Senior Calibration and Validation Engineer

The Validation department is responsible for the development, implementation and improvement of different calibration and validation activities in accordance with cGMP guidelines. You are the team coordinator and make sure that all activities are executed as plannend.

You are responsible for:

• Writing and executing validation documentation in line with the Site Validation Master Plan.
• Daily Planning and coordination validation and qualification activities in your team.
• Managing deviations, changes and CAPA’s to ensure that these are well documented and that corrective actions are taken and followed-up.
• Coordination of calibration activities
• Supporting and participation in Corporate and Regulatory audits

• Master’s degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
• 4 years' experience in Calibration/Validation/Quality systems - Project management experience –
• Excellent communication skills, fluency in English
• Familiar with Quality Management and GxP Regulations
• Knowledge of Validation Methodologies
• Knowledge of Quality Systems, European and FDA regulations and cGMP
• Team player, project proficiency and autonomy expected