Business and System Integration Engineer
AutoStream Global are partnering up with global leading pharmaceutical, medical device and biotechnology companies that are looking for Business and System Integration Engineers. The companies are looking to place the individuals in sites situated in Ireland and mainland Europe.
- 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 solution
- 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
- Minimum 2-3 years' experience implementing and supporting IT applications
- Background in software development and systems analysis/configuration
- Experience of application installation and formalised approach to Change Control
- Experience in product lifecycles from gathering of customers requirement through design to system delivery and acceptance.
- Experience of 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.
- Self-motivated, ability to work independently
- 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 also an advantage