Associate Engineer
Insight Global
A leading pharmaceutical manufacturer is seeking an Associate Engineer to join its Commissioning & Qualification (C&Q) team. This individual will support qualification, validation, and compliance activities for Controlled Temperature Units (CTUs) and other GMP-regulated equipment. The role involves executing qualification protocols, conducting thermal mapping studies, supporting deviation investigations, and maintaining GMP documentation to ensure regulatory compliance. Key Responsibilities Execute IQ, OQ, and PQ protocols for CTUs and GMP equipment. Support equipment qualification, requalification, and validation activities. Conduct thermal mapping studies using Kaye Validator AVS. Investigate deviations and assist with CAPA activities. Maintain qualification packages, calibration records, validation reports, and GMP documentation. Ensure compliance with GMP requirements, site procedures, and quality standards. Collaborate with Engineering, Quality, and Manufacturing teams on validation projects. Required Skills Bachelor's Degree in Engineering. 1-2 years of experience in a GMP-regulated environment. Experience with GMP documentation and compliance practices. Strong organizational and technical writing skills. Comfortable working on-site five days per week. Plusses CTU (Controlled Temperature Unit) experience. Thermal mapping experience. Experience with Kaye Validator AVS. Exposure to deviation investigations and CAPA processes. #J-18808-Ljbffr
Vacancy posted 1 day ago
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