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Job Description

About the role:

The Automation Engineering group ensures that the manufacturing equipment/systems and Automation systems used in the manufacture, storage, testing, and distribution of Takeda products are fit for purpose following Takeda standards and industry regulatory requirements. You will be responsible for operational, maintenance and troubleshooting support for site automation systems including manufacturing and utilities equipment such as: process tanks, Clean in Place (CIP), parts washers, chromatography, ultrafiltration, aseptic fill line equipment, packaging systems, centrifuges, filter presses, water systems, chillers, chemical distribution systems. You will provide support and ownership of the site automation systems which may include Emerson DeltaV, Honeywell, Siemens, Allen Bradley PLC, OSI-PI plant

historian, electronic batch reports, and others. The Engineer will implement area and system improvements through strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility.

How you will contribute:

Responsibilities

• Provide hands-on technical support, diagnostics and troubleshooting functions to manufacturing operations and guide design improvements as applicable.

• Assess existing equipment and control systems in the manufacturing area and determine the required changes to meet the design, reliability and requirements.

• Develop and review the automation of manufacturing process, support equipment and systems, design drawings and documents and equipment procurement packages

• Lead one or more manufacturing process areas, overseeing all investigations and projects in that area.

• Engineer and lead process equipment/control systems reliability improvements, optimization, upgrades and implementation of new equipment control systems from concept to commissioning and validation.

• Design and implement changes to batch based control systems while following validation and change control procedures.

• Support continuous improvement, process optimization, reliability, expansion and upgrade projects.

• Develop User Requirement Specifications, Functional Specifications, Design

• Specifications, and Guidelines for all equipment and control systems.

• Support and train technicians on control system functionality, troubleshooting and diagnostic techniques.

• Implement procedures for multiple control systems software configuration, hardware installation and back up and restoration.

• Develop and review submittals for technical content following project requirements

• Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, and technical

• Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures.

What you bring to Takeda:

Education and Experience Requirements

Bachelor's degree in Engineering discipline required. 2+ years of related experience.

Key Skills, Abilities, and Competencies

• Must have experience in Distributed Control System implementation, especially DeltaV.

• Must have familiarity with industry standards for batch control systems development life cycle methodologies, 21 CFR Part 11, and GAMP.

• Must have basic knowledge in automation of pharmaceutical or food processing facilities.

• Must have basic knowledge in instrumentation, Foundation Fieldbus, DeviceNet and network designs.

Other Job Requirements

The position will require participation in a rotating after-hour process control support function

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 training and 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:

• 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.

• 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.

This posting excludes Colorado applicants.

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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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