You will play a part in the validation of all critical systems used for the production, manufacture and distribution of pharmaceutical or medical products, ensuring they meet the necessary performance and safety criteria. 

Your missions will be the following:  

• Qualification of equipment and installations: carry out the qualification of production equipment, installations and systems in accordance with regulatory requirements (GxP, FDA, EMA, etc.). 

• Prepare and implement qualification protocols (IQ/OQ/PQ) and write qualification reports. Ensure that equipment and installations comply with functional and operational specifications and meet safety, performance and reliability requirements. 

• Validation of processes and systems: perform the validation of manufacturing processes and automated systems (such as production control and management systems) to guarantee their compliance and effectiveness. 

• Draft and implement validation protocols for processes and computerised systems (CSV – Computer System Validation). 

• Perform validation tests, analyse the results and write detailed validation reports. 

• Regulatory compliance and monitoring: ensure compliance with local and international regulations regarding qualification and validation (e.g. GMP, FDA, EMA). 

• Participate in internal and external audits to verify the compliance of qualified equipment, installations and validated systems. 

• Implement and follow up on corrective and preventive actions following discrepancies or deviations observed during qualification/validation processes. 

• Training and knowledge transfer: train internal teams in the qualification and validation of equipment and processes. 

• Provide technical support and advice on qualification and system validation best practices. 

• Documentation management: draft and keep up to date the technical documentation necessary for qualification/validation (protocols, reports, technical data sheets, etc.). 

• Ensure that all documentation complies with regulatory requirements and is accessible during inspections or audits. 

• Continuous improvement and change management: participate in the continuous improvement of qualification/validation procedures to optimise processes and ensure compliance. 

• Manage changes in equipment or systems, ensuring that requalification or revalidation is performed in accordance with requirements. 

The profile we are looking for: 

With a Master’s degree (Bac +5) in Biotechnological Engineering, Engineering, Pharmacy, or a similar field. You have 3 to 5 years of experience in qualification/validation within the pharmaceutical or biopharmaceutical industry. 

Technical skills: 

• In-depth knowledge of regulations relating to qualification and validation (GxP, FDA, EMA, etc.). 

• Expertise in drafting and implementing qualification protocols (IQ/OQ/PQ) and computerised systems validation (CSV). 

• Proficiency in equipment and industrial process qualification and validation tools and methodologies. 

Personal skills: 

• Ability to work independently as well as in a team, in a dynamic and regulated environment. 

• Excellent communication skills to interact with various departments and regulatory authorities. A strong sense of organisation, rigour and priority management.