Join Ultragenyx as a Senior Utilities Plant Engineer II and contribute to leading the future of rare disease medicine. Partner with GMP Facilities to provide engineering support for GMP and non-GMP utility systems. The role requires a minimum of 15 years of experience in a biotech engineering/manufacturing environment and a Bachelor of Science degree in Chemical, Mechanical, or related engineering field.
Requirements
- Minimum of a Bachelor of Science degree in Chemical, Mechanical, or related engineering field
- Minimum of 15 years of experience in a biotech engineering/manufacturing environment
- Minimum of 15 years of experience in technical functions including Utilities/Plant Engineering, or related functions
- Demonstrated leadership skills in executing projects within an FDA/EMA regulated environment
- Experience and knowledge related to reviewing and approving equipment submittals, functional and configuration specifications, maintenance and calibration, equipment installation, and specifications
- 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
- Demonstrated experience working with Computerized Maintenance Management Systems (e.g., Blue Mountain RAM, Maximo, EAM, etc)
- Proven record with troubleshooting, problem solving, and investigational skills
- Experience with quality systems including change controls, CAPAs, deviations, etc
- Strong interpersonal and communications skills with ability to present to regulatory authorities, key stakeholders, and senior management effectively
Benefits
- 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
