Cleaning Validation Specialist I

Job Description

Target PR Range: 35-45/hr DOE

Cleaning Validation Specialist

Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.

• Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies
• Supports non-traditional work schedule based on project and business needs
• Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
• Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Proficient with KNEAT execution
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
• Supports the periodic review of cleaning validation studies.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.