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Job Description

About the role:

Reporting to the Manager, Validation, you will support site projects, technical transfers, and ongoing validation maintenance. You will oversee the design, authorship, and execution of commissioning, qualification and validation studies for the any or more of the following major disciplines:

• 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 different factors or intangible variables.

How you will contribute:

• Independently designs, authors, executes and summarizes commissioning, qualification and 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 validation studies.
• Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.
• 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 for increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding/problem solving capability.
• Lead several small projects with complex features.
• Serve on Tier 1 process teams.

What You Bring to Takeda:

• Bachelor's degree in Engineering discipline preferred.
• Minimum 5 years validation experience for this non-manager role
• Minimum 7 years of relevant experience in a GMP regulated environment.
• At least 4 years of commissioning, qualification and validation (CQV) desired.
• Work within a team environment, working with individuals at all levels in an organization and departmental areas.
• Be flexible to changes in approach in dynamic work environments.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
• Proficient with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
• Validation and 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 blood.
• Technical experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
• Lead validation projects, coordinate contractors, and achieve results.
• Direct experience within manufacturing operations and biotechnology processes is desired.

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:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• May work weekends, evenings, off-hours, extended periods of time.
• Occasionally, may lift up to 50 pounds, and be able to walk, stand, reach and stoop.
• Need to gown and operate in an environment requiring gowning.
• Up to 10% travel expected.
• Need to remove all make-up, jewelry, contact lenses, nail polish and 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.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

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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