Biotech Material Qualification Engineer (Single-Use & Raw Materials)

Job Summary Advance your career with a top-tier global pharmaceutical leader in Lexington, MA! We are seeking a skilled Material Qualification Engineer for a dynamic 6-month hybrid role (onsite Tuesday-Thursday). In this high-impact position, you will drive material qualification strategies, support technical transfers, and ensure patient safety across commercial biomanufacturing operations.

location: Lexington, Massachusetts

job type: Contract

salary: $70.00 - 81.38 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Develop and execute Material Qualification (MQ) protocols, reports, and validation packages for single-use components and QC-released raw materials.
• Support the Human Daily Exposure (HDE) program, technical assessments, and Extractables/Leachables (E/L) calculations.
• Manage quality system elements, including Change Controls, Deviations, CAPAs, and Vendor Change Notifications.
• Represent MQ in cross-functional strategy meetings covering Tech Transfer, MSAT, Engineering, and Quality Assurance.
• Lead technical strategies for QC-released chemicals and participate in regulatory agency inspections.

Qualifications

• Bachelor's degree in Material Science, Mechanical, Biomedical, or Chemical Engineering (or related field) with 4+ years of relevant experience, OR a Master's degree with 2+ years of experience.
• Prior experience in the pharmaceutical or biotech industry with mAb manufacturing (upstream or downstream) knowledge.
• Expertise in single-use manufacturing equipment design, single-use specifications, and chemical qualification.
• Strong familiarity with major material suppliers, testing methods for quality attributes, and Extractables/Leachables (E/L) standards.

skills: Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Deviation Investigation, Change Control Management, Quality Control (QC), Technology Transfer

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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