Validation Specialist

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related discipline required.
• 5+ years of hands-on validation experience with GMP equipment and utilities.
• Strong understanding of cGMP, GDP, and SOP requirements.
• Experience with validation documentation generation.
• Knowledge of temperature mapping and controlled temperature units.

Responsibilities

• Support cleaning validation activities and protocol execution.
• Perform temperature mapping and requalification of controlled temperature units.
• Execute IQ/OQ/PQ for GMP equipment and utilities.
• Assist in commissioning and qualification of new or modified equipment.
• Generate validation documentation in compliance with regulatory requirements.
• Support validation lifecycle activities and change control processes.
• Participate in audit readiness and regulatory inspection support.

Benefits

• Collaborative work environment with cross-departmental interaction.
• Opportunities for professional development and training.
• Exposure to a variety of equipment and technologies.
• Involvement in regulatory inspections and compliance activities.