Validation Engineer

Holly Springs, NC, US • Posted 8 days ago • Updated 7 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Science
Pharmacy
Facilitation
Technical Support
Management
Root Cause Analysis
Collaboration
Project Planning
Manufacturing
Quality Control
Quality Assurance
Documentation

Summary

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 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91160181
Position Id: 17df0594406f9e1668b561ae38c3dac4
Posted 8 days ago

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