Validation Associate
- Location: 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 regulations
- Compensation: $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 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 & 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 & 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
Qualifications – Validation Associate:
- Bachelor’s Degree required
- 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
LOCAL CANDIDATES ONLY PLEASE
