Ingénieur validation/Ingénieure validation
Il y a 2 jours
Jette, Brussels, Belgique
Akkodis
Temps plein
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AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.
As part of the development of the activities at one of our clients, we are looking for a Validation Engineer.
Missions:
• Plan, execute and document qualification and validation activities (IQ/OQ/PQ).
• Perform equipment, utilities, process and cleaning validation.
• Prepare and review validation protocols, reports and risk assessments.
• Manage deviations, CAPAs and change controls related to validation activities.
• Ensure compliance with GMP requirements and applicable regulatory guidelines.
• Collaborate with QA, Production, QC and Engineering teams.
• Support audits, inspections and periodic reviews to maintain the validated state. Background:
• Bachelor’s or Master’s degree in Engineering, Biotechnology, Chemistry, Pharmacy or a related scientific field.
• Minimum 3–5 years of experience in validation or qualification within the pharmaceutical industry.
• Good knowledge of GMP regulations and pharmaceutical quality systems.
• Hands-on experience with IQ/OQ/PQ protocols and validation documentation.
• Familiarity with risk assessments, deviations, CAPA and change control.
• Experience in process, equipment, cleaning validation or computerized system validation (CSV) is an asset.
• Fluency in English; French and/or Dutch is an advantage. Contact: Roufaidaa.
EL-AMERI@akkodis.com Roufaidaa El Ameri Talent Acquisition Specialist
Missions:
• Plan, execute and document qualification and validation activities (IQ/OQ/PQ).
• Perform equipment, utilities, process and cleaning validation.
• Prepare and review validation protocols, reports and risk assessments.
• Manage deviations, CAPAs and change controls related to validation activities.
• Ensure compliance with GMP requirements and applicable regulatory guidelines.
• Collaborate with QA, Production, QC and Engineering teams.
• Support audits, inspections and periodic reviews to maintain the validated state. Background:
• Bachelor’s or Master’s degree in Engineering, Biotechnology, Chemistry, Pharmacy or a related scientific field.
• Minimum 3–5 years of experience in validation or qualification within the pharmaceutical industry.
• Good knowledge of GMP regulations and pharmaceutical quality systems.
• Hands-on experience with IQ/OQ/PQ protocols and validation documentation.
• Familiarity with risk assessments, deviations, CAPA and change control.
• Experience in process, equipment, cleaning validation or computerized system validation (CSV) is an asset.
• Fluency in English; French and/or Dutch is an advantage. Contact: Roufaidaa.
EL-AMERI@akkodis.com Roufaidaa El Ameri Talent Acquisition Specialist