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.

Responsibilities

• 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.).

Qualifications

• 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.