Validation & Supplier Qualification Tech Support

Job Description

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.

Full-time