IT Validation Consultant

Chapel Hill, NC, US • Posted 60+ days ago • Updated 4 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Test Plans
Incident Management
Risk Assessment
Regulatory Compliance
Security Controls
Computer Science
Life Sciences
GxP
Auditing
Documentation
Pharmaceutics
Manufacturing

Summary

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).

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 63252f8d667c01190f3bef52975c6010
Posted 30+ days ago

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IT Validation Consultant

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Job Details

Skills

Summary

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