Ingénieur Validation – Pharmaceutique

About the role

We are looking for a talented Validation Engineer to join us. At Hikma you’ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all.

Key responsibilities

• Develop, review, and execute validation protocols and reports (IQ, OQ, PQ).
• Lead validation activities for manufacturing equipment, utilities, facilities, and production processes.
• Support cleaning validation, process validation, and computerized system validation (CSV) projects.
• Ensure compliance with GMP, FDA, EMA, WHO and other regulatory requirements.
• Conduct risk assessments and validation impact assessments related to changes, deviations, and CAPA activities.
• Review technical documentation, SOPs, and validation master plans.
• Collaborate with Quality Assurance, Engineering, Production, and Regulatory Affairs teams.
• Participate in internal audits, regulatory inspections, and customer audits.

Required profile

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry or related discipline.
• 3–5 years of experience in validation within a pharmaceutical, biotechnology or medical device environment.
• Strong knowledge of GMP regulations and validation lifecycle principles.
• Experience with qualification of manufacturing equipment and utilities.
• Familiarity with FDA 21 CFR Part 11, GAMP 5, Annex 11 and data integrity requirements.
• Strong analytical, problem‑solving and documentation skills.
• Excellent communication skills and ability to work in cross‑functional teams.
• Proficiency in Microsoft Office applications.

Required skills

• Microsoft Office
• FDA 21 CFR Part 11
• GAMP 5
• Annex 11
• Data integrity