This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility:
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
Coordinate external contractors for cleanroom certification
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
Requirements:
AS degree in a technical/engineering/pharma discipline or equivalent experience
2–4 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
What we offer:
competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry