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IT Validation Consultant

Katalyst Healthcares and Life Sciences

Cary, NC

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Change Control, Code of Federal Regulations, Computer Science, Corrective Action, Documentation, Drug Manufacturing, GxP, Incident Management, Information Technology & Information Systems, Information Technology Consulting, Maintain Compliance, Manufacturing/Industrial Processes, Risk Analysis, Security Compliance, Standard Operating Procedures (SOP), System Lifecycle, System Validation, Technical Support, Test Plan/Schedule, Validation Documentation, Validation Plan, Validation Testing
LOCATION
Cary, NC
POSTED
6 days ago
Responsibilities:
  • Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls.
  • uthor validation plans, verification reports, and decommissioning documentation.
  • Ensure compliance with internal SOPs and external regulations (21 CFR Part 11, GxP, etc).
  • Participate in investigations of validation deviations and implement corrective actions.
  • Support IT system lifecycle activities, including maintenance, incident management, and risk assessments.
  • Conduct system reviews to ensure compliance and security controls are in place.
Requirements:
  • Bachelor's degree in engineering, Computer Science, or related technical field (preferred).
  • Minimum 5 years of experience in computerised system validation within pharmaceutical or life sciences projects.
  • Strong knowledge of GxP documentation requirements and regulatory audits.
  • bility to create validation documentation independently.
  • Familiarity with pharmaceutical manufacturing processes (Fill/Finish preferred).

About the Company

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Katalyst Healthcares and Life Sciences