Website Calsoft Labs
Calsoft Labs
Company : Calsoft Labs
Ideal Candidate: 5+ YOE with a B.S. in Science, Engineering, and Pharmacy areas.
Standard Hours – hours may vary to support manufacturing (early/later shifts, possible weekends)
Cleaning Validation Specialist I Job Description
Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.
" Support authoring and executing RESUME/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 RESUME program
" Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
" Leads and performs on floor RESUME 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.