Qualification validation Engineer
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Key Responsibilities
Support the periodic review of qualification status. Execute qualification and validation activities. Lead and support packaging equipment qualification projects. Support implementation and qualification of serialization modules. Perform Computerized System Validation (CSV) activities. Support qualification activities related to manufacturing equipment, utilities, cold rooms and booths/logettes. Identify issues and propose appropriate solutions. Ensure timely execution and follow-up of assigned activities. Collaborate with stakeholders involved in qualification and validation processes. Typical Day: Activities may include: Reviewing qualification documentation and equipment status. Preparing and executing qualification and validation protocols (IQ/OQ/PQ). Supporting packaging line qualification activities. Participating in serialization implementation and qualification projects. Performing CSV documentation and validation activities. Investigating deviations and technical issues. Supporting project activities and maintaining qualification documentation. Coordinating with operational and project teams. The role combines both documentation and hands-on qualification/validation activities. Candidate Profile:
• Must-Have: Minimum 5 years of experience in Qualification & Validation. Proven hands-on experience in qualification and validation of packaging equipment and packaging lines. Experience with serialization projects, including implementation and qualification of serialization modules. Mandatory experience in Computerized System Validation (CSV). Experience writing and executing qualification documentation (URS, Risk Assessments, IQ/OQ/PQ). Ability to perform qualification and validation activities independently. Strong problem-solving skills. Autonomous and proactive mindset. Positive attitude and solution-oriented approach. Fluency in French. Ability to read and write technical documentation in English. Availability and commitment for the full duration of the assignment.
• Nice-to-Have: Experience with Wipotec serialization technology. Experience qualifying utilities, cold rooms and manufacturing equipment. Experience performing periodic qualification reviews. Additional experience within a regulated pharmaceutical environment. Languages: French: Mandatory English: Reading and writing skills required Contact : EL AMERI ROUFAIDAA Talent Acquisition Specialist – Akkodis 📧 Roufaidaa.
EL-AMERI@akkodis.com
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