Senior System Integration Engineer - GMP Environment

Job Overview

Joining a world leader in delivering digital transformation solutions to Life Sciences, you will be working with multiple vendors, global and local teams to build and configure software into an integrated system.

You will be part of a team responsible for implementing IT reporting solutions that will be used during the batch release process.

You will be involved in the whole product life cycle, from requirements through design, testing and delivery of the system into production.

Responsibilities:

  • Liaise with the business and existing IT resources to gather and document the business requirements
  • Liaise with the vendors to configure, implement and integrate the software components to build the solutions
  • Assist the Project Manager in identifying and mitigating technical risks
  • Support the Project Manager in the preparation of timescales and adherence to schedule
  • Prepare Project validation deliverables i.e. Validation Plan, Requirements, Design, Test Plan, Test documentation, Validation Report
  • Plan the testing of the individual system components and the integrated testing of the overall system.
  • Write and/or execute test scripts, prepare defect reports and Test Summary Report
  • Coordinate the testing of the overall solution with business users
  • Resolve technical issues arising during the project/product lifecycle
  • Ensure compliance with Corporate Quality Standards and Practices

Requirements:

  • Experience of application installation and formalised approach to Change Control
  • Experience in product lifecycles from gathering customers requirements through design to system delivery and acceptance.
  • Experience writing life-cycle documentation validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting.
  • Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered at or above expectations.
  • Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
  • Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
  • Experience of working in a GMP environment.
  • Database, SQL, ETL, API and data analytical skills
  • Knowledge of IT reporting/dashboard tools is also an advantage

Are you the person we are looking for? We are shortlisting now so please APPLY via the 'Apply' button below

Not Ready to Apply??? Feel free to reach out to me James Roche for a confidential discussion on 087 6029427 or email me at

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