Qualification/Validation Engineer F/M

Audensiel; Lyon; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A key player in digital transformation is seeking a professional in Lyon to participate in qualifying pharmaceutical installations and drafting important protocols. You will ensure thorough management of specific equipment while being rigorously organized and committed to quality. A Master’s degree related to the pharmaceutical industry and understanding of qualification processes is essential. The company promotes diversity and equal opportunities.

Qualifications

• Experience in drafting qualification protocols and dossiers.
• Knowledge of qualification and validation phases.
• Ability to manage document control and standardization.

Responsabilités

• Participate in the execution of qualification protocols.
• Conduct on-site installations' qualification phases.
• Ensure management of specific equipment for qualification controls.

Connaissances

Knowledge of pharmaceutical industry processes

Rigor

Relationship management

Formation

Master's degree

Description du poste

Overview

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.

Participate in the execution of industrial projects (mainly in the pharmaceutical sector): drafting of qualification protocols, drafting of dossiers.

Participate in the qualification phases of on-site installations (acceptance, assembly validation, Instrumental qualification, operational qualification, performance validation, lifting of reservations...).

Ensure specific missions of delegation, standardization, document management and management of specific equipment (in particular equipment to ensure controls in qualification).

With a master’s degree, you have knowledge of the pharmaceutical industry processes in the field of qualification/validation.

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

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