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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:
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Manage team to support validation activities. Manage continued development, and retention of the team
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Apply understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training
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Plan, schedule, and lead validation assignments
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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
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Identify gaps related to validation requirements and Global Validation procedures. Guide and close compliance gaps as they are identified
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Review documentation for accuracy and compliance to established procedures with the ability to approve or reject
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Help with regulatory agency inspections, including working with inspectors and corporate/division/internal auditors. Present validation strategy and protocols in regulatory inspections
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Manage other validation personnel, contractors and outside vendors to meet project timelines, goals and milestones
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Monitor and report validation costs including capital and expenses
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Lead in the drafting and implementation of Global Validation procedures including plans for harmonization and streamlining efforts. Develop new validation approaches
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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:
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Bachelors’ degree in Engineering discipline
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6+ years of related experience with 1+ years as a supervisor
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Experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units and critical support systems
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Experience working with the FDA and other regulatory agencies
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Have vast experience, proficiency and leadership in pharmaceutical/biotech validation elements, which includes the writing and performing of protocols and standard operating procedures
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Must be well versed in validation disciplines, Equipment, Facilities, Critical Systems, Utilities, Computer Systems, Process and Materials
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Knowledge of GMPs, FDA and EU guidelines/requirements
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Have advance proficiency in problem analysis and resolution, experience analyzing complex technical problems
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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
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May work in a hot/cold, wet environment and climb up into large processing tanks
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May work in a loud area that requires hearing protection and other protective equipment to be worn
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Can work in confined spaces (e.g. attic space, engine rooms and tanks)
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Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection.
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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:
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Comprehensive Healthcare: Medical, Dental, and Vision
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Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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Health & Wellness programs including onsite flu shots and health screenings
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Paid time off for vacation, sick leave, and volunteering
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Community Outreach Programs and company match of charitable contributions
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Family Planning Support
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Professional development and training opportunities
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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
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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 – CA – Los Angeles
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time