Full-time · NC, United States of America
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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
WE STRONGLY ENCOURAGE OUR VETERAN COMMUNITY TO APPLY
The Staff/Sr Process Engineer - Compliance will plan, develop, improve, organize, and implement the Equipment lifecycle program according to multiple regulatory bodies. They will also help improve our quality maturity in the engineering organization. This function will be responsible to reduce quality defects in our business and processes and provide practical GMP guidance and mentorship to our teams. The engineer will own and execute root-cause investigations, implement action plans for nonconformance's, internal/external audits and other compliance related matters. GRAIL’s processes are scaling fast and require a dynamic and detail oriented engineer to help deliver our revolutionary test to as many people as possible.
Expected schedule is on-site Monday to Friday. This position may need to support weekends and holidays. Alternative locations and work arrangements could be considered for the right individual.
Responsibilities;
Preferred qualifications;
5+ years of related experience with a BS/BA or higher degree in Engineering or Life Sciences or equivalent
Experience executing within a computerized maintenance/calibration management system, product lifecycle managements systems, and quality management systems
Experience working in a clinical laboratory regulated environment
Knowledge of lean tools and root cause analysis methodologies
Strong background in GMP manufacturing
Project management skills
Ability to work in a matrix organization
High emotional intelligence with proven ability to set a course and bring his/her peers forward with them.
Excellent communication skills to work as a leader, provide internal customer support, and influence other departments and individuals
Excellent time management skills to support a fast paced working environment
Strong leadership skills with demonstrated ability to effectively work across teams and functions
Highly Preferred:
Graduate degree in an engineering or scientific discipline
Veeva experience
Experience with Laboratory Information Management Systems (LIMS) and Manufacturing Management Systems (MES)
Ability to travel up to 15% of the time
Open roles at GRAIL