To facilitate the introduction of a new product, a new building, clean rooms, utilities, and multiple new production equipments are being established and associated qualification and product validations are needed. Senior Qualification/Validation Experts to support activities are required.
Because of the location this role is partly remote, requiring travel roughly once a month where accommodation will be arranged.
Your activities would include:
- Develop, Review and Execution of project related documentation against current GMP-requirements
- Planning and execution of Computerized Systems Validation (CSV) in cooperation with IT and Process Automation
- Lead and participate in Risk Analysis of equipment, systems and processes
- Issue Formal Commissioning and Qualification Plans, Protocols and Reports and support different Equipment and Systems owners by providing technical knowledge
- Apply professional interdisciplinary project teamwork supporting the team with Engineering department, Qualification Department, Production, EHS in questions regarding GMP-compliant solutions
- Support root cause analyses and troubleshooting activities in case of deviations from Qualification/Validation Perspective
- Support creation, assessment, and completion of change control cases from Qualification/Validation Perspective.
- Contact to the overall project leaders in different departments and within the global project team to support project execution.
Modis is part of the Adecco Group and is in the business of consultancy and professional staffing. We currently employ 500 consultants in the Netherlands and 20,000 worldwide.
The focus of Modis Life Sciences is mainly in the direction of QA, QC, PV, RA, R&D and process engineering profiles within an organization in the fields of Biotech, Food and the Pharmaceutical industry. We have Consultants working at the EMA, Janssen, Sanquin, Astellas, Unilever, Corbion, MSD, Aspen and many more!
We have an exciting new job opportunity as a Validation Engineer at our pharmaceutical client at their location in Friesoythe.
Functie-eisenYou are perfect for this role when you have roughly the following profile:
- Minimum 3 years professional experience in pharmaceutical Industry
- Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods
- Knowledge in automation and computer system validation
- Prior experience with MSD’s quality systems is an advantage.
- Project management knowledge, leadership capabilities with respect to quality topics
- Experience with implementation of new pharmaceutical buildings and new line preferred
- Strong soft skills for the coordination and motivation of interdisciplinary teams in a matrix structure
- Exceptional degree of team spirit, flexibility and robustness
- Proficient communication skills in an English- speaking project environment, good German language skills in spoken and written would be a pré.