The Laboratory Equipment Validation Specialist<\/b> 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 <\/b>systems and densitometer<\/b>. The specialist will support laboratory operations by maintaining validated states and ensuring data integrity and regulatory compliance.
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Key Responsibilities
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Plan, execute, and document laboratory equipment validation activities.
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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.
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Ensure compliance with cGMP.
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Requirements<\/h3>
Bachelor’s degree in Science, or a related scientific discipline.
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Minimum of three (3) years of relevant experience in a regulated laboratory in pharmaceutical environment.
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Demonstrated hands on experience in the validation of UPLC systems and densitometer<\/b>.
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Strong knowledge of equipment qualification and validation requirements, data integrity principles, and applicable regulatory expectations.
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Bilingual in English and Spanish (written and spoken).
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Excellent technical writing, organizational, and communication skills.
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