Staff Engineer, Automation Systems

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Position Summary

MTT (Manufacturing Technology & Transfer) works as an integral part of our Consumables Development and Manufacturing teams and is tasked with developing and deploying consumables manufacturing processes within our production environments.

The Staff, Automation Systems Engineer serves an important role in the MTT to support the development of tools/automated equipment and processes from the prototype phase to full scale production. The role will collaborate with consumable Development teams, Reagent, Substrate & Oligo Production, Assembly Manufacturing, EHS, Facilities, Supply Chain, Strategic Sourcing, and Quality assurance to develop Automated Manufacturing processes to support the launch of new products and provide solutions to upgrade existing manufacturing infrastructure. The position will require a creative problem solver to evaluate and deploy new automation technology through proof-of-concept testing, feasibility evaluation, systems engineering controls, verification, characterization, and validation of solutions in an FDA regulated GMP environment.

Responsibilities

• Identify and scope out intended use, detailed requirements for automation equipment, and evaluate internally and the marketplace for possible solutions for complex, SCADA integrated automation (modification, OTS, internal/external design)
• Execute against a proper systems engineering framework similar to those found in pharmaceuticals, medical device, IVD, and defense when bringing in automated equipment
• Lead/Collaborate with engineering teams to define transfer and scale-up of manufacturing, define system requirements, RFPs, system specifications, verification test plans, and support of validation activities
• Collaborate with internal Design, Process, and Automation teams and evaluate tradeoffs between external and internal distribution of work
• Functions as a central resource with Design, Process, Development, Test, Quality, EHS, Strategic Sourcing, and Manufacturing cross-functional teams as equipment moves through its lifecycle
• Conduct project management, creation and maintenance of detailed project plans, schedules, and budgets for team members, provide status reports, and make presentations on progress
• Guide and collaborate with vendors and engineering contractors when necessary to deliver solutions on time, with quality, and within budget
• Serve as the system lead during commissioning (FAT, SAT), onboarding, characterization and validation (IQ/OQ/PQ) activities
• Lead onboarding activities that include, but are not limited to, facilities coordination, install, and assessments, EHS assessments, critical spares management, calibrated component management, and validation support
• Utilize expertise in 6-sigma, DFSS, 8D, DMAIC to solve issues that arise during equipment bring up and process development phases of new product introductions
• Mentor and guide junior engineers with systems engineering excellence
• 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

• Possess strong engineering fundamentals with relevant experience in automation systems engineering, design, development, verification, delivery, onboarding, and validation/qualification
• Working experience in highly collaborative cross-functional and matrixed organizations
• Prior experience in verification and troubleshooting of equipment mechanics, electrical, pneumatics, and controls automation components
• Trade off analysis of automation technology selection and troubleshooting
• Experience with servo-driven systems, robotics, controllers, and vision systems
• Experience with mechanical drawings, electrical layouts, P&IDs, and process flows
• Exposure using PLC and HMI development software and troubleshooting
• Basic knowledge network communications and topology
• Excellent technical writing, presentation, and oral communication skills
• Ability to multi-task, stay organized,