Associate Engineer
Insight Global
Associate EngineerInsight Global is looking for an Associate Engineer to support one of their largest pharmaceutical clients within their C&Q department. This individual is responsible for supporting qualification, validation, and compliance activities for Controlled Temperature Units (CTUs) and other GMP-regulated equipment. This role will lead requalification efforts, thermal mapping studies, protocol execution, deviation investigations, and documentation activities to ensure compliance with regulatory requirements, internal quality standards, and site procedures. The position requires willingness to gain technical expertise in commissioning, qualification, validation (CQV), data integrity, and GMP documentation practices. Develop, execute, and document equipment qualification protocols in accordance with approved SOPs and validation plans. Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Maintain qualification packages, calibration records, validation reports, audit trails, and supporting documentation. Conduct thermal validation studies utilizing the Kaye Validator AVS system.
Vacancy posted 2 days ago
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