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Job Description

About the role:

Join Takeda as a validation engineer where you will support site projects, technical transfers, and ongoing validation maintenance. You will be responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies and report to the Engineering Validation Manager.

How you will contribute:

• Facilities, Utilities, and Equipment (FUE) qualification
• Units operations automation qualification with Honeywell, Delta V, and PCL-based systems
• Computerized systems validation
• Cleaning validation
• Sterilization validation
• Materials validation
• Process validation
• Provide technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. Individual must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of multiple factors or intangible variables.

What you bring to Takeda:

Responsibilities:

• Independently designs, authors, executes and summarizes commissioning, qualification and/or validation studies. Partner with SMEs to ensure efficient execution of testing strategies.
• Collaboratively conduct risk and impact assessments.
• Support development of standard operating procedures (SOP) and validation assessments.
• Work with customers on technical issues, project timelines and validation support.
• Participate on teams to determine the root-cause and corrective actions for problems associated with investigations.
• Calculation and interpretation of data for commissioning, qualification and/or validation studies.
• Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team.
• Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
• Support operations and communications with Program Managers.
• Exercise judgment within defined policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.
• Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding capability.
• Lead several small projects with complex features.
• Serve on Tier 1 process teams.

Education and Experience Requirements:

• Bachelor's degree in Engineering discipline preferred.
• Minimum 5 years validation experience for non-manager role
• 7 years of relevant experience in a GMP regulated environment.
• At least 4 years of commissioning, qualification and validation (CQV) desired.

Key Skills, Abilities, and Competencies

• Work in a team environment, working with individuals at all levels in an organization and departmental areas.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
• Proficiency with Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
• Validation and/or system experience in the following applicable areas:
• Sterilization and aseptic processing validation.
• Cleaning validation of manufacturing equipment.
• Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
• Protein purification from mammalian plasma and/or blood.
• Technical experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
• Lead validation projects, coordinate contractors, and achieve results.
• Direct manufacturing operations and biotechnology process experience is desired.

Complexity and Problem Solving:

• Excellent analytical skills with systematic approaches to problem solving. Can break down complex problems and tasks into manageable activities.
• Must have basic knowledge of core principles in validation disciplines, and be experienced applying project management methodology.
• Knowledge of basic principles in multiple engineering disciplines.

Internal and External Contacts:

• Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation to support execution activities.
• Interaction with project managers for schedule adherence.

Other Job Requirements:

May work weekends, evenings, off-hours, extended periods of time.

• Occasionally, may lift up to 50 pounds.
• Need to gown and operate in an environment requiring gowning.
• Up to 10% travel expected.

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 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

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More About Us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will 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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

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