Validation Specialist

The Validation Specialist is responsible for supporting qualification and validation activities for manufacturing equipment and processes. The role focuses on the execution of IQ, OQ, and PQ protocols, development and maintenance of SOPs, risk management activities such as PFMEA, and cleaning validation. This position ensures compliance with applicable regulatory requirements and internal quality standards across multiple manufacturing machines and systems.

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Key Responsibilities

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Execute and document equipment qualification activities, including Installation Qualification (IQ)<\/b>, Operational Qualification (OQ)<\/b>, and Performance Qualification (PQ)<\/b> for manufacturing equipment and systems.

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Develop, review, update, and maintain Standard Operating Procedures (SOPs)<\/b> related to validation, equipment operation, and cleaning processes.

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Lead or support Process Failure Modes and Effects Analysis (PFMEA)<\/b> and other risk assessment activities for new and existing equipment.

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Perform and support Cleaning Validation<\/b> studies, including protocol development, execution, sampling, and final reports.

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Experience conducting or supporting PFMEA<\/b> and risk management activities.

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Knowledge of Cleaning Validation<\/b> principles and execution.

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Experience working with different types of manufacturing equipment and/or machinery<\/b>.

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Familiarity with GMP regulations and FDA guidelines.

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Requirements<\/h3>

Bachelor’s degree in Engineering, Life Sciences, or a related field.

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Bilingual (Spanish/English)

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Computer literacy<\/li ul div>

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