Change Control Engineer (FH)

Grow with us - Your Responsibilities

• Ensure that each change is performed in compliance with the change management process as per the process definition

• Collaborate with change control contributor (Quality Engineering PLCM (MSAT) ONS) to prepare gate meetings with the target of submitting the change to the validation of the Change Control Committee

• Lead the Change Control Committee

• Take decision on quality requirements related to the change control management or escalate to Quality management in case of critical situation derogation to process or drift in change management process

• Communicate with customers during audits.

• Implement improvements to the change management process at procedure instruction and form levels

• Provide training about Change management process to the stakeholders of changes or colleagues requiring access to change control information.

• Leads or participates to non-conformities investigation and definition of CAPA plan

• Leads or participates to continuous improvement projects/initiatives related to Quality Change management and technical data management

• Develop and maintain the documentation system with a high level of clarity legibility.

What will convince us

• Master degree in Science Engineering or related field

• Minimum 5 years related experience required

• Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems

• Knowledge of quality systems and product/process lifecycle management within a manufacturing environment

• Proficient computer skills required

• Excellent communications skills both written and oral including ability to navigate potentially challenging situations

• Ability to quickly assess assigned task requirements identify potential challenges and communicate effectively in order to expedite the successful execution of assigned work

• Efficient organizational skills including the ability to manage multiple processes and priorities effectively

• Good command of spoken written English

About Sartorius

Sartorius is part of the solution in the fight against cancer dementia and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.
Experience:

IC