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Takeda Pharmaceuticals Validation Engineer II in Lexington, Massachusetts

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Job Description

Job Title: Validation Engineer II

Location: Lexington, MA (USA)

About the role:

As a Validation Engineer II, you will provide support to the validation strategy for the site and global projects team members. You will be responsible for qualifying equipment, critical systems (utilities), facilities, computerized manufacturing systems, cleaning processes, and sterilization processes, as applicable.

You will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis.

This is a hybrid role that reports to the Engineering Services Lead. Weekend and evening work may be required.

How you will contribute:

  • Development of protocols, coordination of initial and revalidation activities, qualification/validation execution, preparing final reports and assembly of final validation packages for requalification activities (annual validation maintenance plan). Re-qualification activities include CIP/COP, chambers, SIPs, Autoclaves, and documentation activities for periodic review.

  • Apply thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training to support manufacturing and engineering.

  • Participate and work with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning, and validation. Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards.

  • Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, etc.).

  • Use Quality-Engineering tools to problem solve/troubleshoot and help with risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC).

  • Identify gaps related to validation requirements and Global Validation procedures. May assist in closing compliance gaps as they are identified.

  • Perform update to validation plans and use validation test equipment, such as Ellabs loggers to support validation activities.

  • Participate in the investigation and closure of non-conformances/events, corrective actions and preventative actions.

  • Support internal or external assessments or audits. Support process with timely closure of observations/audit items.

  • Perform other duties as directed by supervisor.

Minimum Requirements/Qualifications:

  • Minimum BS or BA, preferably in Engineering or Science 4 or more years of experience in biopharmaceutical manufacturing environment validation, operations, engineering, or any combination thereof.

  • Experience in manufacturing processes and control systems (e.g., Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process materials, process equipment, facilities, and critical support systems (utilities) are required, as applicable.

  • Experience with KNEAT.

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.

  • Will work mostly in office environment with requirements to work in manufacturing and support areas.

  • Will work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

  • May work in a hot/cold, wet environment and climb up into large processing tanks.

  • Will work in Cleanrooms, including cold/hot storage conditions.

  • May work in a loud area that requires hearing protection and other protective equipment to be worn.

  • Must have the ability to work in confined spaces (e.g., attic space, engine rooms and tanks).

  • Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection.

  • 5% travel may be required to other Shire facilities in order to manage projects related to these facilities or interact with other validation colleagues and/or as part of professional development.

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.

#GMSGQ #ZR1 #LI-MA1 #LI-Hybrid

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.


USA - MA - Lexington - BIO OPS

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Full time