Validation Engineer

Opdrachtgever

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

Diploma level 4 with at least 6 year experience or Bachelor with at least 4 year experience
GMP experience in pharmaceutical or relevant industries
Validation experience (URS - PQ)
Fluent in English, Dutch is a pre
On site available
Able to work in multicultural environment

Perform routine commissioning, qualification, and validation (CQV) activities, including temperature mapping and related validation tasks.
Create and execute CP/IQ/OQ/PQ protocols for equipment, utilities, facilities, and computerized systems, including identification and resolution of exceptional conditions.
Conduct investigations and implement corrective or preventive actions related to deviations, exceptional conditions, and CAPAs.
Support coordination of calibration and certification activities for validation instruments.
Review technical documentation, including protocols, summary reports, testing records, and validation lifecycle SOPs.
Develop and maintain Computerized System Validation (CSV) documents such as risk assessments, validation plans, UATs, and final reports.
Partner with Quality Engineering to establish and maintain CSV and CQV strategies and procedures.
Provide CQV and CSV guidance during project planning, design, and execution phases.
Manage contractors involved in equipment, system, or facility commissioning, qualification, and validation.
Develop or review technical specifications required for CQV lifecycle documents.
Support vendor protocol execution as needed.
Perform other duties as assigned; tasks may be delegated to qualified deputies when appropriate.