Senior Equipment Engineer

Lonza•Bend, OR

About The Position

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits What you will do: Responsible for technical ownership, troubleshooting, and continuous improvement of pharmaceutical process equipment, with a primary focus on spray dryers and solid oral dosage (tablet) manufacturing equipment. Provide hands-on engineering support to manufacturing operations, reliability, and quality teams, ensuring equipment performance, compliance, and product quality. Provides equipment downtime response, analysis and troubleshooting for critical cGMP manufacturing equipment and systems, including mechanical, process, automation, and electrical issues. Assist with required project activities including attending regular internal/external personnel meetings, reviewing meeting minutes, action item log, owner/architect/contractor (OAC) meeting, design reviews, schedule and cost reviews, change orders, constructions progress walks, safety toolbox talks, and construction permits. Practices safety awareness at all times and considers impact of actions prior to executing activities. Process & Equipment Engineering Serve as the subject matter expert (SME) for process equipment, including spray dryers, granulation, blending, compression, and ancillary tablet manufacturing systems. Troubleshoot complex equipment and process issues using structured problem-solving and root cause analysis techniques. Diagnose mechanical, process, and control-related failures in a safe manner and recommend corrective and preventive actions. Support equipment lifecycle management, including upgrades, obsolescence planning, and performance optimization. Partner with the Reliability team to improve equipment uptime, reliability, and maintainability. Assists with ensuring state of the art technologies, and industry and safety standards are evaluated and utilized to incorporate innovations into process, equipment, automation, and OT designs. Assists with ensuring process and automation engineering solutions maximize and optimize process efficiency, and improve quality of performance for manufacturing processes. Manufacturing Support Provide on-the-floor engineering support during manufacturing operations, startups, shutdowns, and process changes. Assists maintenance with manufacturing equipment and systems downtime response, analysis and troubleshooting, including coordination with vendors and contractors. Support deviation investigations by identifying root causes, defining corrective actions, and authoring technical sections of deviation reports. Support change management activities, including impact assessments and implementation of process or equipment changes. Train manufacturing operator and equipment specialists on equipment operations, process changes, and troubleshooting best practices. Documentation & Project Support Author and review User Requirement Specifications (URS) for new or modified process equipment. Interacts with internal customers to ensure scopes and URSs are evaluated and prepared with site process, equipment, automation, and OT capabilities to support the user requirements for requested projects. Interact with internal and external engineering design teams and vendors to prepare functional requirement specifications (FRSs), functional design specifications (FDSs), and detailed design specifications (DDSs) to ensure the facility, process and equipment capabilities can support the URSs. Review and approve equipment specifications, drawings, FAT/SAT documentation, and vendor technical packages. Support capital projects from concept through commissioning and qualification (as applicable). Ensure documentation is accurate, complete, and aligned with GMP and data integrity requirements. Quality & Compliance Ensure equipment design and operation meet regulatory, safety, and quality standards. Support audits and inspections by providing technical expertise and documentation as needed. Perform regulatory compliance, quality, and change management tasks. Assist with developing and revising facility and utility standard operating procedures (SOPs), and reviewing predictive and preventive maintenance. Assist with ensuring project process, equipment, automation, and OT designs, installations, operations, and operating procedures are in compliance with appropriate industry and regulatory standards.

Requirements

High School Diploma/GED required.
Bachelor of Science in Mechanical, Chemical, or Electrical Engineering preferred.
10+ years experience in the biotechnology/pharmaceutical industry.
Experience supporting capital equipment projects.
Familiarity with reliability engineering principles (RCM, FMEA, MTBF, etc) as well as diagnosing manufacturing equipment.
Experience working directly with external clients.
Knowledge of automation, controls, or data systems related to process equipment.
Proficient with Microsoft Office Suite as well as Autodesk Vault, AutoCAD, and Revit 3D Model.
Strong collaboration and customer-focused mindset with ability to work in a highly matrixed and diverse business environment.
Effective at presenting information and ideas formally and informally, and verbally and in writing to others in a manner that facilitates understanding.

Responsibilities

Responsible for technical ownership, troubleshooting, and continuous improvement of pharmaceutical process equipment, with a primary focus on spray dryers and solid oral dosage (tablet) manufacturing equipment.
Provide hands-on engineering support to manufacturing operations, reliability, and quality teams, ensuring equipment performance, compliance, and product quality.
Provides equipment downtime response, analysis and troubleshooting for critical cGMP manufacturing equipment and systems, including mechanical, process, automation, and electrical issues.
Assist with required project activities including attending regular internal/external personnel meetings, reviewing meeting minutes, action item log, owner/architect/contractor (OAC) meeting, design reviews, schedule and cost reviews, change orders, constructions progress walks, safety toolbox talks, and construction permits.
Practices safety awareness at all times and considers impact of actions prior to executing activities.
Serve as the subject matter expert (SME) for process equipment, including spray dryers, granulation, blending, compression, and ancillary tablet manufacturing systems.
Troubleshoot complex equipment and process issues using structured problem-solving and root cause analysis techniques.
Diagnose mechanical, process, and control-related failures in a safe manner and recommend corrective and preventive actions.
Support equipment lifecycle management, including upgrades, obsolescence planning, and performance optimization.
Partner with the Reliability team to improve equipment uptime, reliability, and maintainability.
Assists with ensuring state of the art technologies, and industry and safety standards are evaluated and utilized to incorporate innovations into process, equipment, automation, and OT designs.
Assists with ensuring process and automation engineering solutions maximize and optimize process efficiency, and improve quality of performance for manufacturing processes.
Provide on-the-floor engineering support during manufacturing operations, startups, shutdowns, and process changes.
Assists maintenance with manufacturing equipment and systems downtime response, analysis and troubleshooting, including coordination with vendors and contractors.
Support deviation investigations by identifying root causes, defining corrective actions, and authoring technical sections of deviation reports.
Support change management activities, including impact assessments and implementation of process or equipment changes.
Train manufacturing operator and equipment specialists on equipment operations, process changes, and troubleshooting best practices.
Author and review User Requirement Specifications (URS) for new or modified process equipment.
Interacts with internal customers to ensure scopes and URSs are evaluated and prepared with site process, equipment, automation, and OT capabilities to support the user requirements for requested projects.
Interact with internal and external engineering design teams and vendors to prepare functional requirement specifications (FRSs), functional design specifications (FDSs), and detailed design specifications (DDSs) to ensure the facility, process and equipment capabilities can support the URSs.
Review and approve equipment specifications, drawings, FAT/SAT documentation, and vendor technical packages.
Support capital projects from concept through commissioning and qualification (as applicable).
Ensure documentation is accurate, complete, and aligned with GMP and data integrity requirements.
Ensure equipment design and operation meet regulatory, safety, and quality standards.
Support audits and inspections by providing technical expertise and documentation as needed.
Perform regulatory compliance, quality, and change management tasks.
Assist with developing and revising facility and utility standard operating procedures (SOPs), and reviewing predictive and preventive maintenance.
Assist with ensuring project process, equipment, automation, and OT designs, installations, operations, and operating procedures are in compliance with appropriate industry and regulatory standards.