
Head of Automation, Engineering (Hikari Plant)
- GMP
- Network Security
Not enough detail in this posting to match
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Job Description
OBJECTIVES/PURPOSE
- Lead the implementation of both global and local automation strategies, overseeing the design, deployment, commissioning, and maintenance of automation systems.
- Serve as the SME under the Head of Engineering for the Hikari Plant, managing the automation group and driving the automation of production and utility facilities, while providing specialized expertise and governance in digital and automation activities.
- Collaborate closely with the manufacturing teams to ensure all digital and automation initiatives support reliable, compliant, and robust ongoing manufacturing operations.
- Build and maintain a team structure within the automation group composed of personnel with appropriate skills and capabilities to achieve company-wide engineering department objectives.
- Provide continuous and sufficient technical support to the automation group to drive engineering improvement initiatives and maximize results
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ACCOUNTABILITIES
- Lead, resource as appropriate and manage the portfolio of Digital/Automation engineering works.
- Provide the necessary leadership to drive and maintain the engineering operations and technical support for Automation Group as appropriate.
- Provide the necessary technical engineering support to ensure that all manufacturing facilities are available and fit for intended purposes.
- Fully accountable for all automation functionalities with respect to assetsâ performance, reliability, safety and compliance.
- Partner with other functions to provide the necessary technical support and Engineering expertise with respect to Process and infrastructure equipment including the overall Automation infrastructure. This includes system owner support to maintain the required URS, specifications and standards to ensure the ongoing reliability of installed Automation assets at the site.
- Hire and train the workforce as necessary for the site Automation engineering function.Â
- Develop the Automation Group to make sure that all reports can fulfill their assigned functional goals and KPIs and contribute to the achievement of the overall Site Engineering Department goals and KPIs.
- Own all the associated and assigned systems safety, compliance and Automation performance.
- Manage out of hours emergency / urgent response from Automation Group.
- Support process system owners and CAPEX team in the specification, operation of key assets via applying best digital/automation practices.
- Execute selection and manage service contractors and suppliers ensure right services, competency level, cost and fulfilment to relevant Quality, EHS, Finance, regulatory policy and requirement.
- Develop and maintain SOPs for automation systems fulfilling Regulatory Requirements and EHS Policies.
- Provide technical expertise to enable rapid trouble shooting and in-depth investigations relating to failure and mal operation to maintain and improve asset availability and reliability.
- Provide the necessary technical expertise to ensure that all engineering master data for automation systems is identified and maintained in an appropriate and compliant fashion.Â
- Create and maintain appropriate training standards, guides and material for Automation engineering.
- Manage assigned projects within the engineering function and support other departments at site in the planning and execution of projects.
- Consult and coordinate with Global Engineering to share lessons learned and best practices.
- Liaise with Global Engineering and Global DD&T to provide feedback on proposed and existing engineering standards and implement these as appropriate within the facility.
- Carry out any other duties assigned by supervisor.
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DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Wide range of knowledge and experiences of engineering project management, digital, automation and IT technology.
- Have basic engineering knowledge of electrical, digital, automation, IT and so on.
- Have basic knowledge of pharmaceutical production processes like API, solid dosage, sterile manufacturing/ filling, biologics, vaccine, inspection and packaging.Â
- Understand GMP requirements (local and global) Â especially computerized system validation and ALCOA concept.
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- GMPãç¹ã«CSVãšALCOAã«é¢ããèŠèã
Leadership
- Transform the traditional approach to the best.
- Provide the technical resolution to plant manufacturing problems on a timely basis and with appropriate urgency.
- Work with global engineering and global DD&T to drive a digital innovation.
- Demonstrate leadership mindset and behavior to Automation engineer.
- Develop and maintain automation engineers to maintain/improve automated systems.
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Decision-making and Autonomy
- Identify opportunities for departmental performance improvement, develop alternative solutions to potential problem areas and establish necessary contingency plans.
- Present ideas with clarity, conviction and confidence.Â
- Develop plans (cost, timing, benefit, resources) for capital expenditures to introduce and rollout innovative technology. Analyze costs related to capital expenditures to determine break-even points, payback and associated hard and soft savings.
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Interaction
- Provide interface on key issues and problems with related organization.
- Coordinate activities with other organizations at department levels.
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Innovation
- Drive big data utilization with leverige historical data.
- Maintain secured infrastracture by IT/OT segregation.
- Drive paperless procedures.
- Develop plans to establish robust data integrity of manufacturing area.
- Strengthen OT network security by mitigating vulnerabilities and safeguarding critical assets against cyber threats.
- ãã¹ããªã¢ã³ãå©çšããããã°ããŒã¿æŽ»çš
- IT/OTåé¢ã«ããå®å šãªã€ã³ãã©ã®ç¶æ
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- çç£ãšãªã¢ã®å ç¢ãªããŒã¿å®å šæ§ã®å®çŸèšç»
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Complexity
- Collaborates with cross functional leaders to identify and prioritize automated systems.
- Collaborates with global engineering and global DD&T team to align technical/GMP wise.
- Provide local information to global and feedback global information to local.
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EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
- Bachelorâs degree or Master's degree of Engineering
- At least +10 yearsâ experience of engineering in pharmaceutical industry, including at least 7 years in Automation engineering.
- Must have business level of English/Japanese verbal communication ability and reading/ writing skills in English/Japanese
- People and organization management experience
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PREFERRED
- Experience of working in overseas countries
- Experience of IT/OT, MES and UPI development
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- IT/OTãMESãUPIã®éçºçµéš
ADDITIONAL INFORMATION
- This position offers an experienced individual a significant opportunity to establish best practices for Engineering of GMP manufacturing operations and Automations.
- Some travels will be required
- This job description is not designed to be a complete list of all duties and responsibilities required of the position.
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- ãã®è·åèšè¿°æžã¯ãè·äœã«å¿ èŠãªãã¹ãŠã®çŸ©åãšè²¬ä»»ãå®å šã«ç¶²çŸ ã§ãããããªæ§æã«ã¯ãªã£ãŠãããŸããã
Takeda Compensation and Benefits Summary:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
It is possible the job scope may change at the companyâs discretion.
It is possible the department and workplace may change at the companyâs discretion.
Locations
Hikari, JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeHead of Automation, Engineering (Hikari Plant) · Takeda Innovation Solutions Mexico S.A de C.V