Validation Specialist (H2R)

The position

Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities from Validation Management. You are working in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim’s global Processes, using agile principles, methods and tools on a daily basis.

You will be qualified to contribute to a cross-functional team and as an H2R Validation Specialist, you will be able to coordinate the activities around change requests, performing impact analysis, reviewing, and approving documents (e.g. System Lifecycle Documents) and ensuring a validated state of the system.

Tasks & responsibilities

• Based on your expertise in Computer System Validation, you ensure that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community.
• Acting as a Validation Management Specialist, you support our daily operation of processes and applications.
• Ensure that our processes and systems are always compliant and in a validated state.
• Furthermore, you manage the execution and documentation of changes and testing activities.
• You are familiar with Agile methods and tools, participating to projects driven with this methodology.
• You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs) to strive for continuous improvement measures.
• Your tools for performing the tasks will by GoTrack, SAP Solution Manager, ITEMS, MyServices, Jira and HP ALM.

About our future employee

You should speak English fluently and have experience in Validation Management, ideally in Computer Systems Validation (CSV).

Additionally, we are looking for:

• Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
• Good knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation.
• Good Knowledge of GxP (Good Practices) regulations within the Pharmaceutical Industry.
• Experience with agile methods (e.g., SCRUM, Kanban) and tools (e.g., JIRA) would be an advantage.
• Good analytical capabilities and problem-solving competence including a proper understanding of prioritization.
• Dedicated team player with good communication skills, and a structured way of working.