What are the responsibilities and job description for the Materials Engineer position at The Fountain Group?
The Fountain Group is currently seeking a Material Qualification Engineer for a prominent pharmaceutical client of ours. This position is located in Lexington, MA (hybrid).
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 product 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.
Salary : $50 - $86