Oxford Biomedica

Validation Engineer III

Oxford Biomedica

full-time

Posted on:

Location Type: Office

Location: Durham • North Carolina • United States

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About the role

  • Write, execute, summarize and lead validation activities for analytical instruments, computer systems, equipment, utilities, and facilities
  • Development of validation plans and validation plan summary reports
  • Develop, review, and provide guidance on internal validation documents
  • Develop, support, and assess CAPAs, change controls, deviations, investigations and risk management as they pertain to validation
  • Provide technical input to strategy/philosophy for validation activities
  • Represent validation during tech transfer activities
  • Front facing during agency inspections and client audits representing the validation function
  • Lead and manage complex validation and technical projects
  • Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support

Requirements

  • Minimum of bachelor’s degree in science, engineering or related discipline
  • 5+ years of experience in the execution of validation studies in a regulated manufacturing environment
  • Thorough knowledge and understanding of FDA and international health authority expectations
  • Experience in authoring and review/approval of CQV documentation including validation plans, protocols, reports, trace matrices and SOPs
  • This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
Benefits
  • Competitive total reward packages
  • Wellbeing programs that support your mental and physical health
  • Career development opportunities to help you grow and thrive
  • Supportive, inclusive, and collaborative culture
  • State-of-the-art labs and manufacturing facilities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
validation activitiesvalidation plansCAPAschange controlsdeviationsrisk managementCQV documentationSOPstroubleshootingtechnical project management
Soft Skills
leadershipcommunicationtechnical supportproblem-solvingclient representation
Certifications
bachelor’s degree in sciencebachelor’s degree in engineering