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Job Description
JOB PURPOSE:
* SME in Manufacturing Control Systems, Operational Technology, Machine Automation and Digitalization
o Act as system administrator for automation systems.
o Monitor computerized systems performance to ensure maximum system uptime.
o Manage system user access, backup and restore.
o Troubleshooting and implementation of any corrective actions, including working with vendor technical support resources.
o Support routine system patching programs.
o Identify, plan and implement small projects to optimize system performance.
o Participate/lead investigations related to control system deviations.
* Support Site Automation & Digitalization projects – perform project-based tasks, such as:
o Participate and make suggestions for capital planning, spending and tracking.
o Participate in project teams representing your responsibilities.
o Execute/document assigned project tasks within planned schedule and budget, this may include the installation/configuration of systems hardware/software, authoring/updating system documentation.
o Carry out all assigned responsibilities in compliance with site and corporate Quality Systems.
o Create engineering deliverables including User Requirements, Functional Design Specifications, Network Architectures, Standard Operating Procedures.
o Develop test scripts (commissioning/qualification protocols).
o 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.
Locations
Bray, Ireland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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