Validation Specialist (Produce to Engineering & EHS)

Join to apply for the Validation Specialist (Produce to Engineering & EHS) role at Boehringer Ingelheim

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.

As a Validation Specialist in the area of Engineering & EHS, you will coordinate 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, ensure that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community.
• Act as a Validation Specialist, supporting our daily operation of processes and applications.
• Ensure that our processes and systems are always compliant and in a validated state.
• Manage the execution and documentation of testing activities.
• Participate in projects driven with Agile methodology.
• Be measured against KPIs/SLAs to strive for continuous improvement.

Qualifications

You should speak English fluently and have a minimum of 2 years of experience in the CSV area.

• 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: Plant Maintenance (e.g. SAP PM) and calibration processes; EHS (e.g. SAP solutions) processes.
• Good knowledge of GxP 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 proper understanding of prioritization.
• Dedicated team player with good communication skills, and a structured way of working.

About the Company

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after. By being part of a team that is constantly innovating, youll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com