Material Qualification Engineer - #26-25422

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

$71-$86 per hour

Lexington, MA

Contract

Duration: 6 months

Note: This is a Hybrid role with the expectation to be present on-site 3 days a week from Tuesday to Thursday.

Primary Duties

• The individual will be expected to provide material qualification (MQ) support for ***** Massachusetts Biologics Operations (MA Bio Ops) 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.


• Developing MQ validation packages including acquisition of necessary data and summation into final reports.


• Supporting 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


• Providing MQ related technical, compliance and quality support to the TAK-921 Tech transfer team as required.


• Assisting 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.

Job Function and Description

(75% of the time)

• Write, execute, analyze results and summarize MQ activities in the following areas:


• Tech transfer (new product introduction)


• Change management


• Continuous lifecycle management

Develop and assess the following Quality System elements for material qualification:

• Quality Risk Management program


• CAPAs


• Change Controls


• Deviations


• GMP Investigations


• Vendor Change Notifications

Champion site projects involving QC released chemicals and single use raw materials:

• Lead development of technical strategy/philosophy for MQ activities


• Represent MQ during tech transfer activities as required.


• Represent MQ during site GMP activities and participate on cross-functional teams


• Own MQ Quality Systems, as required, and manage project through to closure per timelines

(20 % of the time)

• Identify and deploy opportunities for continuous improvements and adoption of best practices. Represent MA Bio Ops MQ in the global MQ community of practice.

(5% of the time)

• Participate in regulatory agency inspections for MQ.

Education and Experience Requirements

• Essential: 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.


• Desired: Prior experience working in the pharmaceutical or biotech industry, with mAb manufacturing (upstream or downstream) knowledge. Knowledge of single use manufacturing equipment design, and Single use and chemical specification and qualification. Familiarity with major suppliers of materials, standards for material selection and methods for testing the quality attributes as well as leachable and extractables.

Soft Skill and Project Management Requirements

The candidate:

• Will exercise judgment within defined procedures/practices to determine appropriate action.


• Must have the ability to analyze data, quantify risks, and identify gaps independently.


• Must have the ability to propose solutions to problems and elevate issues with proposed solutions to management as necessary.


• The person in this role will be instrumental in working with other members of the Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Manufacturing and Engineering organizations to develop and execute MQ studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals.


• Other departments this person will work closely with include: Process Development, Process Validation, Regulatory Affairs, and Facilities.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement

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