Production and Manufacturing Execution Process Specialist (Produce to Quality)
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 Demand to Deploy. 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 P2Q Process Specialist in the area of Production and Manufacturing Execution, you will be able to coordinate and propose solutions within the Demand Management process, as well as actively take part of Change and Release Management for P2Q.
Tasks & responsibilities
As a Process Specialist (Production and Manufacturing Execution), you are responsible for:
- Ensuring that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community.
- Acting as a P2Q Process Specialist, you support our daily operation of processes and applications.
- Ensuring that our processes and systems are always compliant and in a validated state.
- Managing the execution and documentation of testing activities.
- Ensuring the implementation and continuous improvement of our standardized processes in global projects.
- Based on strong communication skills, you will be managing stakeholder interactions successfully and define the level of standardization for our processes and / or systems.
- 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
- Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
- Experience in pharmaceutical or biopharmaceutical production or supporting areas (e.g. quality assurance in production) would be a strong asset
- 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 (we are also open to candidates with experience in validating production processes).
- Experience in Production & Manufacturing (e.g. MES, PAS-X or SAP PP-PI or similar) required.
- Experience in Label management and Product Safety & Security (PSS) would be an advantage.
- 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.
Additionally, we are looking for:
- 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.
- Excellent business English.