Job Title: Test Engineer

Job Location: Macclesfield (2-3 days per week onsite)

Job type: 12 months contract with possible extension (outside IR 35)

Note- Pharma industry experience with Veeva Vault / GxP regulatory experience is mandatory to have

Background / Context

Client is driving a major change program to replace our Regulatory Information Management [RIM] platform. ANGEL, our current RIM platform, has served us well for nearly a decade. It represented the best technology that was available at the time of its development, but because of the lack of an end-to-end solution in the marketplace, ANGEL today consists of fragmented systems with many custom-built applications to fill gaps in functionality. This has led to a complex environment that requires a lot of manual work, handoffs and systems that don't talk to one another.

The ANGEL platform today consists of these primary elements:

• Document Management: Electronic Document Management System (EDMS) for regulatory information, utilizing Cara from Generis
• Tracking: License and registration management and tracking, utilizing Register from ArisGlobal, with several ancillary tools filling in capability gaps
• Publishing: Submission publishing and dispatch to health authorities, utilizing Regulatory Solutions Suite [RSS] from DXC, along with ancillary tools to support submission viewing and capability gaps

We are engaging Veeva with the ultimate goal of an end-to-end system called Enterprise Regulatory Vault [ERV] that handles the complete regulatory lifecycle from submission planning, to content authoring, to publishing and submission to health authorities, and the management and tracking of product registrations.

Role summary

The test engineer will work within an agile team to create and execute test scripts to validate client's Veeva Regulatory Information Management system against user stories (aka requirements).

Tasks

• Author, maintain and execute test scripts to validate ERV using Jira X-Ray
• Conduct user acceptance testing (UAT) and Business Verification testing (BVT)
• Review and update existing scripts to maintain currency with the evolving platform
• Document and report test results for functional areas of responsibility
• Develop expertise in ERV system and share with others in business and program
• Support go-live activities via through testing, resulting in successful product releases
• Provide analysis and recommendations against test executions and test results
• Raise bugs/defects resulting from testing; follow-up for resolution
• Support the ERV team by focusing on solving problems and implementing solutions
• Communicate daily with ERV testing teams to coordinate tests
• Provide information for status reports

Essential for the role

• Experience authoring and executing UAT (user acceptance test) scripts
• Experience interpreting business user stories (aka requirements) and translating to test scripts
• Experience with system development lifecycle of validated systems / platforms within a regulated environment
• Experience in agile system development and working within a global team
• Fluent in written and verbal English

Desirable for the role

• Experience working with GxP regulated systems within the biopharmaceutical industry
• Experience with Veeva Vault applications, preferably the Veeva Regulatory Suite
• Knowledge of Regulatory Information Management systems and practices
• Professional qualification in software testing, e.g. ISTQB/ISEB Foundation certification

Ability to build relationships across, cultures, functions and disciplines to deliver a quality service

GCS Computer Recruitment Services is acting as an Employment Business in relation to this vacancy.