The Facilities and Validation Technical Manager is responsible for managing the procurement, installation, commissioning, qualification, and use of all BioMARC’s production and analytical equipment. The perfect candidate will have knowledge in managing equipment records and IOP qualifications for manufacturing related equipment in an FDA regulated environment. Requires expertise in project engineering, equipment commissioning and qualification, preventative and corrective maintenance activities, and instrument calibration. The successful candidate will need expertise in GMP (good manufacturing practice) concepts, practices, and procedures. The ideal candidate will also have the ability to proactively manage equipment and facility-related concerns, including being able to make minor mechanical repairs, be able to work in BSL-3, think critically and make professional judgements with regard to personnel management, compliance, quality, and continuous improvement paradigms. Additionally, candidates will ideally be able to clearly and efficiently communicate with others, investigate and report on incidents and provide intelligent corrective proposals, and report job outcomes in a timely manner to Directors and clients.
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