Senior Quality Engineer Bioprocess - (US-MA-Billerica - 01862)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Summary: strives to provide manufacturing bioprocess solutions to the biotech industry. A Millipore solution is a unique, comprehensive, and validated combination of products, services, and applications expertise for and drug product manufacturing.The Senior QE would be responsible for providing QA/RA support to the development of new Millipore products and solutions pertaining to monoclonal antibody processing, cell culture/fermentation/harvesting, chromatography, filtration, disposable processing, PAT, etcΓǪThis position reports to the Manager of Quality Engineering (BioProcess).Primary :Provide expert Quality Assurance and Regulatory Affairs function guidance and support for Millipore product, program, and solution development projects. to include:Product and process validationProduct development and design controlcGMPRisk managementRegulatory assessmentInterface and coordinate activities with other quality functions including manufacturing site quality, quality systems, external quality groups, etcΓǪInterface with and leverage the entire matrix organization at Millipore in order to best achieve organizational goals.Lead and support continuous improvement activities.

Requirements ::7-10 years progressive, seasoned quality and/or validation engineering within the pharmaceutical or biotech industries - bachelor degree in related technical area (engineering, chemistry, microbiology, etcΓǪ)Strong knowledge of domestic and international quality and regulatory requirements, including current industry interpretation.Hands on experience in the application of quality system standardsExperienced at working in cross-functional international teams.Other necessary expertise:Sterile processingContamination controlQuality control and testingFailure analysis and problem solvingContinuous improvementDevelopment of solutions to complex problemsWorking predominantly without direction, exercising considerable latitude in determining objectives and approachesDevelopment, submission, or support of regulatory filingsCompetencies.

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