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Automation Specialist II

2 months ago


Social Circle, Georgia, United States Takeda Pharmaceutical Company Ltd Full time


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Job Overview:


As a key member of the Automation Engineering team, you will play a crucial role in ensuring that the manufacturing equipment and automation systems utilized in the production, storage, testing, and distribution of Takeda products are compliant with Takeda standards and industry regulations.

Your responsibilities will encompass operational, maintenance, and troubleshooting support for site automation systems, including manufacturing and utility equipment such as:

process tanks, Clean in Place (CIP) systems, parts washers, chromatography systems, ultrafiltration units, aseptic filling line equipment, packaging machinery, centrifuges, filter presses, water systems, chillers, and chemical distribution systems.

You will provide support for site automation systems which may include Emerson DeltaV, Honeywell, Siemens, Allen Bradley PLC, OSI-PI plant historian, electronic batch reports, and more.

Your role will involve implementing area and system enhancements through strict adherence to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) in a Pharmaceutical Manufacturing environment.

You will report to the Associate Engineering Director, Automation Manufacturing.

Key Responsibilities:
Complete all aspects of assigned tasks and propose enhancements based on the latest technical insights.

Manage routine small-scale projects and provide hands-on technical support, diagnostics, and troubleshooting for manufacturing operations while guiding design improvements as necessary.

Evaluate existing equipment and control systems in the manufacturing area and identify necessary modifications to meet design, reliability, and operational requirements.

Develop and review automation processes, support equipment and systems, design documentation, and equipment procurement packages. Lead one or more manufacturing process areas, overseeing all investigations and projects within that domain.

Engineer and spearhead improvements in process equipment/control systems reliability, optimization, upgrades, and the implementation of new control systems from concept through to commissioning and validation.

Design and execute modifications to batch-based control systems while adhering to validation and change control protocols; support continuous improvement, process optimization, reliability, expansion, and upgrade initiatives.

Update User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for our equipment and control systems.
Support and train technicians on control system functionality, troubleshooting, and diagnostic techniques.
Develop, revise, and implement procedures for various control systems software configuration, hardware installation, and backup and restoration.

Prepare and review submissions for technical content in accordance with project requirements. Demonstrate a commitment to continuous improvement by enhancing job knowledge and proficiency related to engineering in the biopharmaceutical sector.

Stay updated with assigned SOPs and maintain an up-to-date training file to ensure compliance with all applicable Standard Operating Procedures; communicate with teams and management regarding recommended actions and collaborate in a team-oriented environment.

Be available for shift work to provide issue escalation support.

Qualifications:
A Bachelor's degree in an Engineering discipline is required, along with 2+ years of relevant experience. Proficiency in MS Word, Excel, PowerPoint, and MS Project is essential.

Experience in Distributed Control System implementation, particularly DeltaV, is necessary. Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP is required. Basic knowledge of automation in pharmaceutical or food processing facilities is also necessary.

Basic understanding of instrumentation, Foundation Fieldbus, DeviceNet, and network designs is important.

At Takeda, we are dedicated to delivering quality products that our patients depend on.

As such, we adhere to stringent protocols in our manufacturing facilities to safeguard product quality.


Work Environment:


May require working in a controlled environment necessitating special gowning and protective clothing covering the head, face, hands, feet, and body. This may include additional hearing protection in noisy areas.

All makeup, jewelry, contact lenses, nail polish, and artificial nails must be removed while in the manufacturing environment.

Work may occur in cold, hot, or wet conditions and involve exposure to chemicals such as alcohol, acids, buffers, and Celite, which may require respiratory protection.

Participation in a rotating after-hours process control support function is expected.

More About Us: At Takeda, we are committed to transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs.

Takeda is a patient-focused organization that inspires and empowers you to grow through impactful work.

Recognized as a Global Top Employer, Takeda promotes stimulating careers, encourages innovation, and strives for excellence in all endeavors.

We cultivate an inclusive, collaborative workplace where our teams are united by a steadfast commitment to delivering Better Health and a Brighter Future to individuals worldwide.