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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Specialist, Cell Therapy Engineering and Validation where you will Support the implementation, qualification, calibrations and maintenance of manufacturing equipment and analytical instruments at Takeda's Cell Therapy Clinical Manufacturing Facility. You will also work with manufacturing operations, quality control, engineering, quality assurance, and IT groups to ensure the facility and all equipment are maintained in a qualified and compliant state.

How you will contribute:

• Develop validation and qualification deliverables such as validation plans, trace matrices, IOQ protocols, user requirements specification, and summary reports.

• Execute qualification protocols for manufacturing equipment, facility, and utilities.

• Manage and supervise vendors for qualification, calibration, and maintenance activities.

• Support equipment implementation projects including scheduling, procurement, site prep, qualification, and release for manufacturing use.

• Provides technical support and guidance on equipment and computer system qualification and validation issues.

• Participates in validation of software systems in collaboration with IT, validation, QA and third-party SMEs.

• Will require occasional weekend work in support of manufacturing operations and work inside a cleanroom manufacturing environment, including gowning-in is required.

• Manage change controls and corrective and preventative actions in quality management system.

Minimum Requirements/Qualifications:

• Associated degree in biotechnology, chemistry, pharmacy, engineering or related pharmaceutical science and 4 years relevant experience in a manufacturing environment or bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 2 years relevant experience in a manufacturing environment.

• Working understanding of cGMP, GXP, GAMP and 21CFR part 11 requirements.

• Experience with validation lifecycle approach (URS, DQ, IQ, OQ, PQ, etc.)

• Understanding of validation practices and processes in a GXP environment

• Familiarity with ISPE, ASTM and other industry commissioning and qualification guidance.

• Understanding of investigations and deviations in a pharmaceutical manufacturing environment. Experience with Trackwise is a plus.

• Strong collaboration skills and ability to lead in cross-functional environment.

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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Cambridge, MA

U.S. Base Salary Range:

$67,900.00 - $106,700.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time