Senior Validation Specialist

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 will work 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 MDM Senior Validation Specialist, you will be able to coordinate the activities around change requests, performing impact analysis, reviewing, and approving 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
• You ensure that our processes and systems are always compliant and in a validated state
• Furthermore, you manage the execution and documentation of testing activities
• As part of cross-functional teams, you ensure the implementation and continuous improvement of our standardized processes in global projects
• 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

About our future employee

You should speak English fluently and have around 2 years of 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
• Profound experience in a pharmaceutical or biopharmaceutical production or supporting areas (e.g. quality assurance in production) required
• A strong understanding of pharmaceutical regulations, including those mandated by the FDA, ICH, and European Pharmacopoeia
• Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21 CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation
• Experience in ERP systems (e.g. SAP) is required
• Experience with Veeva Network would be an asset
• 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