Senior Validation Scientist - Located In South Carolina

Job Title: Senior Validation Scientist
Reports To: Senior Director of Validation
Salary Range: 60K - 70K

Qualifications:

A technical degree in a scientific field is required. Requires a minimum of 5 years’ experience in cGMP pharmaceutical drug product manufacturing Quality related operations with emphasis on cleaning validation. Experience in managing cleaning validation activities.

JOB SUMMARY

- Designs and conducts validation activities for pharmaceutical products

- Prepares validation protocols and summary reports. Participates in protocol execution activities

- Develops process sampling plans to meet validation requirements and statistical process monitoring requirements

- Ensures cleaning monitoring program is compliant

- Works with Product Development personnel to determine cleaning validation limits and methods

- Calculates MACO limits and other associated cleaning validation limits

- Determines worst case sampling sites for process equipment to ensure clean equipment

- Coordinates the execution of validation exercises with Process Scientists, ensuring successful and timely completion of activities per the established protocol

- Performs successful and on time resolution of incidents and deviations related to validation activities

- Identifies, plans and implements quality/productivity initiatives associated with validation and performance qualification activities based on business needs and priorities

- Trains manufacturing and QC/QA personnel on validation protocol requirements, and maintains documentation archive system in accordance with cGMP and FDA regulations