Validation Specialist

About the role

Hikma Pharmaceuticals is seeking a Validation Specialist to lead validation activities for 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, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (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 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.
• Monitor the validated state of systems and recommend improvements to validation processes.

Required profile

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry or a 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.
• Excellent analytical, problem‑solving and documentation skills.
• Effective communication and ability to work in cross‑functional teams.

Required skills

• Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
• GMP, FDA 21 CFR Part 11, GAMP 5, Annex 11.
• Risk assessment and CAPA.
• Cleaning validation, process validation, computerized system validation (CSV).
• Microsoft Office applications.