Validation Associate

Performs various validation inspections, cleaning, checks, and tests during the manufacturing process. Compiles, interprets, and records observations of production processes. Identifies, communicates, and assists in the execution of various validation protocols.

Key Duties:

• Conduct performance qualification tests, such as homogeneity studies, to validate equipment performance and consistency in producing reliable results.
• Execute temperature mapping studies to evaluate temperature distribution within equipment and identify potential areas of concern.
• Execute validation studies, ensuring adherence to regulatory requirements and industry best practices.
• Update Standard Operating Procedures (SOPs) and revise documents as needed to reflect current practices and standards.
• Perform cleaning validation procedures, involving rinse and swab sampling tests, to confirm equipment cleanliness and compliance with sanitation guidelines.
• Perform equipment operation qualification tests, including assessing flow rates, temperature settings, and other parameters to ensure equipment operates accurately and reliably.
• Responsible for collecting samples for submission to laboratory for analysis, data entry of deviations, and review data to ensure accuracy, completeness and compliance with established SOPs.
• Verify the proper installation of equipment by conducting thorough inspections and assessments to ensure compliance with regulatory and company standards.
• Responsible to proactively seek opportunities for process improvements and recommend changes to enhance operational efficiency in validation procedures and SOPs.
• Collaborate closely with cross-functional teams to communicate findings and contribute to the enhancement of equipment and processes.

Education Requirements: Bachelor’s Degree required.

Experience Requirements:

• Minimum of 2 years of validation, current Good Manufacturing Practices (cGMP), FDA, and/or manufacturing experience to ensure compliance with regulations.
• Demonstrated experience/proficiency/knowledge/training in a regulated cGMP, manufacturing, or pharmaceuticals environment preferred.

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