Title:  Engineer, Validation

Job Summary:

We are seeking a detail-oriented Validation and Calibration Engineer with a strong background in instrumentation and measurement systems within a pharmaceutical environment. The role involves planning, executing, and maintaining validation and calibration activities in compliance with cGMP and regulatory requirements to ensure equipment reliability, product quality, and data integrity.

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Key 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.

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Requirements:

Education & Experience:

• 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).

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Technical Skills:

• 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.

Soft Skills:

• Strong analytical and problem-solving skills.
• Effective communication and teamwork abilities.
• Attention to detail with a strong quality mindset.
• Hands-on and proactive approach.