About The Position

The Laboratory Equipment Validation Specialist is responsible for the validation and lifecycle management of laboratory equipment used in a regulated pharmaceutical environment. This role ensures compliance with cGMP regulations through the planning, execution, and documentation of validation activities for analytical instruments, with a strong focus on UPLC systems and densitometer. The specialist will support laboratory operations by maintaining validated states and ensuring data integrity and regulatory compliance.

Requirements

  • Bachelorachelor’s degree in Science, or a related scientific discipline.
  • Minimum of three (3) years of relevant experience in a regulated laboratory in pharmaceutical environment.
  • Demonstrated hands-on experience in the validation of UPLC systems and densitometer.
  • Strong knowledge of equipment qualification and validation requirements, data integrity principles, and applicable regulatory expectations.
  • Bilingual in English and Spanish (written and spoken).
  • Excellent technical writing, organizational, and communication skills.

Responsibilities

  • Plan, execute, and document laboratory equipment validation activities.
  • Develop, review, and approve validation protocols, reports, risk assessments, and traceability matrices.
  • Perform validation of analytical laboratory instruments, including UPLC systems and densitometer, as well as other laboratory equipment as assigned.
  • Ensure compliance with cGMP.
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