Validation & Supplier Qualification Tech Support

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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:

• Validation & Supplier Qualification Tech Support

Description:

• Execution and technical documentation of IQ/OQ/PQ validations, including protocol development, final reports, and statistical analysis of results.
• Hands-on experience in Process Validation, Equipment Qualification, and Computer System Validation (CSV) in compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP requirements.
• Development and execution of Supplier Qualification, including technical audits, process capability analysis (Cp, Cpk), and risk assessment under ISO 14971.
• Technical investigation of deviations and non-conformances, applying Root Cause Analysis tools (5 Whys, Fishbone) and supporting CAPA implementation.
• Technical support for product transfers, engineering changes (ECO/ECN), and revalidation of critical processes.

Qualifications:

• Bachelor's Degree in Engineering or Science.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.