Material Qualification Engineer

Job Description

Job Description

Description:

• The individual will be expected to provide material qualification (MQ) support for 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 product introduction related strategy discussions as required.

• 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.

• 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.

• 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.

Requirements:

• 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.

• 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.

• 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 escalate issues with proposed solutions to management as necessary.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

\nCompany Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities