(Janssen) Manager, Engineering & Maintenance, Manufacturing and Supply Div., Fuji Plant

Position Summary :
Lead Engineering and C&Q (Commissioning and Qualification) Team at Fuji Site in alignment with/and implementing global guidelines , in following areas:
- Engineering and Project Management,
- Commissioning and Qualification plan and execution, guaranteeing a seamless transition to Validation activities from MSAT team
- Support/Collaboration with Execution Systems team and M&R (Maintenance and Reliability) team.
- Guarantee adequate training to all MAM team components on both capabilities and compliance areas.
Manage resources, organization and budget.
Conduct people development
Regulatory Compliance Responsibilities:
- Japanese law and regulation GMP/GCTP
- Ensure application of EHS&S policies and procedures (contractor safety, work permits, etc.) as well as Code of Business Conducts

• Ensure application of Quality policies and procedures and support continuous quality improvement initiatives at Fuji Site

Major Job Duties and Responsibilities:
Appointed Production Equipment Control Manager at Fuji Site GMP/GCTP organization and perform the role
Technology area is related to inspection machine, packaging line, and automation
Responsible for
• Engineering work/Project management for production equipment/system introduction
• URS, IOQ, PQ for new equipment/ system and/ or modification of existing equipment/ system for new product or business/ quality/EHS/ maintenance purposes
• Maintenance/calibration plan and execution
• TPM / Lean 6 sigma
• Trouble shooting
• Documentation
• Training
• Standard (SOP, WI, Form)Education and Experiences:
BS 12-15 yrs.
MS/MBA/Ph.D. 10 yrs. PE Certification desired
Knowledge, Qualification and Skills:
Proven track record in Project Engineering/Management in the pharmaceutical industry including design construction and commissioning and qualification.
Strong capabilities in pharma maintenance, especially packaging equipment, and reliability areas
Experience in managing the maintenance function in the pharmaceutical or allied industry (food/beverage/cosmetic).
Proven leadership skills and the ability to develop talent.
Strong communication and interpersonal skills.
Core Competencies :
Decision making, problem solving and priority setting based on strategy.
Innovation/Creativity.
Communication at different level of organization with capability to influence stakeholders both at and above Site.
Credo based Leadership / Servant Leadership
Connections with both internal and external function/organization.
Resilience.