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Senior Validation Engineer
Updated on 9/23/2022
Locations
Raleigh, NC, USA • Durham, NC, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Analysis
Management
R
Research
Writing
Requirements
  • A Bachelor's Degree in an Engineering or Life Sciences Discipline
  • A minimum of five (5) years of delivering qualified equipment into a manufacturing or production environment
  • Significant experience translating user needs and design inputs into instrument qualification protocols
  • Proficient knowledge of FDA Regulations/Guidance, Good Manufacturing Practices (ISO 13485), and Medical Device validation/qualification requirements
  • Demonstrated statistical analysis skills in order to collate data for and assign values to parameter specifications Ability to manage multiple activities and constantly change priorities
  • Familiarity with lab operations, processes, and a variety of laboratory instruments within Biological, Chemical, Environmental Monitoring, or similar areas
  • Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
  • Experience transferring concepts and documentation from R&D into operational environments
  • Excellent communication skills, oral and written, and attention to detail Strong critical thinking and problem-solving skills
  • A Master's Degree/PhD in an Engineering or Life Sciences Discipline
  • A minimum of three (3) years of experience delivering qualified equipment into a manufacturing or production environment
  • Familiarity with LDT requirements for equipment and their differences from cGMP
  • Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11
Responsibilities
  • Serve as validation lead for laboratory instruments on a highly automated, high throughput clinical assay
  • Translate User Needs, System Requirements, and assay tolerances into technical specifications
  • Partner with the Clinical Lab Managers, Quality System Administrators, and Equipment and Process Engineers to qualify new instruments at the site
  • Author and Maintain the Equipment Qualification Master Plan to define validation strategy for laboratory equipment used within a regulated diagnostic test
  • Initiate and lead risk assessments, gap analysis, and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Control laboratories
  • Author cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs
  • Ensure lab instrument's adherence to regulatory guidelines, as necessary, to cGMP, FDA 21 CFR Part 11, CLIA and CAP
  • Author protocols to challenge the main aspects of these requirements during validation to demonstrate adherence
  • For systems found unable to fully comply, formulate workarounds/strategies with core stakeholders to mitigate the gaps
  • Assist the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans
  • Complete periodic reviews of laboratory instruments (production and R&D) and associated instrument control software with focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument. Identify and consult with Operations Team stakeholders to integrate qualification procedures into the framework for existing work streams
  • Analyze data from multiple sources and help the team balance operator efficiency, cost of goods, and system uptime while maintaining a safe and compliant work environment
  • Write and maintain user manuals, process flow charts, SOP's, and work instructions around your developed methods
  • Review validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed
  • May supervise and/or mentor junior level engineers
GRAIL

501-1,000 employees

Designs cancer screening tests
Company mission
GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
Benefits
  • Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
  • Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
  • Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
  • Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
Company Values
  • Grit - We are determined and resilient because patients are counting on us.
  • Respect - We value diversity and challenge each other respectfully.
  • Accountability - We own our decisions and keep our commitments.
  • Integrity - We adhere to our principles of humility, transparency, and rigor.
  • Leadership - We make each other better by making leadership everyone’s responsibility