Why Join Us
Be a hero for our rare disease patients
At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
The Senior Utilities & Plant 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.
ultrainnovative Tackle rare and dynamic challenges
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.
Responsibilities:
- 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.
- Develops preventative maintenance program and strategies within the CMMS that maximize system/equipment reliability and availability.
- Use reliability-centered maintenance concepts and data to prioritize efforts 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.
- Help establish monitor and drive continuous improvements for facility and utility KPIs.
- 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.
- Provide technical ownership of multiple complex projects/changes at a time.
- Active training and mentoring of junior team members.
- Solutions are expected to incorporate broad experience and input from expert & industry sources.
- Subject matter expert for investigations of any facilities or equipment system deviations or failures and drives the development and implementation of CAPAs.
- Owns and executes change management for facility and utility systems.
- Ensure systems/equipment comply with industry standards and regulations.
- Support the development and revision of governing system/equipment SOPs.
- Identify and drive opportunities for innovation and efficiency in facility systems
- Supports equipment shutdowns and general repairs when necessary.
Requirements:
- Minimum of a Bachelor of Science degree in Chemical Mechanical or related engineering field preferred.
- Minimum of 15 years of experience in a biotech engineering/manufacturing environment preferred.
- 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 including direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site.
- 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.
- 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.
- 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.
- Must remove all make-up jewelry and contact lenses while in the manufacturing environment.
- Working in termperature-controled environments (cold rooms).
#LI-CT1 #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
$142500 - $176100 USD
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
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
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:.
Required Experience:
Senior IC
Why Join UsBe a hero for our rare disease patientsAt Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...
Why Join Us
Be a hero for our rare disease patients
At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
The Senior Utilities & Plant 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.
ultrainnovative Tackle rare and dynamic challenges
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.
Responsibilities:
- 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.
- Develops preventative maintenance program and strategies within the CMMS that maximize system/equipment reliability and availability.
- Use reliability-centered maintenance concepts and data to prioritize efforts 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.
- Help establish monitor and drive continuous improvements for facility and utility KPIs.
- 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.
- Provide technical ownership of multiple complex projects/changes at a time.
- Active training and mentoring of junior team members.
- Solutions are expected to incorporate broad experience and input from expert & industry sources.
- Subject matter expert for investigations of any facilities or equipment system deviations or failures and drives the development and implementation of CAPAs.
- Owns and executes change management for facility and utility systems.
- Ensure systems/equipment comply with industry standards and regulations.
- Support the development and revision of governing system/equipment SOPs.
- Identify and drive opportunities for innovation and efficiency in facility systems
- Supports equipment shutdowns and general repairs when necessary.
Requirements:
- Minimum of a Bachelor of Science degree in Chemical Mechanical or related engineering field preferred.
- Minimum of 15 years of experience in a biotech engineering/manufacturing environment preferred.
- 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 including direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site.
- 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.
- 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.
- 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.
- Must remove all make-up jewelry and contact lenses while in the manufacturing environment.
- Working in termperature-controled environments (cold rooms).
#LI-CT1 #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
$142500 - $176100 USD
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
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
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:.
Required Experience:
Senior IC
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Job Location:
Monthly Salary:
$ 142500 - 176100
Posted on:
6 hours ago
Vacancies:
1 Vacancy
