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Validation Manager

Company: Takeda Pharmaceutical
Location: Arcadia
Posted on: May 12, 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 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.

Job Description
VALIDATION MANAGER

ABOUT THE ROLE:
Join Takeda as a Validation Manager where you will manage a group of validation specialists in the Engineering Validation Department to support Plasma Fractionation and Pharma Purification Manufacturing Activities at the Los Angeles and Van Nuys sites. You will provide expertise and leadership in validation strategy to the site and global projects and have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification, validation, and final report documents. As part of the Validation team, you will report to the Site Engineering Services Lead and work with the manufacturing teams, Engineering, Regulatory, QC, and Quality Operations

HOW YOU'LL MAKE A DIFFERENCE:
Manage team to support validation activities. Manage continued development, and retention of the team

Apply understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training

Plan, schedule, and lead validation assignments

Lead and partner with team members representing the validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning, and validation. Emphasis is on ensuring validation activities meet regulatory guidelines and industry standards

Identify gaps related to validation requirements and Global Validation procedures. Guide and close compliance gaps as they are identified

Review documentation for accuracy and compliance to established procedures with the ability to approve or reject

Help with regulatory agency inspections, including working with inspectors and corporate/division/internal auditors. Present validation strategy and protocols in regulatory inspections

Manage other validation personnel, contractors and outside vendors to meet project timelines, goals and milestones

Monitor and report validation costs including capital and expenses

Lead in the drafting and implementation of Global Validation procedures including plans for harmonization and streamlining efforts. Develop new validation approaches

Provide planning and scheduling support for validation projects. Determine validation scope of work, resources, and duration for projects to meet site-wide validation and budgetary goals

WHAT YOU BRING TO TAKEDA:
Bachelors' degree in Engineering discipline

6+ years of related experience with 1+ years as a supervisor

Experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units and critical support systems

Experience working with the FDA and other regulatory agencies

Have vast experience, proficiency and leadership in pharmaceutical/biotech validation elements, which includes the writing and performing of protocols and standard operating procedures

Must be well versed in validation disciplines, Equipment, Facilities, Critical Systems, Utilities, Computer Systems, Process and Materials

Knowledge of GMPs, FDA and EU guidelines/requirements

Have advance proficiency in problem analysis and resolution, experience analyzing complex technical problems

Will work mostly in an office environment with requirements to work in manufacturing and support areas and in controlled environments requiring special gowning. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn

May work in a hot/cold, wet environment and climb up into large processing tanks

May work in a loud area that requires hearing protection and other protective equipment to be worn

Can work in confined spaces (e.g. attic space, engine rooms and tanks)

Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection.

5% travel to other, Takeda facilities, may be asked of you to manage projects related to these facilities or work with other validation colleagues as part of professional development

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 and training opportunities

Tuition reimbursement

MORE ABOUT US:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and outstanding patient support programs. Takeda is a patient-focused company that inspires and empowers 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 provide Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants
#GMSGQ
#LI-MA1
#ZR1

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 - CA - Los Angeles

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

Keywords: Takeda Pharmaceutical, Arcadia , Validation Manager, Executive , Arcadia, California

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