Hybrid MQ Engineer — Pharma/Biotech

Us Tech Solutions; Lexington (MA); Hybrid; USD 98,000 - 118,000; Full time

Job summary

Us Tech Solutions in Lexington, MA seeks an MQ Specialist to support material qualification at MA Bio Ops sites in Lexington and Cambridge. The contract role focuses on developing MQ protocols, validation packages and cross-functional technical support for process changes and technology transfers.

The candidate will work in a hybrid setting, onsite 3 days a week, Tuesday to Thursday, for a 6-month duration, supporting QA/Compliance and site operations in a fast-paced biotech environment.

Qualifications

• Essential: 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

• Develop MQ protocols, reports and documentation for single use components and QC released raw materials across manufacturing processes.
• Develop MQ validation packages including data acquisition and final reports.
• Support the HDE program including technical assessments and E/L calculations to ensure patient safety for DS manufactured at MA Bio Ops.
• Provide MQ related technical, compliance and quality support to TAK-921 Tech transfer team as required.
• Assist with change controls, deviations and investigations; assess proposed changes to maintain validated status.
• Represent MQ in meetings with operations, engineering, quality, MSAT and new product introduction strategy discussions.

Education

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

Master’s in related field

Tools

Single-use manufacturing equipment

Job description

Us Tech Solutions in Lexington, MA seeks an MQ Specialist to support material qualification at MA Bio Ops sites in Lexington and Cambridge. The contract role focuses on developing MQ protocols, validation packages and cross-functional technical support for process changes and technology transfers.

The candidate will work in a hybrid setting, onsite 3 days a week, Tuesday to Thursday, for a 6-month duration, supporting QA/Compliance and site operations in a fast-paced biotech environment.