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Design Quality Engineer- Biotechnology

Company: Michael Page
Location: Marlborough
Posted on: January 15, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryProvide Process/Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. Provide direction in the areas of Design Controls & Risk Management to cross-functional teams.Client DetailsOur client is a bioprocessing-focused life sciences company bringing over 30 years of expertise and innovation to customers that aid in development and commercialization of products and solutions that address steps in the production of biologic drugs and principally monoclonal antibodies.Description* Serves as Subject Matter Expert for application of Design Controls in accordance to regulatory expectations (e.g., Quality System Regulation, ISO standards, ASME BPE, etc.). Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. * Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. * Ensure the development and validation of appropriate test methods for product and process performance * Ensure active and thorough investigation of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints)..* Support the suATF product line through the review of batch records and lot release.* Additional responsibilities involve review of supporting data for production activities, such as, environmental monitoring, Reverse Osmosis Deionized water, cleaning logs, and controlled temperature chamber logs. This individual will also assume various administrative functions, such as, label generation, binding, and filing of production records Profile* At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred).* Understanding of basic chromatography, fermentation and purification (production and lab scale) is required for this position* Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred* Minimum 5-7 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalentJob Offer* Competitive base salary at global company with growth similar to a start upSDL2017

Keywords: Michael Page, Boston , Design Quality Engineer- Biotechnology, Engineering , Marlborough, Massachusetts

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