Staff Process Engineer - Compliance # 2411
1525 O'Brien Drive
Menlo Park, CA 94025
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 non-conformances, 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.
Anticipates and resolves conflict situations in a win - win outcome
Assure compliance with SOX, CLIA/CAP, FDA 21 CFR part 820, ISO 13485, IVDR requirements
Create and update work instructions, guidelines, verifications, and standard operating procedures (SOP)
Develop roadmaps and lead initiatives to ensure long term compliance sustainabilityLeads CAPAs and associated quality investigations
Participate, be a role model, and adhere to GRAIL’s policies and guidelines
Provide training, support in the creation of new training, and transfer knowledge
Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process
Supports audit readiness and on-site auditsWork closely with
Quality and regulatory to implement and follow the required policies and procedures for the lifecycle of equipments
Your qualifications and background will include:
8+ years of related experience with a BS/BA or higher degree in Engineering or Life Sciences
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 environmentExperience 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 leadership skills with demonstrated ability to effectively work across teams and functions
Strong background in GMP manufacturing
Graduate degree in an engineering or scientific discipline
Experience with Laboratory Information Management Systems (LIMS) and Manufacturing Management Systems (MES)
Project management skills
Physical Demands/Working Environment:
Travel up to 15% of the time
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine and “Up to Date” with any recommended booster. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered; "Up to Date" means having timely received any COVID-19 vaccine booster(s) in accordance with CDC guidelines. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.
How to Apply
About Our Organization
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.