Hiring company: Takeda
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a TTechnician/Validation Specialist - Cell Therapies in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
POSITION OBJECTIVES:
This role will support the implementation, qualification and maintenance of manufacturing equipment, analytical instruments and utilities at Takeda’s Cell Therapy Manufacturing Facility. The position will work with manufacturing operations, quality control, engineering and IT groups to ensure the facility and all equipment are maintained in a qualified and compliant state.
ACCOUNTABILITIES:
Develop validation and qualification deliverables such as validation plans, IOQ protocols, User Requirements Specifications and summary reports
Execute qualification protocols for manufacturing equipment, analytical instruments, facility and utilities
Temperature mapping of Controlled Temperature Units using wired or wireless mapping systems
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 systems qualification and validation issues
Participate in validation of software systems in collaboration with IT, validation, QA and third-party SME’s
Will require occasional weekend work in support of manufacturing operations and work inside a cleanroom manufacturing environment, including gowning is required
Perform other tasks as assigned
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
For Technician: Associates degree in biotechnology, chemistry, pharmacy, engineering or related pharmaceutical science and 2 years relevant experience in a manufacturing environment or Bachelor’s degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science
For Specialist: Associates 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.)
Familiarity with ISPE, ASTM and other industry commissioning and qualification guidance
Experience using Kaye Validator and CTU temperature mapping is strongly preferred
Understanding of investigations and deviations in a pharmaceutical manufacturing environment
Proficient with Microsoft Office including Word, Excel and PowerPoint
Knowledge and Skills:
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
Teamwork – Ability to work well in a fast-paced multi-disciplinary environment
Communication - Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor
Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
Motivated – Self-motivated and willing to accept temporary responsibilities outside of initial job description
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
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This job posting excludes CO applicants.
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.