Commissioning & Qualification Engineer

About the role

Johnson & Johnson is seeking a Commissioning & Qualification Engineer to support equipment changes and new product introductions at its Fuji plant in Shizuoka. The role ensures quality and regulatory compliance of manufacturing equipment and systems while collaborating across functions.

Key responsibilities

• Lead commissioning and qualification (C&Q) activities for equipment modifications and new product introductions, ensuring compliance with GMP/GCTP and company policies.
• Develop protocols, execute qualification tests, analyze data, investigate deviations, and prepare C&Q documentation and reports.
• Collaborate with Manufacturing, Quality Assurance and other departments to drive smooth execution of C&Q activities.
• Troubleshoot technical issues, equipment failures and quality problems, leading root‑cause investigations and corrective actions.
• Supervise vendor construction activities in manufacturing areas and enforce EHS safety standards.

Required profile

• Practical experience with equipment and system activities related to new product introductions, start‑up, modification or validation.
• Background in mechanical, control or OT technologies in a production environment.
• Experience in the pharmaceutical, cosmetics or food industry is desirable.
• University degree in engineering or equivalent technical education.
• Ability to work independently with minimal supervision and strong organizational skills.

Required skills

• Commissioning and qualification of manufacturing equipment.
• Validation and GMP/GCTP compliance.
• Mechanical, control and OT technology knowledge.
• Data analysis and deviation investigation.
• Technical documentation and report writing.