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Principal Project Engineer - Reagent Chemist

Company: Joule
Location: Brookline
Posted on: June 17, 2022

Job Description:

Title: Principal Project Engineer- Reagent Chemist Location: Boston, MA Schedule: Mon-Fri 8AM-5PM Type: Direct Hire Start date: ASAP Responsibilities:3 main responsibilities for this role. Tech contributor to chemical reagent strategy; working closely with supply chain and where the materials are acquired from, Bridging new reagents into production; working closely with scientific group as they develop new reagents helping from scale to a manufacturing level, Developing out biologics materials; for the tank system will work with external vendors to bring it to commercial levelWorking together with the operations and supply chain organizations, this role will have technical ownership of our overall reagent and chemical supply strategy. This will include assessment of vendors and the development and execution of qualification strategiesContribute to the development of novel reagents and ensure they are ready for transfer to manufacturing processesLead the development of biologic control systems for use in in-vitro diagnosticsProvides technical support to manufacturing and quality organizations to aid in the troubleshooting of reagent based non-conformities and corrective actionsDemonstrates deep/advanced knowledge of specialized discipline and methods, and applicability to specialized product needs to support customer, operational policies and processes. Interfaces with customers, suppliers, application users, and other technical and support personnel as necessaryDevelops complex test protocols; reviews, and rejects or approves test protocols developed by others, documents/reports findings, and provides corrective guidance Requirements:BS in a relevant Engineering discipline such as Biomedical, Chemical, Mechanical or equivalent required10 years hands-on technical experience developing complex / multidisciplinary reagent systems for in-vitro diagnostics required10 years experience with medical device / IVD development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems required5 years experience with hemostasis based diagnostic and reagent systems preferred3 years proven technical leadership over the development of a complex / multi-disciplinary product in a regulated environment required Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: Joule, Brookline , Principal Project Engineer - Reagent Chemist, Engineering , Brookline, Massachusetts

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