Associate Director - Validation
Company: Takeda Pharmaceutical
Location: Thousand Oaks
Posted on: March 18, 2023
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information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionJob Title: Associate
Director - ValidationLocation: Thousand Oaks, CAAbout the role:You
will be responsible for oversight of the validation activities
including qualification of equipment, critical systems/utilities,
computerized systems, facilities, cleaning, and sterilization
process qualifications; and ensure continuous state of cGMP
compliance. You will be also responsible for the site Sterilization
and Validation Maintenance programs.How you will contribute:
- Manage validation personnel and projects within boundaries of
quality, time, and budget.
- Approve validation documents and provide general direction to
- Communicate with Engineering, Manufacturing, Regulatory
Affairs, Quality Validation, Quality Operations, Quality Control,
Quality Systems, and other departments.
- Lead team to address commissioning, qualification, and
validation needs of the facility for: Equipment/Facility/Utility
systems, Controls/Automation, Transportation and packaging,
Depyrogenation/Sterilization/Sanitization processes, and Bioprocess
- Process owner for Commissioning/Qualification and Engineering
Change Control, design though qualification.
- Support Global Regulatory Department filings for Thousand Oaks
- Manage regulatory audits for department and coordinate
participation and response.
- Represent Thousand Oaks in the Takeda Engineering Services
community and align local continuous improvement with global
- Administer local application of paperless validation for
Engineering, Manufacturing Sciences, and laboratory method
qualification teams, Kneat.
- Coordinate facility validation strategy with Quality Validation
- Develop business relationships with consultant firms.
- Maintain local compliance with Global Takeda procedures for
Validation maintenance, Engineering records/data archives,
Department metrics and performance reporting.
- Manage overall training, staffing and encourage continuous
improvement by providing guidance and opportunity for team.
- Support manufacturing operation through qualification of
- Maintain the validated state of equipment and support
- Ensure capital project validation requirements are met.
- Ensure a safe working environment and practices.
- Experience with pharmaceutical industry regulations and trends
in the regulatory environment.
- Experience with Commissioning and Qualification processes
consistent with ASTM E2500 requirements.
- In-depth knowledge of GMP and regulations.What you bring to
- Bachelor's degree in engineering or scientific discipline
- 10+ years of experience leading teams in Engineering,
Validation, or related role in Pharmaceutical, Biotechnology or
- Experience in manufacturing processes, control systems,
cleaning processes, process equipment, facilities,
temperature-controlled units, and critical support systems.
- Prior experience working with the FDA and other regulatory
agencies preferred.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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Professional development opportunities
- Tuition reimbursementImportant ConsiderationsAt Takeda, our
patients rely on us to deliver quality products. As a result, we
must follow strict rules in our manufacturing facilities to ensure
we are not endangering the quality of the product. You may:
- Normal office environment, inside working conditions.
- May work in a controlled environment requiring special gowning
and wear protective clothing over the head, face, hands, feet and
body. This may include additional hearing protection for loud
- Will need to remove all make-up, jewelry, contact lenses, nail
polish and artificial fingernails while in the manufacturing
- May work in a cold, hot or wet environment.
- May work around chemicals such as alcohol, acids, buffers and
Celite that may require respiratory protection.
- Work more than 8 hours a day or 40 hours a workweek, including
weekends and holidays.
- May require availability outside of business hours.
- Pace may be fast and job completion demands may be high.More
about us:At Takeda, we are transforming patient care through the
development of novel specialty pharmaceuticals and the best patient
support programs. Takeda is a patient-focused company to 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:
$143,500.00 to $205,000.. 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 and
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off.The final salary offered for this position may take into
account many factors including location, skills, education, and
experience.This posting excludes Colorado applicants.#GMSGQ#ZR1EEO
StatementTakeda 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.LocationsUSA - CA - Thousand Oaks - Rancho ConejoWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Thousand Oaks , Associate Director - Validation, Executive , Thousand Oaks, California
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