Sr. Facilities Engineer
Bedford, NH - USA
Job Summary
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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.
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
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 KPIs.
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.
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).
#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 applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$157800 - $194900 USD
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 .
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.
Required Experience:
Senior IC
About Company
Ultragenyx is focused on developing first-ever approved treatments for rare and ultrarare diseases and moving the rare disease community forward.