Validation Specialist II

Responsibilities

• Conducts computer system validations to ensure adherence to GxP regulations, including 21 CFR Parts 210, 211, and 820, as well as compliance with Good Automated Manufacturing Practice (GAMP) standards.
• Ensures that change controls, records, and procedures align with current Good Manufacturing Practices (cGMP) and regulatory expectations.
• Collaborates with cross-functional teams to coordinate validation activities, ensuring timely completion with minimal impact on production schedules.
• Authors validation master plans and ensures compliance with regulatory and industry standards.
• Prepares and reviews final reports, recommending adjustments or corrective actions as needed.
• Supports regulatory compliance by developing and refining validation procedures, recommending policy improvements, and ensuring adherence to FDA, cGMP, GAMP, and EU GMP Annex 11 requirements.
• Engages with external vendors and consultants as needed for validation projects.
• Provides technical training and support to personnel on validation processes and regulatory expectations.
• Performs additional duties as assigned by management, including participation in special projects and continuous improvement initiatives.

Qualifications

• Bachelor’s Degree in Engineering, Microbiology, Sciences, or relevant field of study.
• Minimum of three (3) years validation related work experience.
• Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance.