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Senior Quality Engineer - Validation

Raleigh-Durham, NC - Quality Full-Time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

The Senior Quality Engineer (Validation) is responsible for quality oversight of validation activities, particularly process and method validation at the Orion Site. In this position, you will ensure compliance with applicable regulations in support of GxP compliant programs, and cGMP manufacturing, both internally and with external partners. You will drive critical processes, initiatives, and strategy for the site.
You Will:
  • Provide oversight and ensure that GMP standards and regulatory requirements related to Validation are adhered to in projects both internally and with external partners.
  • Develop, maintain, and execute the site’s Validation Master Plan.
  • Provide oversight of validation and qualification activities for internal equipment, analytical instruments, and computer systems.
  • Participate in or moderate cross-functional risk assessments to define the scope of validation activities especially in response to changes.
  • Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures.
  • Act as Subject Matter Expert in the assessment and execution of deviations during validation activities.
  • Assist the department in developing programs and procedures to meet current industry standards, internal and external regulatory requirements.
  • Lead and/or participate in internal audits as needed to support GxP activities.
  •  Support external regulatory, customer and third-party audits.
  • Manage projects in a cross functional environment that drives quality compliance and continuous improvement.
  • Mentor personnel to support development and growth of staff.

  • Your Background Should Include
  • Bachelor’s Degree in Biomedical Science, Engineering or related field in Technical Discipline.
  • >10 years of Quality experience in the life sciences industry, in a high-complexity CLIA or FDA regulated environment.
  • >7 years in Validation
  • Expert knowledge of all validation areas: facilities / utilities, equipment, process, and analytical methods.
  • Strong knowledge of CLIA/CAP, ISO and/or FDA regulations
  • Strong team player with demonstrated track record of success in a cross-functional team environment.
  • Ability to influence and be the voice of Quality when dealing with multiple groups in the organization.
  • Must have excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
  • Manages change well and adopts a continuous improvement orientation to the role.
  • Excellent communication and interpersonal skills.

  • We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.