Ecocareers · 2 months ago
IT Validation Consultant
Raleigh-Durham-Chapel Hill Area, NC
Full-time
Onsite
Senior Level
5+ years expConfidential company is seeking an IT Validation Consultant to develop and execute IT validation activities. The role involves ensuring compliance with internal SOPs and external regulations, as well as supporting IT system lifecycle activities.
Staffing & Recruiting
Responsibilities
Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls
Author 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
Qualification
Required
Bachelor's degree in engineering, Computer Science, or related technical field
Minimum 5 years of experience in computerised system validation within pharmaceutical or life sciences projects
Strong knowledge of GxP documentation requirements and regulatory audits
Ability to create validation documentation independently
Preferred
Familiarity with pharmaceutical manufacturing processes (Fill/Finish)
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase