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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.
Work Model:Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:1. 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.
2. 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.
3. Provide technical solutions to a wide range of process, building, and networking challenges associated with automated systems.
4. Collaboratively work with IT and other internal and external partners to resolve issues on cybersecurity and maintain data integrity compliance.
5. Subject matter expert in all site automation systems.
6. Program, configure, and integrate equipment into the site OT Network, QMAS, and BMS systems.
7. Develop, review, and approve engineering documentation including specifications, test protocols, preventative maintenance, and audit trail reviews.
8. Support development of engineering standards and procedures.
9. Support the Manufacturing facility and QC Laboratory with regards to automation and instrumentation requirements.
10. Own change controls to implement both minor and major site changes to automation systems.
11. Own deviations to perform investigations, root cause analysis, CAPA creation or improvement opportunities as needed.
12. Ensure that all required training is completed on time and current.
13. Support off hours on-call rotation.
14. May oversee contract staff.
15. May oversee contracts/SOWs, purchase orders, budgets for automation support & initiatives.
Requirements:1. Required education: Bachelor’s degree in chemical, Electrical, Mechanical, Biomedical Engineering, or Computer Science with appropriate industrial controls experience.
2. 6+ years of experience in manufacturing GxP support environment, as a system integrator or automation engineer.
3. PLC and DCS coding, installation, and support, including but not limited to Ignition, Allen Bradley, Siemens, and DeltaV.
4. Understanding and configuration of systems such as PI, Kepware, Win-911, and Wonderware.
5. Experience with BMS systems (Delta Controls preferred).
6. Experience with analytical equipment such as balances, pH/DO meters, Nova FLEX2, Beckman Coulter Vi-CELL, filter integrity testers, etc.
7. Understanding of control instrumentation, electrical, and wiring standards.
8. Understanding of network architecture, including firewall and switch configuration and virtualized environments.
9. Familiarity with industry standard communication protocols such as Ethernet IP, PROFINET, Modbus TCP, OPC, and BACnet.
10. Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures.
11. Adherence to domestic and international GMP regulations.
12. 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.
13. Able to effectively manage the automation lifecycle of controls components.
14. Familiarity with bioprocessing systems for Drug Substance and Drug Product manufacturing.
Physical Demand Requirements: Manufacturing: Facilities Mechanic:• 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).
#LI-CS1 #LI-Onsite
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Ultragenyx Cambridge, Massachusetts, USA Office
840 Memorial Dr, Cambridge, MA, United States, 02139
Ultragenyx Waltham, Massachusetts, USA Office
303 Wyman St, Waltham, MA, United States, 02451
Ultragenyx Woburn, Massachusetts, USA Office
19 Presidential Way, Woburn, MA, United States, 01801
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