Validation Specialist (Produce to Engineering & EHS)
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 a Validation Specialist in the area of Engineering & EHS 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 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 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.
About our future employee
You should speak English fluently and have min. 2 years of experience in the CSV area.
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.
- 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 the following domains required:
- Plant Maintenance (e.g. SAP PM) and calibration processes
- EHS (e.g. SAP solutions) processes
- Good Knowledge of GxP (Good Practices) regulations within the Pharmaceutical Industry would be an advantage
- 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.