Commissioning & Qualification Engineer
Akkodis Belgium is looking for an experienced professional in a pharmaceutical environment with expertise in Commissioning & Qualification.
Key Responsibilities:
• Provide guidance and manage suppliers for Commissioning & Qualification activities, from design to field execution and report approval.
• Draft, coordinate review and approval of Commissioning & Qualification documents, including User Requirements Specification (URS), Quality Risk Assessment (QRA), Systems Requirement Specification (SRS) and others.
• Generate and review Change Controls related to Commissioning & Qualification.
• Drive verification testing, protocol execution, walk-downs, verification of system drawings and troubleshoot as required.
• Responsible for Planning, Tracking and Reporting of Commissioning & Qualification status and risks/issues for selected systems.
• Conduct deviation investigation and resolution, take appropriate corrective actions as needed.
• Ensure safe and coordinated start-up of equipment/system.
Industry: Life sciences
Requirements:
• Bachelor or Master's degree in Engineering or Life Sciences with relevant experience.
• Experience delivering Commissioning and Qualification for Pharmaceutical/Biotechnology projects.
• Knowledge of GxP regulations.
• Understanding of risk-based approach to Commissioning & Qualification.
• Fluent in French and English.
What We Offer:
As an Akkodis Team Member, you will enjoy:
• Onboarding via buddy process.
• Support for career development by Business Manager.
• Autonomy in training plan and personal/professional growth.
• Permanent contract.
• Competitive salary package including extra-legal benefits.