Validation Manager

Company: Takeda Pharmaceutical
Location: Groton
Posted on: May 12, 2022

Job Description:

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Job Description
Validation Manager

Takeda

Lexington, MA

About 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 change

What 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 occasion

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
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 reimbursement

More 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.

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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.

Locations
USA - MA - Lexington - BIO OPS

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

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