Validation Manager

Company: Takeda Pharmaceutical
Location: Groton
Posted on: May 10, 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 DescriptionValidation ManagerTakedaLexington, MAAbout the role:Join Takeda as a CSV and AIQ Validation Manager where you will support Validation activities and will be an essential on the design, startup, validation and ongoing operations of sites. You will also maintain the computer system validation programs and plans, develop metrics, oversight of base business validation activities and identify resources to support ongoing operations and facility startup. As part of the Validation group, you will report to the Head of Validation and work with several team members and groups within the facility.How you will contribute:

• You will manage and the development of validation protocols, the development of validation studies, data analysis, and compilation of the data and results into final reports
• You will participate and contribute in design development, commissioning planning, and turnover of systems
• You will manage a team of validation professionals to support start up, validation, on ongoing operations of the Technical Operations Center
• You will develop master plans and execution plans for validation projects
• You will review proposed changes to validated systems and identify the validation requirements necessary to maintain the system's validation state after execution of the changeWhat you bring to Takeda:
  • Bachelor's degree (in Life Science, Biotechnology, Engineering is a bonus) with 6 years experience in validation or a Master's degree with 5 years experience in validation
  • Experience with Kneat software
  • Experience with Computer Systems Validation and System/software Development Lifecycle
  • Experience with FDA and foreign (European and Canadian) validation requirements and expectations
  • Experience working with wide range of complex problems, which require the regular use of creativity
  • Experience working with senior management and outside senior professionals while being primary validation contact for the group re3garding CSV and AIQ
  • Work locations in Alewife, North Reading, Lexington, and Cambridge MA on occasionWhat 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
    • Generous time off for vacation and the option to purchase additional vacation days
    • Community Outreach Programs and company match of charitable contributions
    • Family Planning Support
    • Flexible Work Paths
    • Tuition reimbursementMore 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.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#GMSGQ#ZR1#LI-MA1EEO 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 - Lexington - BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Newton , Validation Manager, Executive , Groton, Massachusetts