Job Description

About the role:

As a Senior Engineer II, you will provide material science, material qualification (MQ) and routine GMP manufacturing support for Takeda Massachusetts Biologics Operations (MA Bio Ops) site located in Lexington and Cambridge MA, USA. You will will be the subject matter expert for single-use technologies and raw materials within depth knowledge of industry best practices and regulatory guidelines. You will report to Head of Material Qualification.

How you will contribute:

Support resolving complex problems and lead single use and raw material process standardization, strategy sourcing, and control strategy in collaboration with cross-functional teams.

Lead the assessment of new materials, and implement best practices across multiple programs, including phase appropriate program and control strategy based on scientific and risk principles.

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.

Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated process components to identify requirements necessary to maintain validated status.

Oversee materials related quality systems (CAPA, Change Control) and use project management skills to independently lead project teams.

Represent materials science and qualification on project primary teams and participate in strategy discussions in collaboration with Manufacturing Sciences team and aligned with regulatory requirements.

Support strategy development for tech transfers and new product introductions for qualifying new chemical and single use raw materials.

Communicate with other site functions including procurement and process development to communicate requirements for material qualification and ensure they are a part of routine site business processes.

Partner with manufacturing, supply chain, and quality teams to address material improvements and alternate sourcing opportunities.

Author material sections of regulatory filings and help review the CMC part of regulatory submissions and authority requests.

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

Develop and assess the following Quality System elements for material qualification including Quality Risk Management program, CAPAs, Change Controls, Deviations, GMP Investigations, Vendor Change Notifications, Represent MQ during site GMP activities and quantifying risks, and identify gaps independently.

Write, complete, analyze results and summarize materials science and qualification activities including tech transfer (new product introduction), change management and continuous lifecycle management

What you bring to Takeda:

Bachelor's in Material Science, Mechanical or Chemical Engineering or related science or engineering field with 8 years relevant experience or Master's in related field with 6 years relevant experience.

Prior experience with single use manufacturing equipment design, specification and qualification.

Can lead departmental programs and small project teams.

Familiar with major suppliers of single use systems, standards for material selection and methods for testing the quality attributes and leachable and extractables.

Can work at all MA site locations as required.  The person in this role will be required to carry a cellular phone and be on call as required to support material qualification activities

What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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