We are actively expanding our team and seeking dedicated Validation Engineers across multiple experience levels (1 to 10 years) to support critical manufacturing and quality processes within the Pharmaceutical and Biomedical sectors.Whether you are in the early stages of your career with foundational cGMP experience, or a seasoned professional capable of developing Validation Master Plans (VMP) and leading site-wide validation efforts, we have an opportunity that aligns with your expertise.Key Responsibilities:Protocol Execution: Author, execute, and review validation protocols (IQ, OQ, PQ) for pharmaceutical manufacturing equipment, utility systems, and laboratory instruments.Process & Cleaning Validation: Support and execute process validation, cleaning validation (CIP/SIP), and tech transfer activities in aseptic and biologics manufacturing environments.Compliance & Documentation: Ensure all validation activities comply with FDA, cGMP, and internal Quality Management System (QMS) requirements. Manage deviations, CAPAs, and change controls related to validation.System Testing: Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new biomedical and pharmaceutical equipment.Risk Management: Conduct risk assessments (FMEA) and trace matrices to ensure robust qualification of manufacturing processes.Role Requirements:Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Biotechnology, Pharmaceuticals, or a closely related scientific field.1-10 years of hands-on validation experience strictly withtech, or Medical Device industries.Deep understanding of cGMPs, FDA 21 CFR Part 210/211, FDA 21 CFR Part 11, and relevant ISO standards.

Validation Engineer

Emma

Requirements and responsibilities

Skills wanted:

Language(s) required:

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