Our client is a leading global biopharmaceutical company that has been inventing for life for more than a century. Bringing forward medicines and vaccines for many of the world's most challenging diseases.
Within the company a global program was started to protect the company against cyber treats and natural disasters. This Enterprise Resilience Modernization and Data Integrity (ERMD) program exists to ensure the company is better protected and becomes more resilient when something happens in this area.
General requirements are defined for systems on Security, Modernization and Data Integrity. A system inventory shows that a large amount of automation systems need modifications to comply with the ERMD requirements.
A Taskforce identified several projects: 25% of the projects require equipment replacements or upgrades and 75% are automation driven. 10 project teams execute the automation driven projects. They determine the project scope to upgrade or replace the automation. After approval by a central board a strict schedule will be followed to document, upgrade or replace and test the automation to meet the final integration date.
- You write the Qualification Plan, Requirement Specifications, User Acceptance test protocol, and Qualification Report;
- You are responsible for compliance with the ERMD requirements and the validated state;
- Interpretation of the compliance will be agreed with the Quality Officer;
- You report progress deviations to the project leaders;
- Proactive and result oriented team player;
- Familiar with process Automation;
- More than 5 year experience with validation in Life Science / pharma;