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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.
Bray, Ireland
Employee
Regular
Full time
