What are the responsibilities and job description for the Cleaning Validation Specialist I position at Planet Pharma?
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.
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.