunmatched
    • Commissioningunmatched
    • Communication Skillsunmatched
    • Data Analysisunmatched
    • Dental Insuranceunmatched
    • Drug Manufacturingunmatched
    • Electrical Componentsunmatched
    • Employee Assistance Planunmatched
    • Engineering Change Managementunmatched
    • Engineering Drawingunmatched
    • Equal Employment Opportunity (EEO)unmatched
    • Failure Mode and Effects Analysis (FMEA)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Identify Issuesunmatched
    • Interpersonal Skillsunmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing Equipment Maintenanceunmatched
    • Manufacturing Operationsunmatched
    • Manufacturing Systemsunmatched
    • Medical Productsunmatched
    • Microsoft Officeunmatched
    • On Callunmatched
    • Operational Auditunmatched
    • Performance Analysisunmatched
    • Performance Metricsunmatched
    • Problem Solving Skillsunmatched
    • Process Analysisunmatched
    • Process Engineeringunmatched
    • Process Improvementunmatched
    • Process Validationunmatched
    • Production Systemsunmatched
    • Project Executionunmatched
    • Project/Program Managementunmatched
    • Requirements Managementunmatched
    • Requirements Validation/Verificationunmatched
    • Root Cause Analysisunmatched
    • SAPunmatched
    • Safety Standardsunmatched
    • Team Playerunmatched
    • Technical Supportunmatched
    • Trend Analysisunmatched
    • Vision Planunmatched

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