Validation Engineer – Pharmaceutical Manufacturing

About the role

Hikma Pharmaceuticals is seeking a Validation Engineer to join its Sidi Thabet site. You will work within a collaborative environment that values innovation, care, and teamwork, supporting the company’s mission to deliver high‑quality medicines worldwide.

Key responsibilities

• Develop, review, and execute validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Lead validation activities for manufacturing equipment, utilities, facilities and production processes.
• Support cleaning, process and computerized system validation (CSV) projects.
• Ensure compliance with GMP, FDA, EMA, WHO and other applicable regulations.
• Conduct risk assessments and 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.
• Monitor the validated state of systems and recommend improvements.

Required profile

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry or a related discipline.
• 3–5 years of validation experience in a pharmaceutical, biotechnology or medical‑device environment.
• Strong knowledge of GMP regulations and the validation lifecycle.
• Experience with qualification of manufacturing equipment and utilities.

Required skills

• GMP
• FDA 21 CFR Part 11
• GAMP 5
• Annex 11