(Senior) Produce to Engineering & EHS Process 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 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 P2E 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 process and system changes (demands) are managed according to our validation rules, as well as documenting and analyzing proposed solutions, in close cooperation with experts in our GBS community.
• You support the execution of business tasks required to deploy approved demands, under the coordination of Release Management.
• You are responsible for performing and documenting assigned training in a timely manner, in accordance with the curriculum.
• Your experience in process changes enables you to implement standard processes on time and within budget.
• Furthermore, you manage the execution and documentation of testing activities.
• You are familiar with Agile methods and tools, and you actively participate in projects driven by this methodology.
• You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs), striving for continuous improvement.
  
  

As Senior Process Specialist, you additionally take over the following responsibilities:

• Ensures compliance and validated state of process and systems.
• Collaborate with the Process Management organization to address process-related inquiries from local Key Users.
• Together with the Process Management organization, you are responsible for the complete design and maintenance of efficient global standard processes.

About our future employee

• 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, 21CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation.
• Demonstrated experience in SAP PM module.
• Experience in EHS (SAP solutions) is valuable.
• 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.
• Good/Proficient business English.
  
  

As a Senior Process Specialist, you additionally have:

• Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation.
• Several years of experience in SAP PM module.
• Native/Fluent business English.
• Excellent presentation skills.