Validation Specialist

Validation AssociateLocation: Boca Raton, Florida (LOCAL CANDIDATES ONLY PLEASE)In-office, full time position Requires a minimum of 2 years of validation, current Good Manufacturing Practices (cGMP), FDA, and/or manufacturing experience to ensure compliance with regulationsCompensation: $58,000 to $60,000 (non-exempt position with overtime eligibility); competitive benefits package SUMMARY: 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.Responsibilities– Validation Associate:Conduct performance qualification tests to validate equipment performance & consistency in producing reliable resultsExecute temperature mapping studies to evaluate temperature distribution within equipment and identify potential areas of concernExecute validation studies, ensuring adherence to regulatory requirements & industry best practicesUpdate Standard Operating Procedures (SOPs) and revise documents as needed to reflect current practices and standardsPerform cleaning validation procedures, involving rinse and swab sampling tests, to confirm equipment cleanliness and compliance with sanitation guidelinesPerform equipment operation qualification tests, including assessing flow rates, temperature settings, and other parameters to ensure equipment operates accurately and reliablyResponsible for collecting samples for submission to laboratory for analysis, data entry of deviations, and review data to ensure accuracy, completeness, and compliance with established SOPsVerify the proper installation of equipment by conducting thorough inspections and assessments to ensure compliance with regulatory & company standardsResponsible to proactively seek opportunities for process improvements and recommend changes to enhance operational efficiency in validation procedures and SOPsCollaborate closely with cross-functional teams to communicate findings and contribute to the enhancement of equipment and processesQualifications – Validation Associate:Bachelor’s Degree requiredMinimum of 2 years of validation, current Good Manufacturing Practices (cGMP), FDA, and/or manufacturing experience to ensure compliance with regulationsDemonstrated experience / proficiency / knowledge / training in a regulated cGMP, manufacturing, or pharmaceuticals environment preferredLOCAL CANDIDATES ONLY PLEASE