Check with seller Senior Validation Engineer Rocky Mount

  • Location: Rocky Mount, North Carolina, United States










ROLE SUMMARY

As a Senior Validation Engineer you will be responsible for validating/qualifying the systems used to manufacture drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

ROLE RESPONSIBILITIES

Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
Coordinates and communicates all testing with affected functional groups and evaluates test results.
Executes validation studies to include protocol preparation, scheduling, protocol execution, analysis of data and final report generation.
Participates in presentation of results to Regulatory Agencies when necessary.
Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
Participate and/or lead discussions with internal, customer and regulatory agencies
Prepare responses to internal, customer and regulatory agency audits
Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
May supervise and/or mentor junior level engineers.

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