Senior Automation Engineer I

Ultragenyx Pharmaceutical•Bedford, MA

1d•Onsite

About The Position

ultra impact – Make a difference for those who need it most The Senior Automation Engineer I plays a critical role in the design, implementation, commissioning, qualification, and ongoing support of the Operational Technology (OT) network that enables process, building, and equipment control systems. This role leads Automation activities during technology transfers, supports daily operations, resolves technical issues, and drives continuous improvement initiatives. Key responsibilities include identifying essential interfaces between the OT network and process/building systems; interpreting P&IDs, wiring diagrams, facility and equipment drawings, and specifications to develop effective automation strategies for GMP manufacturing; and performing hands-on troubleshooting and repairs.

Requirements

Required education: Bachelor’s degree in chemical, Electrical, Mechanical, Biomedical Engineering, or Computer Science with appropriate industrial controls experience.
6+ years of experience in manufacturing GxP support environment, as a system integrator or automation engineer.
PLC and DCS coding, installation, and support, including but not limited to Ignition, Allen Bradley, Siemens, and DeltaV.
Understanding and configuration of systems such as PI, Kepware, Win-911, and Wonderware.
Experience with BMS systems (Delta Controls preferred).
Experience with analytical equipment such as balances, pH/DO meters, Nova FLEX2, Beckman Coulter Vi-CELL, filter integrity testers, etc.
Understanding of control instrumentation, electrical, and wiring standards.
Understanding of network architecture, including firewall and switch configuration and virtualized environments.
Familiarity with industry standard communication protocols such as Ethernet IP, PROFINET, Modbus TCP, OPC, and BACnet.
Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures.
Adherence to domestic and international GMP regulations.
Experience with data integrity, specifically the understanding of FDA Part 11 and European Annex 11 requirements and experience applying these standards to the qualification of automation systems.
Able to effectively manage the automation lifecycle of controls components.
Familiarity with bioprocessing systems for Drug Substance and Drug Product manufacturing.
Stand for extended periods of time wih periodic stooping / bending / kneeling.
Ability to climb ladders and stairs of various heights.
Able to lift, push, pull up to 50lbs.
Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
Certain tasks may require use of a respirator; medical clearance will be required in advance.
Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment.
Working in termperature-controled environments (cold rooms).

Responsibilities

Strategic Focus Areas: a. Lead tech transfer activities to implement parameter changes, alarm changes, graphic/logic changes and historical data changes. b. Collaborate with Process Engineering to implement operational improvements, upgrades and bringing new systems online. c. Collaboratively work with IT, Facilities, EHS, area BSO’s and other internal and external partners to resolve issues and improve site performance.
This job requires a level of technical proficiency in multiple skill areas and the ability to interpret complex information to solve problems. It also requires a service provider mindset that supports a variety of customers within Manufacturing, Engineering, Facilities, Validation, QC, etc.
Provide technical solutions to a wide range of process, building, and networking challenges associated with automated systems.
Collaboratively work with IT and other internal and external partners to resolve issues on cybersecurity and maintain data integrity compliance.
Subject matter expert in all site automation systems.
Program, configure, and integrate equipment into the site OT Network, QMAS, and BMS systems.
Develop, review, and approve engineering documentation including specifications, test protocols, preventative maintenance, and audit trail reviews.
Support development of engineering standards and procedures.
Support the Manufacturing facility and QC Laboratory with regards to automation and instrumentation requirements.
Own change controls to implement both minor and major site changes to automation systems.
Own deviations to perform investigations, root cause analysis, CAPA creation or improvement opportunities as needed.
Ensure that all required training is completed on time and current.
Support off hours on-call rotation.
May oversee contract staff.
May oversee contracts/SOWs, purchase orders, budgets for automation support & initiatives.