Requirements:

• Education: Minimum of a Bachelor of Science degree in Chemical, Mechanical, or related engineering field preferred.
• Experience: Minimum of 8-10 years of experience in technical functions including Utilities/Plant Engineering, or related functions in a cGMP manufacturing environment.
• Leadership: 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.
• Review and Approval: 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.
• Industry Standards: 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.
• CMMS Experience: Demonstrated experience working with Computerized Maintenance Management Systems (e.g., Blue Mountain RAM, Maximo, EAM, etc).
• Troubleshooting: Proven record with troubleshooting, problem solving, and investigational skills.
• Quality Systems: Experience with quality systems including change controls, CAPAs, deviations, etc.
• Communication Skills: Strong interpersonal and communication skills with the ability to present to regulatory authorities, key stakeholders, and senior management effectively.
• Flexibility: 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 the use of a respirator; medical clearance will be required in advance.
• Working in temperature-controlled environments (cold rooms).

#LI-CS1 #LI-Onsite

Compensation:

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 the applicant's geographic location.

• Salary Range: $157,800—$194,900 USD

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Benefits:

Full-Time employees across the globe enjoy a range of benefits, including, but not limited to:

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long-term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans

Benefits vary by region and country

Equal Opportunity Employer:

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 talentacquisition@ultragenyx.com.

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Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

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.