Director, Automation Engineering

Ultragenyx Pharmaceutical•Bedford, MA

1d•Onsite

About The Position

At Ultragenyx, we are driven by a mission to lead the future of rare disease medicine. We challenge the status quo by developing innovative treatments and creating a collaborative ecosystem to reach patients effectively. Our commitment extends to our people, fostering a supportive and inclusive environment for profound learning and growth. We aim to be an organization where employees can thrive, do their best work, and grow professionally and personally, making a meaningful impact on rare disease patients.

Requirements

Bachelor’s degree in chemical, Electrical, Mechanical, Biomedical Engineering, or Computer Science with appropriate industrial controls experience.
10+ years of experience in a manufacturing support environment, as a system integrator or automation engineer.
5+ years of Management experience preferred.
Proficiency in PLC and DCS coding, installation, and support, including but not limited to Allen Bradley, Siemens, and DeltaV.
Understanding and configuration of systems such as PI, Win-911, and InfoBatch.
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 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.
Ability to effectively manage the automation lifecycle of controls components.
Familiarity with bioprocessing systems for Drug Substance and Drug Product manufacturing.

Nice To Haves

5+ years of Management experience

Responsibilities

Oversees the automation engineering team’s day to day operations and metrics.
Ensures that manufacturing & facilities equipment is functional and fit for its intended use.
Ensures operations are supported, and that troubleshooting and process improvements are implemented with a quality mindset.
Serves as the Business System Owner for the site’s automation systems: the Qualified Monitoring and Alarm System (QMAS), the site Process Automation System (PAS), the Historical Data system PI, and the Building Monitoring System (BMS).
Develops an Automation Roadmap that encourages continuous improvement through the identification and implementation of new ideas that positively impact a segment or area of the organization and its overall performance.
Evaluates new technologies for their application in GMP manufacturing facility.
Collaborates with IT and other internal and external partners to resolve issues and improve site performance.
Drives all automation strategies and deliverables independently with limited to no direct supervision or technical oversight required.
Represents automation systems and programs to worldwide regulatory agencies.
Presents to and solicits alignment from senior leadership on both known and unknown challenges/problems.
Provides technical solutions to a wide range of process, building, and networking challenges associated with automated systems.
Acts as a subject matter expert in all site automation systems.
Programs, configures, and integrates equipment into the site OT Network, QMAS, and BMS systems.
Develops, reviews, and approves engineering documentation including equipment specifications, test protocols, engineering standards, and procedures.
Supports the Manufacturing facility and QC Laboratory with regards to automation and instrumentation requirements.
Participates in cross-functional teams created to perform investigations, root cause analysis, CAPA creation or improvement opportunities as needed.
Ensures that all required training is completed on time and current.
Manages employees and contract staff.
Manages contracts/SOWs, purchase orders, and budgets for automation support & initiatives.
Establishes operational objectives and work plans and reviews objectives to determine success of the Automation Engineering department.
Participates with other senior managers to establish plans and objectives and makes decisions on operational matters.