Validation Engineer II
Amsterdam | GMP | +3 years exp. | CQV & CSV | Equipment Lifecycle | CP/IQ/OQ/PQ | Temp Mapping
Your new role
As a Validation Engineer you will have numerous responsibilities which will include but not limited to:
- Performing 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.
What you'll need to succeed
- MBO level 4 with at least 6-years' experience or HBO with at least 4 years' experience
- GMP experience in pharmaceutical or relevant industries
- Validation experience including CQV, CSV documentation, Equipment Lifecycle, Temperature mapping and qualifications.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (€70,000) and your travel expenses are covered.
Your new company
Our client is dedicated to achieving one of the most ambitious goals of 21st‑century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. They have been at the forefront of cancer immunotherapy and today are a leader in engineered T‑cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago.
With an unrelenting drive and a singular focus on cell therapy, their team is executing on a strategy to bring life‑saving therapies to patients.
With their brand‑new production site in Hoofddorp, they are dreaming big. Now you can get the chance to be a part of this journey.
Hays