MF01-120225 Commissioning & Qualification (C&Q) Services

Department: Field - MF Location: Aguadilla, 005
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Commissioning & Qualification (C&Q) Services For: Class 5 Manufacturing Rooms. .ISO 14644 testing For: Utilities and Facilities Qualifications To Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and Reports

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

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