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Job: Validation Engineer, Foundation Medicine, Morrisville, NC
Morrisville, NC 27560 United States
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's initial clinical product, FoundationOne™, is a fully informative genomic profile to identify a patient's individual molecular alterations and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.
Reporting to the Manger of Quality Assurance, the mission of the Validation Engineer is to provide documented evidence that the laboratory equipment, systems, and processes involved in in vitro diagnostic testing, perform in a qualified and reproducible manner and comply with the diverse regulatory requirements necessary for product release on a global scale. The deliverables of the Validation Engineer include validation plans, approved Validation protocols and Final Reports. These documents are made available to the world-wide regulatory agencies via inclusion within regulatory filings, and during audits and inspections of the RTP facility. This is a unique opportunity to be the first validation engineer dedicated to the RTP facility, you will still have the expertise and guidance from our group in Cambridge but the right candidate should be excited about working independently and having a sense of ownership over that site.
• Perform validation in a GMP clinical laboratory facility managing multiple validation projects and providing technical assistance to less experienced technicians/engineers.
• Assist Manager/ Director in establishing and generating Validation department procedures.
• Develop Validation plans for medium to large size validation projects.
• Write, review and approve qualification/validation protocols and reports as well as execute protocols. Resolve protocol discrepancies and deviations.
• Knowledge of risk based validation approaches that meet current regulatory requirements, internal standards and industry practices.
• Responsible for peer review of validation reports and present the validation approach and study results to peers and managers.
• Present and defend validation studies during regulatory inspections and internal audits.
• Generate, review and approve deviations, CAPAs, perform/lead investigations and root cause analysis.
• Perform change control assessment.
• Perform SOP revision, review and approval.
• Complete all internal and external training.
• Create/compile validation documentation necessary to meet FDA and international requirements.
• Bachelor's degree in engineering/science and 4+ years of validation experience or Master's degree in engineering/science and 2+ years of validation experience.
• Familiarity with applicable US and worldwide regulatory requirements.
• Ability to read/interpret engineering drawings and design documents.
• Management of small to medium size projects.
• Excellent technical writing and verbal communication skills.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
• Knowledge of Validation Lifecycle Approach. Solid understanding of Quality Assurance life cycle, methodologies and best practices.
• Ability to understand interdependencies and relationships among software and system components.
• In-Vitro Diagnostics / Assay development experience.
• Experience working within a Clinical Lab Systems setting.
• Driven. You will be focused on the achievement of major alliance goals.
• Solutions focused. Willing to bring creative problem-solving skills to challenges along the way.
• Scientifically-oriented. You will enjoy learning and being involved in the content of our collaboration activities, and able to converse fluidly with internal and external team members on project goals and activities.
• Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise.
• Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent.
• Ability to communicate clearly and concisely with all stakeholders.
• Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the collaborations.
Apply Here: http://www.Click2Apply.net/zx2cppvfd725ybrn
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