Job Description

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Job Description

Validation Manager

Lexington, MA

About the role:

Join Takeda as a 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 develop the validation programs and plans, develop metrics, oversight of base business validation activities and identifying resources to support ongoing operations and facility startup. As part of the Validation, 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 perform 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 status 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 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 prime validation contact for the group
• Work locations in Alewife, North Reading 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.

Base Salary Range: $ 101,500.00 to $ 140,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Student Loan Repayment Program and Paid Volunteer Time Off.

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.

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