Validation engineer and computer systems F/M

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

Validation engineer and computer systems F/M

A multi-specialist player in digital transformation, business consulting and technology consulting, Audensiel supports its clients in all sectors of activity in France and internationally in the following areas:

• Digital: digital transformation projects, from project management using the Agile method through AMOA and application development to acceptance/testing.
• Consulting: IT consulting within IT departments and business consulting within functional departments specifically for Banking, Insurance and the Pharmaceutical Industry in their issues of governance, regulatory compliance, risk management and transformation of financial departments ;
• Data/AI: Architecture and development of Big Data solutions with data engineer and data scientist consultants. Development of innovative artificial intelligence projects for our clients in the form of POC.
• IoT: Exploitation of data from connected objects and their processing within complex interconnected systems. Design of the entire value chain to provide the best user experience for these new services and optimize productivity gains;
• Cybersecurity: Support on the governance of our clients' cybersecurity issues. Audit and project management for data defense and security.
• Cloud/DevOps: Support at different levels of your project, strategy and governance, architecture, development or even DevOps.

• 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;
• Be comfortable with the validation of one/more of the following tools: Excel files, software (SAP, Trackwise, etc.), CRM, laboratory equipment or production with human-machine interface (HMI) type automata.
• You also draft and monitor documents related to validation processes (protocols, procedures, reports, etc.).

With a master's degree, you have knowledge of the pharmaceutical industry processes in the field of validation of computerized systems.

Your rigor and your sense of relationship are essential assets for this position.

In accordance with its ethical commitment, Audensiel is committed to fighting discrimination and promoting diversity and equal opportunities.