Technical Systems Lead (facility) RLT Sasayama

Summary

-Manages and supervises the building design and construction of new businesses as they are set up. Responsible for the selection and management of external suppliers. Responsible for managing the overall schedule and budget.

About the Role

Major accountabilities:

• Build and maintain strong relationships with internal and external Novartis stakeholders, particularly strong working relationships to ensure effective and seamless collaboration with the Operations Centre and Site Development.
• Set up, troubleshoot, and maintain the entire packaging floor in all formats within the timeframe required to meet departmental expectations and efficiencies.
• Improve the effectiveness of operations by researching process methods, making recommendations for improvements, and assisting in the implementation of such improvements.
• Maintain FDA-compliant operations with appropriate documentation.
• Support engineering studies, validation, FAT and qualification and provide input to equipment-related SOPs.
• Maintain compliance with SOPs, Good Documentation Practice (GDP), training requirements, company and safety policies (e.g. lockout/tagout) and current good manufacturing practice (cGMP).
• Support other lines and roles as required to maintain operational efficiency and production output without compromising quality or safety.
• Comply with all applicable procedures, cGMPs, company policies and all other quality or regulatory requirements (e.g. OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
• Ensure that all work is performed in a safe and effective manner and in compliance with appropriate industry and regulatory (FDA, DEA, OSHA) standards, as well as departmental, plant and corporate quality and safety behaviors
• Training of machinery and packaging personnel

• No academic qualifications required.
• English language skills at business level and the ability to communicate fluently in Japanese.
• Experience in engineering project management.
• Experience in production and manufacturing engineering and the ability to design to EHS standards.

• Knowledge/experience of general contracting is a plus.
• Experience/knowledge of GMP and Radioligand Therapy
• Experience in clean room design and construction