Hikma Pharmaceuticals, a global pharmaceutical company with over 45 years of history, is seeking a Validation Engineer for its site in Sidi Thabet, Tunis, Tunisia. This is a permanent, full-time position (CDI) focused on ensuring the quality and compliance of manufacturing processes and equipment in a regulated environment.
Key Responsibilities
- Develop and execute validation protocols for equipment, processes, and cleaning procedures.
- Perform risk assessments and ensure compliance with cGMP, FDA, and EU regulations.
- Write and review validation documentation, including IQ, OQ, PQ, and process validation reports.
- Collaborate with cross-functional teams (Quality, Engineering, Production) to support validation activities.
- Investigate deviations, non-conformances, and implement corrective actions.
- Maintain validation lifecycle and requalification schedules.
Qualifications and Requirements
- Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related field).
- Minimum of 2-3 years of validation experience in the pharmaceutical or biotechnology industry.
- Strong knowledge of cGMP, validation principles, and regulatory guidelines (FDA, EMA).
- Experience with sterile manufacturing, cleanrooms, and aseptic processing is a plus.
- Excellent problem-solving, documentation, and technical writing skills.
- Ability to manage multiple projects and work in a team-oriented environment.
What We Offer
- Competitive salary and benefits package.
- Opportunity to work with a leading global pharmaceutical company.
- Professional development and training programs.
- Stable, long-term career in a GMP-regulated environment.
Application Tips
- Highlight specific validation projects you have led or contributed to in your CV.
- Mention your familiarity with regulatory standards and validation software or tools.
- Emphasize any experience with process risk assessment (FMEA, HAZOP) or statistical analysis.
- Tailor your cover letter to show your understanding of Hikma's commitment to quality and patient health.