Validation Engineer – Pharmaceutical Manufacturing

About the role

Hikma Pharmaceuticals is seeking a Validation Engineer to lead validation activities across manufacturing equipment, utilities, facilities, and production processes. The role supports cleaning, process, and computerized system validation projects while ensuring compliance with global regulatory standards.

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 applicable regulations.
• Conduct risk assessments and validation impact assessments for 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 related field.
• 3–5 years of validation experience in pharmaceutical, biotechnology, or medical device environments.
• 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.

Required skills

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