Job Posting

Sr. Cleaning Validation Engineer II

Lexington, Massachusetts

Apply Now

On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

Small Molecules
Biologics
Plasma
Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0152703 Date posted 05/23/2025 Location Lexington, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Shire Human Genetic Therapies, Inc. for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: Sr. Cleaning Validation Engineer II

POSITION DESCRIPTION: Shire Human Genetic Therapies, Inc. is seeking a Sr. Cleaning Validation Engineer II with the following duties: manage validation programs and projects. Develop validation strategies to test equipment and processes in compliance with domestic and international GMP regulations. Create and maintain validation life cycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrix. Provide technical assessments for Corrective and preventive actions (CAPA’s), deviation, and change control management. Troubleshoot cleaning and steam sterilization issues to ensure smooth manufacturing operation. Collaborate with stakeholders to establish project timelines and scopes. Review and approve validation deliverables including project plans, protocols, reports, risk assessments, and test scripts. Lead continuous improvements into validation activities and policies. Implement best practices for validation programs across facilities. Support new product rollout by validating new systems and processes during Tech Transfer. Represent the organization in contractual or project matters, interacting with senior internal and external personnel. Provide validation expertise to regulatory affairs when responding to governmental regulatory bodies. Up to 5% domestic travel required. Up to 40% remote work allowed.

REQUIREMENTS: Bachelor’s degree in Industrial Chemical Engineering, Chemical Engineering, or related field, plus 7 years of related experience. Prior experience must include: prepare cleaning validation plan aligned with organization policy; prepare cleaning risk assessment for new product introduction or existing product introduced to a new system based on toxicology Data; develop and executed Cleaning Validation (CV) testing Protocols to validate cleaning processes (Clean in Place (CIP), Clean Out of Place (Parts Washers) (COP); develop and execute IQ/OQ/PQ protocols to qualify sterilization systems (autoclaves and Steam in Place SIP) and other GMP equipment.

Full time. $130,800 to $210,600 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0152703. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Apply Now

Working at Takeda

Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient

Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People

Create an exceptional people experience.

Planet

Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.