Process Engineer II, GMP Manufacturing - Gene Therapy

Company: Ultragenyx Pharmaceutical
Location: Woburn
Posted on: February 25, 2021

Job Description:

Process Engineer II, GMP Manufacturing - Gene Therapy Woburn, MA - 150 P / Ultragenyx - Gene Therapy - Engineering / 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 do.--To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't 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 work. -- Ultimately, 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 and -- personally, come join our team.-- During the COVID-19 Outbreak,--we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach--will include--video discussions, interviews, and--onboarding. Position Summary ultrainnovative - Tackle rare and dynamic challenges The Process Engineer candidate will partner closely with the Engineering & Facilities leadership team and will be responsible for process engineering support of GMP manufacturing systems at existing Ultragenyx Gene Therapy GMP facilities as well as the design for a new state of the art Gene Therapy Manufacturing facility in Massachusetts. The candidate will be responsible for generating system specifications, reviewing design submittals, selection of systems, and leading implementation, start up, and commissioning of process systems within the new GMP gene therapy manufacturing site. Once the manufacturing site is in operation, 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. The candidate will be expected to build cross-functional relationships within UGT and external consultants and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of new process equipment for the cGMP manufacturing facility. 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 management on engineering challenges and objectives and be expected to implement innovative and robust solutions. The candidate will provide input in the development of Engineering programs, standards, and processes for the site. Experience with development of a single use program and support of a single use facility is strongly desired. The candidate will collaborate with key cross-functional stakeholders to plan and manage operational aspects of major capital investments along with the Ultragenyx Global Engineering team and will be responsible to ensure compliance with Ultragenyx SOP's, safe work practices, training program, and cGMP regulations. The candidate will report to the Associate Director of Engineering for UGT. Responsibilities

• Support design, selection, implementation, start up, and C&Q of upstream, downstream and fill finish systems for a new GMP gene therapy manufacturing facility.
• Ensure proper protocols are followed to maintain compliance with equipment, facility, automation and asset management infrastructure. Reviews facility and equipment technical documentation in support of regulatory submissions.
• Executes engineering testing and protocols.
• Technical ownership of process equipment systems 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.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards. Requirements
  • Minimum of a Bachelor of Science degree. Chemical, Mechanical, Electrical Engineering or related engineering field preferred.
  • Minimum of 3 years of experience in the biotech engineering/manufacturing environment.
  • Minimum of 3 years of experience in a technical function including Process Engineering, Utilities/Plant Engineering, Automation/I&C Engineering, Validation or related functions.
  • Demonstrated experience with bioprocess system design and bioprocessing methods.
  • Familiarity with new product introduction and technology transfer.
  • Expertise with single use systems, materials, and programs is strongly desired.
  • Familiarity with 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. #LI-CZ1 Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact--Talent Acquisition--by calling:--(415) 483-8800--or by--emailing--us at--talentacquisition@ultragenyx.com . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. 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 .

Keywords: Ultragenyx Pharmaceutical, Boston , Process Engineer II, GMP Manufacturing - Gene Therapy, Healthcare , Woburn, Massachusetts