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Capgemini

Global consulting, technology services, outsourcing

Automation Development Lead - Pharmaceuticals, Medical Devices Engineering / Engineering

Controls & Automation EngineeringUpdated on Nov 14
Full-timeTokyo, JapanNo salary listed

About the Job

Requirements

  • Five years of experience in computer system validation or automation/development in active pharmaceutical ingredient or drug product manufacturing.
  • A proactive attitude toward expanding responsibilities and improving capabilities.
  • Japanese language ability from conversational to business level and business-level English.
  • Ability to travel domestically in Japan as needed.
  • Programming skills in programmable logic controllers are preferred.
  • Experience with good manufacturing practice and information technology/operational technology/process technology management is preferred.

Responsibilities

  • Support the design, implementation, and maintenance of automation systems in pharmaceutical plants and field locations.
  • Improve the efficiency and quality of pharmaceutical manufacturing processes by optimizing manufacturing equipment, maintaining quality management systems compliant with good manufacturing practice, improving productivity, reducing costs, and leading technical innovation.
  • Support internal and external audits, implement standards, and create regional or site standard operating procedures and templates as needed.
  • Negotiate contracts and close deals to achieve sales targets.
  • Develop and implement code and recipes for distributed control systems, supervisory control and data acquisition systems, programmable logic controllers, and control networks.
  • Design, implement, and maintain historian configurations for modules, visualization, and operational expenditure.
  • Perform software change management related to automation and system changes.
  • Own and develop automation solutions that meet specific manufacturing environment needs.
  • Contribute to preparing appropriate and cost-effective solutions for automation investment projects, leveraging best practices and expertise across the engineering network.
  • Design and implement manufacturing execution system master batch records.
  • Drive site-level automation deployment processes to meet cost, schedule, and technical solution targets.
  • Operate and manage operational technology systems, tools, and applications to ensure stability and integrity and meet customer service levels.
  • Support operational technology system business owners on technical topics, operate information technology and operational technology services, systems, and applications, and monitor events in the enterprise environment.
  • Ensure configuration items are identified, accounted for, reported, verified, and audited.
  • Implement and execute end-to-end processes required for operational technology systems and cybersecurity requirements.
  • Maintain current inventories of all technical assets.
  • Ensure compliance with security and compliance policies and procedures.
  • Prepare tools and spare parts for maintenance and calibration, identify maintenance spares, and maintain pick lists.
  • Prepare maintenance and calibration method statements and conduct related risk assessments.
  • Obtain permits for maintenance, calibration, and projects.
  • Execute maintenance and calibration work instructions in accordance with method statements and procedures.
  • Provide frontline support to technicians, assess quality impact, and release equipment after maintenance.
  • Archive maintenance documentation and execute change requests.
  • Investigate deviations and perform root cause analysis.
  • Create, maintain, and verify engineering documentation, including protocols, drawings, lists, schedules, diagrams, layouts, calculations, and data sheets.
  • Coordinate and assign technicians or managed-service vendors at sites and clusters according to plan, ensuring agreed calibrations are performed.
  • Perform project risk assessments and identify technical solutions.
  • Prepare project equipment specifications and system requirements, such as user requirement specifications, and prepare functional specifications.
  • Prepare, review, and approve project drawings, lists, schedules, diagrams, layouts, calculations, and data sheets.
  • Conduct factory acceptance testing, site acceptance testing, and inspections for new project equipment.
  • Execute project work instructions in accordance with method statements and conduct commissioning activities.
  • Perform or support requalification.
  • Conduct good manufacturing practice risk assessments, including sensor safety risk assessments.
  • Prepare and execute design qualification, installation qualification, and operational qualification protocols.
  • Provide technical troubleshooting during performance qualification and validation.

Desired Qualifications

  • Programming skills in programmable logic controllers.
  • Experience with good manufacturing practice and information technology, operational technology, and process technology management.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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