Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Facilities Engineer candidate will partner closely with GMP Facilities and be responsible for providing engineering support for GMP and non GMP utility systems (including WFI, HVAC, chilled water, electrical systems, condensate systems, gases, etc.) at Ultragenyx Gene Therapy GMP Manufacturing and Laboratory facilities located in Bedford, MA and Woburn, MA. The candidate will be the primary engineering resource for operational support and process improvements related to the facility and utility systems within the sites.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

1. Technical and Quality ownership of facility and utility systems including on site troubleshooting and investigations; provides on-call operational support in the event of any equipment issues.

2. Independently solves complex problems within area of expertise without supervision. Exercises independent judgment to determine and recommend appropriate actions on behalf of engineering and represents engineering programs to external regulatory agencies

3. Improves preventative maintenance program and strategies within the CMMS that maximize system/equipment reliability and availability.

4. Use reliability-centered maintenance concepts and data to prioritize eAorts and system improvements/optimization. Monitor and trend repeat equipment failures and perform root-cause analysis to identify cause and recommend and implement corrective actions, as necessary.

5. Help establish, monitor, and drive continuous improvements for facility and utility KPI's.

6. Independently owns tasks and deliverables for projects and will be main Engineering point of contact for facility and utility projects from design through commissioning/validation.

7. Provide technical ownership of multiple complex projects/changes at a time.

8. Active training and mentoring of junior team members.

9. Solutions are expected to incorporate broad experience and input from expert & industry sources.

10. Subject matter expert for investigations of any facilities or equipment system deviations or failures and drives the development and implementation of CAPAs.

11. Owns and executes change management for facility and utility systems.

12. Ensure systems/equipment comply with industry standards and regulations.

13. Support the development and revision of governing system/equipment SOPs.

14. Identify and drive opportunities for innovation and eAiciency in facility systems

15. Supports equipment shutdowns and general repairs when necessary.

Requirements:

1. Minimum of a Bachelor of Science degree in Chemical, Mechanical, or related engineering field preferred.

2. Minimum of 8-10 years of experience in technical functions including Utilities/Plant Engineering, or related functions in a cGMP manufacturing environment.

3. Demonstrated leadership skills in executing projects within an FDA/EMA regulated environment, including direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site.

4. Experience and knowledge related to reviewing and approving equipment submittals, functional and configuration specifications, maintenance and calibration, equipment installation, and specifications with facilities, equipment, and utilities related to drug substance and/or drug product manufacturing.

5. Extensive knowledge of industry standards for cGMP engineering design, commissioning, validation, and operation of bioprocessing equipment and utility systems related to drug substance and/or drug product manufacturing.

6. Demonstrated experience working with Computerized Maintenance Management Systems (e.g., Blue Mountain RAM, Maximo, EAM, etc).

7. Proven record with troubleshooting, problem solving, and investigational skills.

8. Experience with quality systems including change controls, CAPAs, deviations, etc.

9. Strong interpersonal and communications skills with ability to present to regulatory authorities, key stakeholders, and senior management eAectively.

10. Willingness to work in a dynamic and changing corporate environment. Flexible in the face of shifting needs and/or priorities.

Physical Demand Requirements

• Stand for extended periods of time with 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.

• Working in temperature-controlled environments (cold rooms).

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