Validation Technician

About the Job

The Validation Technician executes and documents calibration, qualification, and validation activities that support sterile drug manufacturing within a 503B outsourcing facility. This role ensures equipment, utilities, and controlled environments operate in compliance with FDA, cGMP, and data integrity requirements.

Key Responsibilities

• Perform calibration, qualification (IQ/OQ/PQ), and routine requalification of manufacturing equipment, utilities, and critical instruments.
• Execute approved validation protocols and generate compliant final reports.
• Support validation lifecycle activities, including risk assessments and periodic reviews.
• Operate and maintain validation data acquisition systems (e.g., Kaye AVS).
• Document all activities according to ALCOA+ data integrity principles.
• Maintain calibration/validation databases with NIST traceability.
• Cook up and maintain validation data acquisition systems (e.g., Kaye AVS).
• Troubleshoot and perform minor repairs on instruments and equipment.
• Ensure compliance with 21 CFR Parts 210/211 and internal quality systems.
• Support investigations with technical data and root cause analysis.

Basic Qualifications

• AS degree in a technical/engineering/pharma discipline or equivalent experience.
• 24 years experience in pharmaceutical or sterile manufacturing; 503B preferred.
• Knowledge of cGMP, validation principles, cleanroom operations, and aseptic processing.
• Familiarity with USP, ISPE, PDA, and FDA sterile compounding guidance.
• Strong documentation skills in regulated environments.
• Effective communication and ability to collaborate cross-functionally.