Material Qualification Engineer

The Fountain Group is currently seeking a ­­­­­­­­Material Qualification Engineer for a prominent client of ours. This position is located in ­­Lexington, MA (hybrid). Details for the position are as follows:

Pay Range: $50 - 86/hr depending on experience/education
Contract: 6 months with possible extension and/or conversion
Hybrid role: Tuesday - Thursday onsite / Monday & Friday remote

Job Description:

• Provide material qualification (MQ) support for company's Massachusetts Biologics Operations site located in Lexington and Cambridge MA, USA.
• The MQ activities related to the Lexington & Cambridge manufacturing site include, but are not limited to, the following areas:
• Development of MQ protocols, reports and other documentation for single use components and QC released raw materials within all manufacturing processes.
• Develop MQ validation packages including acquisition of necessary data and summation into final reports.
• Support the Human Daily Exposure (HDE) program including technical assessments and Extractables/Leachables (E/L) calculations to ensure patient safety related to commercial Drug Substance (DS) Manufactured at MA Bio Ops Provide MQ related technical, compliance and quality support to the TAK-921 Tech transfer team as required.
• Assist technical assessments on change controls, deviations and investigations, assessing proposed changes to validated process components to identify requirements necessary to maintain validated status.
• Represent MQ in meetings and participating in operations, engineering, quality, MSAT and new prodict introduction related strategy discussions as required.
• Interface with other site functions including procurement, quality, manufacturing, engineering, compliance and process development to effectively communicate requirements for material qualification and ensure they are a part of routine site business processes.

Qualifications:

• Bachelor's in Material Science, Mechanical, Biomedical or Chemical Engineering or related science or engineering field with a minimum of 4 years relevant experience or Master’s in related field with a minimum of 2 years relevant experience.

If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at olivia.larkin@thefountaingroup.com.

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