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Validation Engineer II

Company: Takeda Pharmaceutical
Location: Marstons Mills
Posted on: September 23, 2022

Job 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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Description -Validation Engineer ITakeda PharmaceuticalCambridge, MAAbout the role:Join Takeda as a Senior Validation Engineer I where you will Develop and assess the following Quality System elements for Validation. You will report to the Validation Engineer Manager.How you will contribute:You will develop and assess the following Quality System elements for Validation:

  • Cold chain, cleaning and steaming / Autoclave and Computer Systems ,Plant Automation
  • Validation Maintenance and document control and archival program
  • Quality Risk Management program
  • CAPAs, Change Controls, Deviations and GMP InvestigationsParticipate and contribute in development, validation strategy, and routine GMP activitiesYou will partner on audits and regulatory agency inspections for Validation.Author and review sections of regulatory filings and product quality reviews.Minimum Requirements/Qualifications:Bachelor's degree engineering or biological sciences and a minimum of 3 years pharmaceutical and/or biopharmaceutical industry experience. - - - - -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
    • Paid time off for vacation, sick leave, and volunteering
    • Community Outreach Programs and company match of charitable contributions
    • Family Planning Support
    • Professional development opportunities
    • Tuition reimbursementImportant ConsiderationsAt Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. You may:
      • Work 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.
      • Work in a cold, wet environment. as well as work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.More About UsAt 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.You will be classified as "hybrid" observing Takeda's Hybrid and Remote Work policy.CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#GMSGQEEO StatementTakeda 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.LocationsUSA - MA - Alewife - BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, New Bedford , Validation Engineer II, Engineering , Marstons Mills, Massachusetts

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