Validation Engineer

Location: Sidi Thabet

Job Type: CDI

About Us

For over 45 years, Hikma Pharmaceuticals has been putting better health within reach, every day, by creating high-quality medicines and making them accessible to those who need them. We are helping to shape a healthier world that enriches all our communities, and our global team of 9,500+ empowered employees are central to this mission.

As a trusted and reliable partner of over 800 high-quality generics, specialty and branded pharmaceutical products, we are driven to improve access to medicine. Through our 29 manufacturing plants, 9 R&D centers across the MENA, North America and Europe, our footprint allows us to play a critical role in serving patients. 

Description:

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. We’re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together.

Key Responsibilities

• Develop, review, and execute validation protocols and reports, including:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • 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, standard operating procedures (SOPs), and validation master plans (VMPs).
• 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.

Qualifications & Experience

Required

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related discipline.
• Minimum 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.

Preferred

• Experience with sterile manufacturing, aseptic processing, or cleanroom environments.
• Knowledge of process validation, cleaning validation, and computerized system validation.
• Certification in validation, quality, or pharmaceutical engineering is an advantage.

Key Competencies

• Attention to detail
• Regulatory compliance mindset
• Project management skills
• Technical writing and reporting
• Continuous improvement orientation
• Teamwork and collaboration