Senior Specialist, Engineering and Validation at Takeda

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Job Description

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.

How you will contribute:

• Ensure equipment are installed, calibrated, qualified, maintained, and decommissioned in compliance with GxP regulations and per internal SOPs

• Schedule and complete equipment preventative maintenance and calibration activities in Blue Mountain Regulatory Asset Management System

• Active, day-to-day liaison between cross functional groups, including Quality Assurance, IT, Facilities, Manufacturing, Quality Control, and outsourced vendors to ensure adherence to quality processes, and compliance standards

• Own and/or author documentation associated with assigned CQV discipline(s); maintain and improve this documentation as necessary to maintain compliance to government regulations, internal corporate requirements, current industry practices, business needs, and current industry best-practices.

• Develop and execute studies, commissioning, and validation protocols. Assist in deviation resolution, summarize results, and author final reports. Plan and manage protocol execution and coordinate with other departments as necessary.

• Responsible for business administration of Asset management and environmental monitoring systems

• Responsible for initiation and completion of Change controls, Deviations, CAPA and lab investigations in Trackwise as applicable.

• May occasionally work in a clean room environment and wear special garments and personal protective equipment) due to safety requirements in specific areas.

• Associate degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 4+ years relevant industry experience

• Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 2+ years relevant industry experience

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

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

• Experience with investigations and deviations in a pharmaceutical manufacturing environment.

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:

U.S. Base Salary Range:

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-termincentives. 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.

LocationsBoston, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt