Technical Systems Lead (facility) RLT Sasayama

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

Essential Requirements:

• 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.

Desirable Requirements:

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