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:
ultrafocused Work together to fearlessly uncover new possibilities
This role will be responsible for supporting Quality Assurance oversight of Facilities Management activities related to internal GMP operations at both our Quality Control Laboratories located in Woburn MA and Gene Therapy Manufacturing Facility (GTMF) located in Bedford MA. This role will work closely with the Facilities Management teams at both locations to ensure planned maintenance unplanned (corrective) maintenance and calibration activities meet CGMP requirements for the documentation trending and escalation of issues. Efforts are focused on ensuring equipment facilities and utilities are maintained in a qualified/validated state for Manufacturing and Testing purposes. Core activities include review and approval or maintenance plans review and approval of unplanned (corrective) maintenance work records and the development or improvement of maintenance work management processes. This role primarily partners with the Facilities & Engineering teams and closely with Validation Manufacturing and Quality Systems.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
- Provide Quality Assurance oversight for Facilities Management to create deploy and manage processes that ensure the facilities utilities and equipment are maintained in a qualified/validated state compliant with applicable health authority requirements and expectations. This is demonstrated through:
- SOPs/Record Management: Approve maintenance procedures work instructions work records and calibration plans directly related to management of facilities utilities and equipment
- Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
- Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment utilities and facilities in area of responsibility during maintenance work
- Training: Ensure all personnel working with Facility Management processes including contractors consultants and temporary employees have the proper qualifications skill sets education and training to perform their job in accordance with applicable procedures and regulations
- Review and approve maintenance records such as planned and unplanned (corrective) work requests. Ensure they are adequately assessed for impact and trends are escalated as appropriate
- Perform periodic BMRAM audit trail reviews
- Write review and/or approve deviations (investigations) CAPA and change controls associated with Facilities Management
- Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management
- Support and maintain Key Quality Performance Indicators for Facility management. Ensure trends are addressed as appropriate
- Participate in inspections and audits for various roles as assigned
Requirements:
- A B.S. degree in Engineering or other Science field such as microbiology chemistry or biochemistry
- Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles
- Direct experience with facility equipment utility and cleaning validation is required. Experience with cell culture and single use systems is also preferred
- Demonstrated experience working with maintenance management systems (e.g. Blue Mountain)
- Direct experience with analytical instrument qualifications computer system validation/computer software assurance and data integrity programs
- Knowledge of relevant FDA and EMA regulations
- Willingness to work in a dynamic and changing corporate environment. Flexible in the face of shifting needs and/or priorities
- Excellent oral and written communication skills with strong technical writing experience is required
- Excellent organizational skills and attention to detail
- Demonstrated analytical approach to problem solving and decision making
- Demonstrated ability to manage multiple priorities for complex projects
- Experience with continuous improvement efforts
- Travel may be required up to 10%. Most travel will be to other Boston-area locations for larger team meetings
Physical Demands/Work Environment/Safety Considerations:
- Stand for extended periods of time with periodic stooping / bending / kneeling
- Able to lift push pull up to 50lbs
- Climb ladders and stairs of various heights
- 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
- Must remove all make-up jewelry and contact lenses while in the manufacturing environment
- Working in temperature-controlled environments (cold rooms)
#LI-CS1 #LI-Onsite
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:
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:
ultrafocused Work together to fearlessly uncover new possibilities
This role will be responsible for supporting Quality Assurance oversight of Facilities Management activities related to internal GMP operations at both our Quality Control Laboratories located in Woburn MA and Gene Therapy Manufacturing Facility (GTMF) located in Bedford MA. This role will work closely with the Facilities Management teams at both locations to ensure planned maintenance unplanned (corrective) maintenance and calibration activities meet CGMP requirements for the documentation trending and escalation of issues. Efforts are focused on ensuring equipment facilities and utilities are maintained in a qualified/validated state for Manufacturing and Testing purposes. Core activities include review and approval or maintenance plans review and approval of unplanned (corrective) maintenance work records and the development or improvement of maintenance work management processes. This role primarily partners with the Facilities & Engineering teams and closely with Validation Manufacturing and Quality Systems.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
- Provide Quality Assurance oversight for Facilities Management to create deploy and manage processes that ensure the facilities utilities and equipment are maintained in a qualified/validated state compliant with applicable health authority requirements and expectations. This is demonstrated through:
- SOPs/Record Management: Approve maintenance procedures work instructions work records and calibration plans directly related to management of facilities utilities and equipment
- Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
- Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment utilities and facilities in area of responsibility during maintenance work
- Training: Ensure all personnel working with Facility Management processes including contractors consultants and temporary employees have the proper qualifications skill sets education and training to perform their job in accordance with applicable procedures and regulations
- Review and approve maintenance records such as planned and unplanned (corrective) work requests. Ensure they are adequately assessed for impact and trends are escalated as appropriate
- Perform periodic BMRAM audit trail reviews
- Write review and/or approve deviations (investigations) CAPA and change controls associated with Facilities Management
- Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management
- Support and maintain Key Quality Performance Indicators for Facility management. Ensure trends are addressed as appropriate
- Participate in inspections and audits for various roles as assigned
Requirements:
- A B.S. degree in Engineering or other Science field such as microbiology chemistry or biochemistry
- Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles
- Direct experience with facility equipment utility and cleaning validation is required. Experience with cell culture and single use systems is also preferred
- Demonstrated experience working with maintenance management systems (e.g. Blue Mountain)
- Direct experience with analytical instrument qualifications computer system validation/computer software assurance and data integrity programs
- Knowledge of relevant FDA and EMA regulations
- Willingness to work in a dynamic and changing corporate environment. Flexible in the face of shifting needs and/or priorities
- Excellent oral and written communication skills with strong technical writing experience is required
- Excellent organizational skills and attention to detail
- Demonstrated analytical approach to problem solving and decision making
- Demonstrated ability to manage multiple priorities for complex projects
- Experience with continuous improvement efforts
- Travel may be required up to 10%. Most travel will be to other Boston-area locations for larger team meetings
Physical Demands/Work Environment/Safety Considerations:
- Stand for extended periods of time with periodic stooping / bending / kneeling
- Able to lift push pull up to 50lbs
- Climb ladders and stairs of various heights
- 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
- Must remove all make-up jewelry and contact lenses while in the manufacturing environment
- Working in temperature-controlled environments (cold rooms)
#LI-CS1 #LI-Onsite
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:
IC
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Job Location:
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
