Senior Manager Manufacturing Engineering

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Job details

Company overview

We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world's leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.

Responsibilities

The Engineer – Automation will develop, implement, and continuously improve process automation solutions within Seishin Manufacturing to ensure that business goals are achieved for the Process Team they support. This position will require the development of expertise in production processes, commissioning, qualification, and validation requirements and equipment specific code and/or control system technologies.The Engineer–Automation is responsible for equipment performance, providing front–line support to production processes, and supporting area engineering initiatives, process improvements, and small project implementation. This will be done while ensuring that process automation solutions / systems are in-control, capable, and compliant.
Main responsibilities:

• Safety
  • Ensure a safe working environment by following HSE policies and helping to improve the safety culture within the process team.
  • Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvement.
  • Understand and support safe operation of the equipment within the area.
• Quality & Reliability
• Line Support
  • Act as first-tier support for automation systems, collaborating with engineers, fitters, and operations to troubleshoot/resolve downtime events.
  • Use control system and electrical data to identify root causes and implement corrective actions.
  • Understand production processes, critical parameters, and customer needs.
  • Evaluate and optimize automation code to improve performance and prevent issues.
  • Support deviation investigations and proactively address potential risks.
  • Ensure compliance with cGMP and site procedures.
• Project Implementation
  • Lead or support automation-related projects, including planning, contractor coordination, and execution.
  • Monitor and analyze data to drive improvements in data integrity, efficiency, and commercialization.
  • Ensure compliance with AQMS (Asset Qualification Monitoring Strategy), automation change strategy , and regulatory requirements.
  • Support commissioning and qualification (C&Q) activities and maintain validation documentation.
• Technical Contributions
  • Continuously monitor data and assess systems to identify improvement opportunities and implement changes.
  • Perform analysis to identify trends. Understand data trends of assigned area and proactively get involved and/or support discussion(s) and action plans.
  • Proactively evaluate automation code to identify and correct code opportunities to avoid product losses or overall performance of the line.
  • Initiate and implement change controls with supporting documentation and technical recommendations.
  • Define user requirements, system architecture, and automation code.
  • Copy, reuse and replicate standards and control code developed by others.
  • Manage contractors and ensure timely, cost-effective project delivery.
  • Maintain system administration (user management, patches, firmware updates).
  • Stay current with validation expectations and develop consistent validation practices.
• Broad Technical Knowledge
  • Understand process flow diagrams (PFDs), critical process parameters (CPPs), and control strategies.
  • Familiarity with data flow, S95, MES, SAP, and their integration with control systems.
  • Working knowledge of technologies such as PLCs, VFDs, vision systems, and MES configuration.
  • Ability to locate and interpret technical data to recommend and implement control improvements.
  • Document and share technical knowledge effectively.
• Collaboration & Knowledge Sharing
  • Participate in teams designated by supervision.
  • Attend and proactively participate in team meetings and huddle board discussions.
  • Contribute to team performance action plans.
  • Keep process teams and functions informed of activities and status, as applicable.
  • Identify all roadblocks and communicate to the appropriate level on time.
  • Represent the Automation area by sharing priorities, strategies, schedules, and project updates to team members.
  • Be influential and vocal in the teams.
• Compliance
  • Adhere to internal and external computer systems quality policies and procedures.
  • Maintain validated state of automation systems and report any risks or non-conformances.
  • Comply with GMP, Data Integrity Requirements, and Good Documentation Practices.

Requirements

Minimum requirements:

• Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.
• Ability to work safely to ensure the safety of self and others.
• Have a basic understanding of Infrastructure / Telecom.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE (Health Safety and Environment) Corporate and Site Goals.
• Japanese (with native fluency) and English communication (Read, write and conversation)
• From the perspective of employee well-being and productivity, the company has established a commuting distance and time limit policy.
• Specifically, the maximum allowable commuting distance is within 90 km and commuting time should not exceed 90 min from candidates nearest station to the workplace using the cheapest public transportation route. If candidates live further away than the above range, they will generally be required to relocate to a location within commuting distance (rented company housing may be provided). The above applies even if commuting by car is permitted.
• Engineering degree at university (or equivalent work experience)
• 8-hour days, after-hour on-call support.
• Occasional travel may be required for training, conferences, capital projects, etc

Preferred qualifications:

• Previous experience as a Process Automation Engineer or Process Engineer
• Experience in Pharmaceutical Manufacturing and familiarity with cGMP practices and procedures
• Knowledge of Computer System Validation (CSV) and Commissioning & Qualification (C&Q) or similar Capital Asset Delivery experience
• Proficiency in Ladder Logic programming and hands-on experience with Mitsubishi automation tools (e.g., GX Works, GX Developer, GT Designer)
• Experience with OPC communication protocols (e.g., OPC DA, OPC UA)
• Exposure to industrial data platforms and visualization tools such as OSI PI System, Power BI, or similar
• Strong problem-solving skills and analytical thinking

Salary

10 - 15 million yen

Location

Hyogo