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