Validation Specialist

3 weeks ago


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

We are seeking a highly skilled Validation Specialist to join our team at Eurofins USA PSS Insourcing Solutions. As a key member of our quality assurance team, you will be responsible for ensuring the validation of computer systems, process automation, equipment, utility systems, and facilities.

Key Responsibilities
  • Execute test plans according to approved procedures, collect samples, tabulate test results, and organize data packages.
  • Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements.
  • Investigate and troubleshoot problems that occur and determine solutions.
  • Coordinate and execute validation change control and preparation of draft protocols, reports, and data tables.
  • Maintain all documentation pertaining to validation.
  • Assist in developing procedures and/or protocols.
  • Coordinate contract personnel through completion of assignments.
  • Participate on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
  • Provide day-to-day guidance and training to other validation technicians.
  • Serve as an information resource to validation technicians, contractors, and vendors.
  • Resolve validation issues of moderate scope with limited direct supervision.
Requirements

To be successful in this role, you will need to have a strong understanding of regulatory requirements, including GAMP5, and be able to apply this knowledge to ensure the validation of computer systems and processes. You will also need to have excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.



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