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Validation Scientist for Instrumentation

2 months ago

Oceanside California, United States Eurofins USA PSS Insourcing Solutions Full time
Job Overview

Position Summary: The Validation Scientist will be accountable for the validation of computer systems, process automation, equipment, utility systems, and facilities in compliance with established standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs), and all relevant regulatory standards, including GAMP5.

Key Responsibilities:

  • Execute validation test plans in accordance with approved methodologies, ensuring thorough collection of samples and accurate tabulation of test results.
  • Compile and analyze validation data, preparing comprehensive reports and offering recommendations for enhancements.
  • Investigate and troubleshoot any validation-related issues, determining effective solutions.
  • Coordinate validation change control processes and assist in drafting protocols, reports, and data tables.
  • Maintain meticulous documentation related to validation activities.
  • Contribute to the development of procedures and protocols as needed.
  • Oversee contract personnel to ensure successful completion of validation assignments.
  • Engage in cross-functional project teams, collaborating with Development, Manufacturing, Engineering, Quality, and other departments as necessary.
  • Provide guidance and training to validation technicians on a day-to-day basis.
  • Act as a resource for validation technicians, contractors, and vendors.
  • Resolve validation challenges of moderate complexity with minimal supervision.

This role is essential in ensuring that all validation processes meet the highest standards of quality and compliance, contributing to the overall success of Eurofins USA PSS Insourcing Solutions.