The Staff Process Development Engineer - Mechanical Engineering is part of the sustaining technical operations engineering team who provides expertise, service, and support to San Diego Illumina headquarters by maintaining and improving fill processes and equipment of consumables at world class levels in a fast pace regulated environment. The Staff Process/ Equipment Engineer maintains sustaining equipment and processes to provide high level reliability exceeding Illumina’s dynamic development and manufacturing demands. The Staff engineer will support the day-to-day manufacturing operations by owning components of a subsystem and its process, with oversight. This individual will work in a dynamic team- oriented environment that supports multiple operations and on-market technologies helping Illumina deliver its highly complex product pipeline in a reliable and sustainable manner.
Responsibilities:
Process and Equipment owner of a manufacturing system or multiple components of a large manufacturing system with oversight.
Use process data, mechanical, electrical, and/or fluidics tools, and knowledge to perform equipment and process troubleshooting.
Work in a team environment to develop creative solutions to improve process and equipment reliability.
Contributes to investigation and resolution of technical problems for on-market products, including providing supporting data on risks/issues and recommendations for improvement in area of responsibility and at critical interfaces to other cross- functional teams.
Investigate nonconformances and develop long term solutions.
Understand basic internal instrument communication (RS232, PLC, IO)
Influences decisions in own area of responsibility.
Able to plan, prioritize, coordinate, and execute multiple parallel activities like process improvement projects, supplier support, sustaining issues, and new product introduction project activities with minimal guidance from manager.
Generate or revise standard operating procedures/work instructions, troubleshooting guides and checklists for new fill lines. Create or modify applicable maintenance plans to maintain equipment uptime for new fill lines.
Able to define requirements and select appropriate components and vendors in area of responsibility, without oversight.
Work with vendors as required to improve support for manufacturing fill lines.
Able to track COGS and associated project expenses.
While performing the duties of this job, is regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear. Must regularly lift and / or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs
Requirements:
Ability to troubleshoot various equipment and process failures.
Ability to operate in a fast-paced environment, adapt to changes in priority, and redirect efforts as necessary.
Advanced data collection (R, Python, shell/batch), hands-on skills and ability to summarize results.
Must be familiar with Programmable Logic Controllers, Distributed Control Systems, and various SCADA packages.
Ability to communicate and document process and equipment failures and resolutions to stakeholders.
Demonstrated continuous improved performance of processes and equipment
Experience with Beckhoff TwinCAT, Siemens TIA Portal, and Rockwell RSLogix 5000 would be an advantage plus
Experience with electrical and mechanical schematics
Excellent technical and computer troubleshooting skills
Fundamental knowledge of mechanical/electrical/fluidic systems
Experience with drafting and executing validation protocols is a plus
Experience working on laboratory equipment preferred
Work experience in Life Sciences / Pharmaceutical / Medical Devices industries would be an advantage
Knowledge of GMP (Good Manufacturing Practice) would be a plus
Travel up to 10%
Educational Requirements:
Typically requires a bachelor’s degree and a minimum of 8+ years of related experience in mechanical/ controls engineering roles is preferred; or an advanced degree with 5+ years or equivalent work experience is preferred.