Computer System Validation Engineer

Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes

Follow SOPs and industry best practices

Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.

Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system

Review validation deliverables for projects which are contracted to third party suppliers

Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

Assist in planning, implementing, and documenting user acceptance testing

• Review computerized systems validation documents such as:

• Requirements Specification

• Design Specification

• CSV Risk Assessment

• Test Plans

• Test Summary Reports

• Data Migration Plan

• Pre/Post Executed Test Scripts

• Traceability Matrix

• Release to Production Statements

Direct and review testing

Provide guidance on quality issues that affect the integrity of the data or the system

Obtain and respond to QA review

Participate in establishing standard quality and validation practices

Independently assess compliance practices and recommend corrective actions

Approve validated computer system related change requests

Monitor regulatory and inspection trends and advise the business on suitable action

Ability to create documents to an existing document standard.

Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.