Job Description

About the role:

You will work as part of cross-functional teams providing quality oversight and approval of change control and validation deliverables to ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. This employee will typically focus on disciplines related to equipment, cleaning, process, control system, analytical instruments, and computer system validations.

How you will contribute:

• Owns Standard Operating Procedures and other Quality System Documentation relevant to their area of expertise.

• Approve Standard Operating Procedures and other Quality System Documentation important to all areas of the plant.

• Develop and deliver training materials relevant to area of expertise. Approve training materials important to all areas of the plant.

• Participate as a team member in the execution and documentation of Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, Validation Maintenance packages, Computerized System Change Orders, Controlled System Work Requests following existing procedures. Review deliverables for compliance to defined requirements. Approve validation documentation (e.g., protocols, CWRs, or risk assessments) that establishes novel requirements or assesses risk.

• Lead cross-functional teams in the execution of risk management activities.

• Manage investigations and CAPAs important to responsibilities/expertise. Approve investigations and CAPAs important to all areas of the plant.

• Approve change controls for compliance to existing requirements.

• Lead Quality project teams and presents Plant management project plans, progress, and risks.

• Represent us in areas of expertise to governmental Regulatory bodies.

• Must be proficient in written and oral English.

• Experience validation of equipment, facilities, utilities, and analytical instruments.

• Knowledge of change control process using Trackwise

• Experience applying cGMPs. Knowledge of validation principles across multiple disciplines.

• Excellent stakeholder management skills to manage all partners that support the site.

• Excellent influencing/collaboration skills and teamwork mindset.

• Experience presenting to inspection auditors.

• Knowledge of descriptive statistics. Working knowledge of inferential statistics and related techniques (e.g., sample size determination, comparison analysis, ANOVA, DoE).

• Identify, escalate, and resolve potential compliance and safety issues.

What you bring to Takeda:

• Typically requires bachelor’s degree in science, engineering or other related technical field.

• 4+ years of related experience.

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:

• Indoor working conditions

• Will work around moving equipment and machinery.

• You will be asked to not be allergic to Cephalosporin drugs.

• 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.

• Will work nights, weekends, and holidays to support manufacturing when needed.

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.

This posting excludes Colorado applicants.

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: 80,000 - 100,000.

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