Specialist, Validation conducting qualification and validation activities for pharmaceutical projects at Hikma. Collaborating across teams to ensure compliance and effective execution of validation processes.
About the role
- Validation and Calibration Engineer ensuring equipment reliability and product quality in a pharmaceutical environment. Planning, executing, and maintaining validation and calibration activities in compliance with cGMP regulations.
Responsibilities
- Prepare, execute, and review validation protocols (IQ, OQ, PQ) for equipment, utilities, and systems.
- Manage and handle change control processes in coordination with cross-functional teams.
- Develop, review, and update SOPs related to validation, calibration, qualification, and thermal mapping.
- Perform calibration of instruments and document results using SAP or equivalent systems.
- Conduct thermal mapping and requalification studies for controlled areas and storage conditions.
- Review P&IDs, wiring diagrams, and technical documentation.
- Ensure compliance with cGMP, data integrity (ALCOA+), and regulatory requirements.
- Support internal and external audits.
- Perform periodic review and requalification of validated systems.
- Troubleshoot and maintain laboratory and production instruments.
- Coordinate with external calibration vendors and ensure traceability of standards.
- Ensure that the validation activities comply with relevant regulatory requirements, such as FDA, ISPE, WHO, USP, and ISO regulations.
Requirements
- Bachelor's degree in electrical, mechatronics, industrial, or instrumentation engineering (or related field).
- 0–3 years of experience in validation, calibration, or a similar role within a regulated industry (pharmaceutical experience preferred).
- Familiar with electrical systems, pressure and temperature transmitters and gauges.
- Experience with calibration tools (multimeters, calibrators, data loggers).
- Strong MS Office user with good communication skills to build relationships with vendors, suppliers and employees.
- Experience with SAP or computerized maintenance/calibration systems
- Understanding of validation methodologies, failure analysis, and statistical methods.
Benefits
- Health insurance
- Retirement plans
- Paid time off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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