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.

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.

Validation Engineer

Key skills