Validation Engineer

Job Title

Responsibilities:

• Support of creating and maintaining GxP (GMP, GCP, GLP) quality and perform GxP and 21 CFR part 11 assessments and develop a validation plan.
• Develop functional risk strategy and perform functional risk assessment.
• Review user business process documents and user requirements specification.
• Review functional, technical and configuration design documents.
• Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
• Draft the OQ & PQ test scripts for the GxP requirements and E2E GxP test scenarios.
• Support overall protocol executions, log and track defects.
• Review the executed test protocols for the proper documentation of test results and evidence.
• Review the defects for proper documentation per the checklist.
• Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.
• Prepare and approve qualification summary report.
• Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
• Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI), and training materials.

Requirements:

• Excellent communication (oral and written) and attention to detail.
• Experience in CSV/Validation in Pharmaceuticals or Medical Device domain with experience in managing large global SAP validation projects.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
• Excellent knowledge of computer system validation and GAMP -5 standards.