Material Qualification Engineer — Hybrid, Biologics Ops

The Fountain Group; Lexington (MA); Hybrid; USD 69,000 - 118,000; Full time

Benefits offered by this job

Referral Bonus

Job summary

The Fountain Group is seeking a Material Qualification Engineer in Lexington, MA (hybrid) to support Massachusetts Biologics Operations sites in Lexington and Cambridge. The role focuses on developing MQ protocols, reports, and validation packages for single-use components and QC released materials across all manufacturing processes, ensuring patient safety and compliance.

The position offers a 6-month contract with possible extension or conversion, with a hybrid schedule ( onsite Tue-Thu,

Qualifications

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

Responsibilities

• Provide material qualification (MQ) support for company's Massachusetts Biologics Operations site located in Lexington and Cambridge MA, USA.
• 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 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.

Education

Bachelor's in Material Science/Mechanical/Biomedical or Chemical Engineering or related field

Master’s in related field

Job description

The Fountain Group is seeking a Material Qualification Engineer in Lexington, MA (hybrid) to support Massachusetts Biologics Operations sites in Lexington and Cambridge. The role focuses on developing MQ protocols, reports, and validation packages for single-use components and QC released materials across all manufacturing processes, ensuring patient safety and compliance.

The position offers a 6-month contract with possible extension or conversion, with a hybrid schedule ( onsite Tue-Thu,