About the Role:
The Computerized Systems Validation Engineering, is responsible for leading, managing, and performing engineering operations within the organization. This role ensures that standards of quality, cost, safety, reliability, timeliness, and performance are met in production processes. By applying advanced knowledge and working independently with limited supervision, this role contributes to the successful completion of engineering projects.
You will support site projects, technical transfers, and ongoing validation maintenance. Responsible for 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
Provides 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 factors or intangible variables
How you will contribute:
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Design, executes, and summarizes commissioning, qualification, and validation studies, collaborating with SMEs to ensure efficient testing strategies.
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Conduct risk and impact assessments, develops, and reviews SOPs, validation assessments, and interfaces with customers on technical issues.
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Participate in audits, inspections, and cross-functional investigations to identify root causes and corrective actions.
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Calculates, interprets data, and supports best practices for validation per industry guidelines.
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Lead small, complex projects with program managers and operations teams.
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Demonstrate continuous improvement in validation expertise within biopharmaceuticals.
What you Bring to Takeda:
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Bachelor’s degree in engineering with minimum 7 years validation experience.
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7 years of relevant experience in a GMP regulated environment.
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At least 4 years of commissioning, qualification and validation (CQV).
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Technical experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP7.
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Knowledge working with Building Automation Systems (BAS) Honeywell
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Knowledge working with Data Historian Systems (DHS) like OSI PI
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Basic knowledge of networks, interfaces, and OPC
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Building practical experience with Systems Engineering, applies basic principles with guidance.
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Building practical experience with algorithms, begins to apply them in simple situations with support.
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Have a basic understanding of systems modeling, apply it with guidance in simple projects.
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Lead validation projects, coordinate contractors, and drive results.
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Direct experience 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. In this role, you may:
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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.
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Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
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Work in a cold, wet environment.
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Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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May be required to work weekends, evenings, off-hours, extended periods of time.
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Occasionally, may be required to lift up to 50 pounds, and be able to walk, stand, reach and stoop.
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Up to 10% travel expected.
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.
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