Maintenance Calibration Engineer／Staff／GFE Head of Automation & Process Engineering, Yamagata Plant
Basic purpose of the job
Provides comprehensive engineering services to the Manufacturing, Packaging, Utilities departments, including maintenance, calibration, recovery, life cycle management, spare parts management, implementation of advanced technologies, preventive and autonomous maintenance, technical training, and support for qualification, validation, CSV, and GMP initiatives. Additionally, actively participates in the engineering network to leverage collective knowledge and experience.
Accountabilities
Engineering Service Delivery:
- Provides maintenance, calibration, and recovery services for MFG and PKG equipment and utilities.
- Oversees life cycle and spare parts management, including critical spares, inventory accuracy, and obsolescence mitigation.
- Implements preventive and autonomous maintenance programs and continuous improvement routines (e.g., Kaizen, 5S).
- Support Maintenance and Calibration Plan implementation and execution.
Technology & Projects:
- Evaluates, pilots, and implements advanced technologies to enhance reliability, capability, and productivity.
- Manages engineering projects with on-time, on-budget, and right-first-time delivery.
Compliance & Quality:
- Ensures adherence to GMP, CSV, and internal quality standards across all engineering activities.
- Supports equipment qualification and process validation (IQ/OQ/PQ); manages change control and CAPA actions.
Training & Capability Building:
- Delivers technical training to operators/technicians and maintains competency matrices and training records.
Safety & Sustainability:
- Promotes EHS culture; ensures LOTO, machine safety, and safe systems of work.
- Identifies and executes energy efficiency and waste reduction opportunities
Regulatory and / or Organisational Requirements
- Accomplish with Japanese Regulation requirements.
- Secure local and global Boehringer Ingelheim (EHS and Quality) standards and policies implementation
Job Complexity
- Requires balancing multiple priorities across maintenance/Calibration, compliance, and technology implementation.
- Involves coordination with cross-functional teams (Manufacturing, Packaging, Utilities, Logistics and Quality Assurance).
- Must manage both short-term operational needs and long-term strategic improvements.
- Requires troubleshooting complex technical issues under time constraints.
Interfaces
External: Regulatory Agencies, Suppliers, Entities
Internal: Yamagata departments and Global GFE Process Engineering Network
Job Expertise
- Analysis on repair/replace and technology upgrade options based on lifecycle cost and risk.
- Preparation on routine maintenance plans, calibration schedules, and critical spares stocking levels within delegated authority.
- Preventive/autonomous maintenance design and execution, Electronic maintenance and calibration systems, equipment qualification and validation, CSV/GMP compliance, reliability methods (RCM/FMEA), data analysis and reporting.
- Problem solving and critical thinking, stakeholder communication, collaboration, adaptability, leadership without authority, attention to detail, continuous improvement mindset, and knowledge sharing.
Job Impact
- Direct impact on equipment reliability, production efficiency, and compliance with regulatory standards.
- Supports cost optimization through effective maintenance, calibration and spare parts management.
- Enhances organizational capability by implementing advanced technologies and training operators.
- Strengthens knowledge-sharing culture within the engineering network.
Minimum Education/Degree Requirements
Degree/Education:
Bachelor’s degree
Focus:
Mechanical, Electro-Electronic or Electrical, Industrial, Mechatronics Engineer Or similar graduation.
Required Capabilities (Skills, Experience, Competencies)
Language:
- English: Advance level (read, write and speak)is desirable.
- Japanese: Advance (or Native) level (read, write and speak).
Work Experience:
- Over 2 year of Maintenance or/and Calibration Experience
- Pharmaceutical knowledge is highly desirable.
- Experience on international collaboration is desirable.
- Maintenance and Calibration Management System: Knowledge on SAP PM or similar management systems is desirable.
Hard Skills:
- Engineering Expertise: Strong knowledge of maintenance, calibration, and recovery processes.
- Life Cycle Management: Ability to manage equipment and systems throughout their operational life.
- Spare Parts Management: Proficiency in inventory control and spare parts planning.
- Advanced Technology Implementation: Capability to introduce and integrate cutting-edge technologies.
- Preventive & Autonomous Maintenance: Skills in designing and executing preventive maintenance programs.
- Qualification & Validation: Experience with equipment qualification,Computer System Validation and Good Manufacturing Practices.
- Technical Training Delivery: Ability to train operators and technical staff effectively.
- Data Analysis & Reporting: Competence in analyzing performance data and preparing reports.
- Engineering Network Collaboration: Familiarity with knowledge-sharing platforms and best practices.
Soft Skills:
- Problem-Solving: Strong analytical thinking to resolve technical issues efficiently.
- Communication:Clear and effective communication with cross-functional teams.
- Collaboration: Ability to work in a team and contribute to network initiatives.
- Adaptability: Flexibility to handle changing priorities and technologies.
- Leadership: Capability to guide and influence operators and peers.
- Attention to Detail: Precision in compliance, validation, and maintenance tasks.
- Time Management: Skill in prioritizing tasks and meeting deadlines.
- Continuous Improvement Mindset: Proactive approach to process optimization.
- Customer Orientation: Focus on supporting MFG and PKG departments effectively.
- Knowledge Sharing: Willingness to share expertise and learn from others.
Recruiter : Kuramoto