Senior Validation Engineer

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On the Global Manufacturing and Supply (GMS) team at Takeda, you'll be part of a rapidly transforming industry that's applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

• Small Molecules
• Biologics
• Plasma
• Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0122673 Date posted 05/13/2024 Location Social Circle, Georgia

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About the role:

Join Takeda as a Senior Validation Engineer where you will support site projects, technical transfers, and ongoing validation maintenance. You will focus on the design, authorship, and execution of commissioning, qualification and validation studies for the following major disciplines and report to the Engineering Validation Manager at our location in Social Circle, GA.

• 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

You will provide technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. You must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of multiple 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.
• Communicate 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.
• 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.

What You Bring to Takeda:

• Bachelor's degree in Engineering discipline required. Minimum 7 years validation experience for non-manager role; 5+ years experience for Supervisor.
• 7 years of relevant experience in a GMP regulated environment.
• At least 4 years of commissioning, qualification and validation (CQV).
• 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 with automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
• Lead validation projects, coordinate contractors, and achieve results.
• Direct manufacturing operations experience and biotechnology processes
• Must 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.
• Excellent analytical skills with systematic approaches to solving problems. 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.

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 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.
• 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 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.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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