Summary
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
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
