Automation Engineer

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Job Description

JOB PURPOSE:

• SME in Manufacturing Control Systems, Operational Technology, Machine Automation and Digitalization
  • Act as system administrator for automation systems.
  • Monitor computerized systems performance to ensure maximum system uptime.
  • Manage system user access, backup and restore.
  • Troubleshooting and implementation of any corrective actions, including working with vendor technical support resources.
  • Support routine system patching programs.
  • Identify, plan and implement small projects to optimize system performance.
  • Participate/lead investigations related to control system deviations.
• Support Site Automation & Digitalization projects – perform project-based tasks, such as:
  • Participate and make suggestions for capital planning, spending and tracking.
  • Participate in project teams representing your responsibilities.
  • Execute/document assigned project tasks within planned schedule and budget, this may include the installation/configuration of systems hardware/software, authoring/updating system documentation.
  • Carry out all assigned responsibilities in compliance with site and corporate Quality Systems.
  • Create engineering deliverables including User Requirements, Functional Design Specifications, Network Architectures, Standard Operating Procedures.
  • Develop test scripts (commissioning/qualification protocols).
  • Participating in developing software lifecycle plans/road maps.
• To develop and implement the Global Automation strategies that will standardize automation group processes and infrastructure.

ACCOUNTABILITIES

• Supports technical availability, operation, optimization, maintenance and life cycle management of buildings, systems, production, and infrastructure equipment assigned to automation department.
• Supports maintaining a complete and accurate documentation for equipment and systems
• Own and develop Automation solutions that are consistent with specific needs of the manufacturing environment.
• Drive the Automation roll-out process at the Site level ensuring cost, schedule and technical solution are achieved.
• Lead and drive Site working groups to ensure clear action plans with delivery milestones for Automation strategies.
• Support harmonization across the network to ensure consistent core solutions are being implemented.
• Be aware of technology trends and benchmarks in the industry. Benchmark against peers so that Takeda is inline with industry.
• Maintain system data integrity compliance to the current Takeda and industry standards

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Must be able to display in-depth knowledge and expertise in Automation solutions including Siemens, Omron, Mitsubishi  (PLC, HMI, SCADA), i-Fix, Wonderware, Inmation (SCADA, Data Management), knowledge of protocols (OPC, Modbus, Ethernet/IP, Profinet, Profibus), SQL databases, scripting language.
• Knowledge of GAMP software development lifecycle, ANSI/ISA-88,95,101,105,106 industry standards, 21 CFR Part 11 and Annex 11.
• Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls
• Displays strong problem-solving capabilities.
• Can display analytical and conceptual thinking.
• Has a deep and broad understanding of pharmaceutical manufacturing process, regulatory environment, trends in automation innovation, and financial acumen.
• Ability to produce technical documentation to a high standard.
• Track record of high performance in relevant reviews.

Interaction

• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
• Is able to easily engage with both internal and external stakeholders to drive performance and rollout Automation solutions.
• Excellent at knowledge sharing through mentoring and training to lift the average expertise level across the site in their area.
• Works with Global Automation to align and implement Automation best practices.
• Independent, self-motivated, organised, and able to multi-task in a manufacturing environment

Innovation

• Is capable of identifying new trends in the industry like cloud computing, IoT, AI, etc.
• Provides inputs for defining the innovation roadmap in GMS Automation strategies.
• Demonstrate ideas for improvements. Contributes to strategic plan for the area.

REQUIREMENTS: 

• Degree in engineering (M. Sc. / B. Sc.) (automation / robotics / computer science or electrical / process / mechanical / chemical or equivalent)
• Experience: min 5 year experience in GMP manufacturing relevant to the specialist area of expertise, including familiarity with principles of data integrity and good documentation practices.

• Broad knowledge of Automation solutions and best practice in field of expertise.
• High communication skills, analytical mind-set, ability to work under pressure.
• GxP/QA knowledge.
• Innovative thinking.
• Building relationships and teamwork.
• Used to working in a complex global / matrix organization.
• Can establish and coordinate service contracts with external service providers.

Additional Desired Skills:

• Experience with data analysis.
• ANSI/ISA-99,100 standards knowledge
• Good understanding of the pharmaceutical industry not limited to technical aspects only.

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