Cleaning Validation Specialist

EQVAL Consulting Group

Las Piedras, PR
Permanent
Full-time

1 month ago
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EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, to perform and provide a highly effective service.We are looking for two Cleaning Validation Specialist with Pharmaceutical (solid dosage) manufacturing experience to develop and execute the cleaning validation process.
Essential Functions:

Perform assessments on Cleaning Test Methods, including drive, implement and/or support actions towards findings resolution and implementation.
Development and execution of Cleaning Validation Protocols, including data analysis.
Lead and/or participate in different Cleaning Validation activities.
Support Cleaning Validation activities and Compliance such as preparing or reviewing validation documentation.

Requirements:

Knowledge in Cleaning Methods best practices based on pharmaceutical FDA regulation.
Experience in Test Methods analysis and execution, including ‘hands-on’ experience performing laboratory methods and its documentation process.
Knowledge in USP Guidelines and ICH Guidelines for Stability
Experience in Cleaning Validation activities, including protocols development and execution (URS, DS, Risk Assessments, IQ, OQ, PQ).
5+ years of experience in Cleaning Validation.
Excellent technical writing skills (both English and Spanish)
BS in Sciences or Engineering required.

EQVAL Consulting Group