Senior Validation Engineer – Computerized Systems (Pharma)

Audensiel; Lyon; Sur place; EUR 45 000 - 75 000; Plein temps

Résumé du poste

Audensiel is seeking a Validation engineer to support the validation of computerized systems in the pharmaceutical industry. The role focuses on master planning, risk analyses, and execution of IQ/OQ/QP tests within GMP contexts.

The candidate will write URS, test sheets, and qualification reports, collaborating with cross-functional teams to ensure compliance and data integrity across projects in France and internationally.

Qualifications

• Master's degree in pharmaceutical validation or related field.
• Knowledge of validation principles for computerized systems in pharma.
• Experience with GMP/compliance environments is a plus.

Responsabilités

• Write the validation master plan (POS or VMP).
• Participate in risk analyses.
• Establish and monitor the validation schedule.
• Identify and monitor key users.
• Write URS, test sheets and define user needs.
• Write qualification protocols, run IQ/OQ/QP tests and write qualification reports.
• Validate tools such as Excel files, SAP, Trackwise, CRM, and lab equipment with HMI.

Connaissances

Risk analysis

Validation planning

Requirement gathering

Documentation

Formation

Master's degree in pharmaceutical validation or related field

Outils

SAP

Trackwise

CRM

Excel

Description du poste

Audensiel is seeking a Validation engineer to support the validation of computerized systems in the pharmaceutical industry. The role focuses on master planning, risk analyses, and execution of IQ/OQ/QP tests within GMP contexts.

The candidate will write URS, test sheets, and qualification reports, collaborating with cross-functional teams to ensure compliance and data integrity across projects in France and internationally.