Associate Director, Validation - Commission & Qualification

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Job Description

Job Title: Associate Director, Validation - Commission & Qualification

Location: Thousand Oaks, CA

About the role:

As the Associate Director, Validation - Commission & Qualification, 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. You will report directly into the Head of Engineering.

How you will contribute:

• Manage validation personnel and projects within boundaries of quality, time, and budget.

• Approve validation documents and provide general direction to technical staff.

• 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 cleaning

• Process owner for Commissioning/Qualification and Engineering Change Control, design though qualification.

• Support Global Regulatory Department filings for Thousand Oaks products

• 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 programs.

• Administer local application of paperless validation for Engineering, Manufacturing Sciences, and laboratory method qualification teams, Kneat.

• Coordinate facility validation strategy with Quality Validation leadership.

• 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 changes.

• Maintain the validated state of equipment and support processes.

• 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 Takeda:

• Bachelor's degree in engineering or scientific discipline required.

• 10+ years of experience leading teams in Engineering, Validation, or related role in Pharmaceutical, Biotechnology or similar organization.

• 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 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

• Professional development opportunities

• Tuition reimbursement

Important Considerations

At 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 areas.

• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.

• 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.

#GMSGQ #ZR1 #LI-1

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 - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time