Csv engineer

We are looking for a CSV Engineer for one of our clients based in Braine-l’Alleud.

• key responsibilities

As a CSV Engineer, you will :

• Define and monitor CSV qualification strategies that affect the OMP project,
• Identify the implementation approach for these strategies (Change Control, others),
• Determine validation impacts based on the supplier's release notes,
• Assess compatibility with existing software/firmware,
• Understand, apply, and communicate validation prerequisites,
• Identify and control project risks,
• Draft qualification documents in accordance with the SOPs,
• Plan, organize, and coordinate validation activities, in conjunction with the project team,
• Execute and/or verify installation qualification tests by involving future users and/or the supplier and in accordance with applicable procedures,
• Go into the field to supervise and improve compliance during the execution of verification/qualification tests by technical SMEs/System Owners,
• Report to management any issues impacting the implementation schedule or the progress of the mission,
• Support or take responsibility for Responsible for activities related to continuous improvement,
• Ensure compliance with current legislation and standards as well as internal safety rules.
• qualifications

Here are the requirements as a CSV Engineer:

• Bachelor's or Master's degree, preferably with a focus on IT/industrial automation and otherwise, in a scientific field.
• Five years of experience in validation, including at least three years on automated and/or computerized systems, particularly software/firmware updates/upgrades/revamping.
• Understanding of validation workflows, practices, methodologies, and deliverables.
• Proven knowledge of the automation side of pharmaceutical industrial processes (washers, glove testers, RABS, isolators, crimpers, fillers, sealers, depyro tunnels, autoclaves, filter testers, CIP/SIP stations, data acquisition systems, tablet presses, mixers, visual inspection systems, serialization systems).
• Proven knowledge of laboratory equipment (NMR, electrophoresis, UV-Vis spectroscopy, FTIR spectroscopy, qPCR, MALDI TOF, etc.). - Knowledge of design parameters and elements that can impact quality on the aforementioned processes.
• Knowledge of IT/Computer System Validation techniques.
• Fluency in English and comprehension.
• Ability to take responsibility and make decisions.
• Ability to maintain good relationships with project stakeholders.
• Persuasive and assertive skills.
• Research and analyze the causes of failures and propose innovative solutions to address them.
• Ability to connect concepts and take a step back (helicopter view).
• Autonomous and flexible.
• Ability to understand, follow through, and implement decisions made with the line manager.
• Analytical mind and strong logical reasoning skills.
• Methodical, rigorous, proactive, and organized.
• Quality and customer-oriented (CSV manager). - Ability to work in a team and support colleagues, communicating and speaking with one voice.
• Honesty, ethics, respect, and integrity.
• Ability to coordinate multiple projects simultaneously.

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