Validation Engineer (m/f/x)

The Validation Engineer will be responsible for the execution of process and software validation activities under the
organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure
compliance within external and internal requirements and ensure compliance with the quality management system.

Major areas of accountability

• Performing their job in compliance with the guidelines given;
• Drawing attention to the manager to any difficulties in understanding or following the guidelines;
• Drawing attention to inefficiency of the system;
• Ensure continuous improvement of processes & specifications;
• Provide sparring and support for Operations in CMPT regarding quality issues and help improve overall quality understanding during validations;
• External / internal Audit support;
• Maintain high quality understanding in operations through support and guidance of operators daily;

Essential Duties / Responsibilities
Below duties & responsibilities apply when the site opens for production or when applicable training is performed for each of the topics where such training is required.

General:

• Issuing, completing, or approving validation documentation (protocols, deviations, reports, etc.);
• Performing Installation, Operational, and Performance Qualification of equipment, instruments, and machines;
• Performing validation of test methods for continues data and attributes;
• Performing assessment about software changes and perform validation of software as appropriate;
• Creation of software validation plans and validation strategic plans as required;
• Issuing, updating, and approving Process Risk assessments;
• Investigating abnormal test results (close collaboration with Quality Engineer and Production Support Engineers and stakeholders);
• Troubleshooting validation issues (close collaboration with Quality Engineer and Production Support Engineers and stakeholders);
• Handling of Process validation, Software validation and Risk assessments related Change Request tasks;
• Collecting, organizing, and documenting test data;
• Statistical analysis of data for process and test methods validation;
• Ensuring accurate records of all validation activities.
• Maintaining validation documentation throughout the validation life cycle.
• Participation on cross-functional teams related to projects for new machines, transfer machines, item extensions or any other project where validation assessment or validation activity is needed;
• Take responsibility for those safety aspects identified for the given position.

Department:

• Support Validation Training in FEL Quality

• Cross-functional: Self-management, decision making and critical thinking, collaboration & communication.
• Functional competencies: Coloplast specific knowledge of quality management system and processes.
• Fluent in both spoken and written English