Ultragenyx is seeking a Process Engineer II/III to support its gene therapy manufacturing facility in Bedford, MA. The Process Engineer II/III candidate will partner closely with the Engineering & Facilities leadership team and will be responsible for process engineering support of GMP manufacturing systems at the Gene Therapy Manufacturing facility and QC lab in Massachusetts.
The candidate will be a primary process engineering contact for operational support related to drug substance upstream, drug substance downstream and drug product manufacturing systems including base utilities (i.e. WFI, HVAC, process gases), and autoclaves/glasswashers. The candidate will also be the liaison between clients in Manufacturing and vendor resources in the design, specification, and commissioning of new process equipment for the cGMP manufacturing facility.
The candidate will collaborate with key cross-functional stakeholders to plan and manage operational aspects and will be responsible to ensure compliance with Ultragenyx SOP’s, safe work practices, training program, and cGMP regulations. All system improvements will be made in close collaboration with Manufacturing, Facilities, Manufacturing Sciences, Validation, Quality Assurance, and possibly Regulatory. The candidate will serve as a consultant to senior team members and management on major engineering challenges and objectives and be expected to develop and implement innovative and robust solutions.
The candidate will also have involvement in the development of Engineering programs, standards, and processes for the site. Experience with support of a single use facility is strongly desired.
The candidate will report to the Associate Director of Engineering for Ultragenyx.
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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 ownership of upstream/downstream process equipment and provide on-call operational support in the event of any equipment issues
- Ensure proper protocols are followed to maintain compliance with equipment, facility, automation, and asset management infrastructure. Review of facility and equipment technical documentation in support of regulatory submissions
- Assumes technical ownership of multiple projects/changes at a time that are complex
- Develop project plan without supervision
- Training and mentoring of more junior team members
- Growth includes determining novel and innovative solutions to complex problems
- Technical ownership of process support & utility equipment and provides on-call operational support in the event of any equipment issues
- Supports investigations of any equipment system deviations or failures and drives the development and implementation of CAPAs
- Supports change management for manufacturing systems and works with senior team members to prioritize work
- Minimum of a Bachelor of Science degree. Chemical Engineering, Biochemical Engineering or related engineering field preferred
- Minimum of 2-4 years of experience in the biotech engineering/manufacturing environment
- Minimum of 2-4 years of experience in a technical function including Process Engineering, Utilities/Plant Engineering, Automation/I&C Engineering, Validation or related functions
- Experience in new product introduction and technology transfer preferred
- Experience with single use systems, materials, and programs is strongly desired
- Extensive knowledge of industry standards for cGMP engineering design, commissioning, validation, and operation of bioprocessing equipment
- Proven track record with troubleshooting, problem solving, and investigational skills
- Experience with quality systems including change controls, CAPAs, deviations, etc.
- Strong interpersonal and communications skills and ability to present to clients and senior management effectively
- Travel: < 10%
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 contract lenses while in the manufacturing environment
- Working in temperature controlled environments (cold rooms)
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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 applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
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 [email protected].
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.
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Ultragenyx Cambridge, Massachusetts, USA Office
840 Memorial Dr, Cambridge, MA, United States, 02139
Ultragenyx Waltham, Massachusetts, USA Office
303 Wyman St, Waltham, MA, United States, 02451
Ultragenyx Woburn, Massachusetts, USA Office
19 Presidential Way, Woburn, MA, United States, 01801
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