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Software Validation Engineer
A company is looking for a Software Validation Engineer (Manufacturing). Key Responsibilities Standardize and streamline validation processes to ensure compliant software delivery Coordinate with functional groups to understand, document, and validate software requirements Lead and support continuous improvement initiatives within the organization Required Qualifications 5+ years of experience in pharmaceutical, medical device, or biotechnology industry software quality engineering and assurance Background in 21 CFR Part 11-compliant software validations Knowledge of industry regulations and standards (GAMP, GMPs, ISO 9001, ISO 13485, 21 CFR Part 820) Experience with software used for data collection, storage, analysis, and project management Proficiency in Microsoft Office applications
A company is looking for a Software Validation Engineer (Manufacturing).
Key Responsibilities
Standardize and streamline validation processes to ensure compliant software delivery
Coordinate with functional groups to understand, document, and validate software requirements
Lead and support continuous improvement initiatives within the organization
Required Qualifications
5+ years of experience in pharmaceutical, medical device, or biotechnology industry software quality engineering and assurance
Background in 21 CFR Part 11-compliant software validations
Knowledge of industry regulations and standards (GAMP, GMPs, ISO 9001, ISO 13485, 21 CFR Part 820)
Experience with software used for data collection, storage, analysis, and project management
Proficiency in Microsoft Office applications