{"id":1283310,"url":"https://alion.io/job/takeda-pharmaceutical-quality-assurance-validation-associate","title":"Quality Assurance Validation Associate","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":85,"open_postings":26,"ghost_share":0,"stale_share":0.615,"repost_share":0,"time_to_fill_p50_days":22,"computed_at":"2026-10-02T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Thousand Oaks, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":71800,"max":112860,"currency":"USD","period":"year","gross":null,"usd_annual":112860},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-25T00:00:00Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-02T23:55:02Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"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’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description\nAbout the role:\nAs a Quality Assurance Validation Associate, you will work as part of cross-functional teams providing quality oversight, review, and approval of validation deliverables and change controls to ensure that products and processes meet appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position will typically focus on disciplines related to facilities, utilities, equipment, process qualification, cleaning, QC methods and instruments, computer systems validation and data integrity.\nHow you will contribute:\nResponsible for reviewing validation documents, against Standard Operating Procedures (SOPs) for accuracy and compliance with procedures, based on regulatory requirements and internal guidelines.\nReview from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.\nResponsible for reviewing Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages in accordance with existing procedures. Reviews deliverables for compliance with existing requirements. Approves documentation related to system decommissioning.\nProvide validation expertise and support for the development (or modification phases) of manufacturing facility, utilities, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.\nParticipate in the risk assessment related to the project.\nAssure requirements traceability throughout the whole project life cycle.\nProvide support in all quality-related issues, including GMP regulations\nAssess and approve Change controls, CAPAs and deviations to ensure conformance to regulatory agency requirements, company standards and industry best practices\nTake part in internal/external audits.\nMaintain project metrics to communicate risk trends and implementation readiness to support project timelines and commercial readiness\nMay perform other duties as assigned.\nWhat you bring to Takeda:\nBachelor’s Degree in Biotechnology, Microbiology, Pharmacy or equivalent is strongly preferred.\nMinimum of 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.\nExperience in pharmaceutical/biotech validation which includes the writing and executing of protocols.\nProficiency in electronic document management systems (e.g. Veeva, Kneat, ALM)\nStrong knowledge of US GMP/EU regulations and GxP guidelines.\nExtensive cross-functional team experience, including technical and non-technical work.\nImportant Considerations:\nAt 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. In this role, you may:\nWork in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.\nNeed to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.\nWork in a cold, wet environment.\nWork multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.\nWork around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.\nIn general, position requires both sedentary work and walking through facility\nWrist and hand motion (typing, writing)\nMust be able to occasionally visit controlled or clean room environments requiring gowning. May be required to wear personal protective equipment (PPE) and other clean room garments daily (may include safety shoes, safety glasses, lab coats, full body gowns, goggles, hair covers, and gloves. No make-up, jewelry, contact lenses, nail polish, or artificial nails may be worn in these environments.\nAlthough assignments will be made specific to working hours, flexibility is expected, with the understanding that there may be changes in work hours, duties, and responsibilities.\nMore about us:\nAt 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.\nCertified 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.\n#GMSGQ #ZR1 #LI-MA1\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nUSA - CA - Thousand Oaks - Rancho ConejoU.S. Base Salary Range:\n$71,800.00 - $112,860.00The 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.\nFor information about our benefits, please click here.\nEEO Statement\nTakeda 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.\nLocations\nUSA - CA - Thousand Oaks - Rancho ConejoWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull timeJob Exempt\nYes","description_format":"text","description_chars":6922,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-26T03:46:53Z"}],"liveness":{"score":59,"band":"ok","label":"Likely open","p_open":1,"p_active":0.589,"p_room":1,"age_days":7,"expected_fill_days":22,"reasons":["conf:7","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-02T05:45:00Z"},"pay":{"stated_usd_annual":112860,"is_top_pay":false},"html_url":"https://alion.io/job/takeda-pharmaceutical-quality-assurance-validation-associate","json_url":"https://alion.io/job/takeda-pharmaceutical-quality-assurance-validation-associate.json","meta":{"generated_at":"2026-10-03T01:39:37Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1653,"day_limit":5000,"remaining_today":3347,"minute_limit":60,"resets_at":"2026-10-04T00:00:00Z"}}}