Validation Manager
Company: Takeda Pharmaceutical
Location: Arcadia
Posted on: May 12, 2022
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Job Description:
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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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