Senior Scientist Sterility Assurance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description:

Position: Senior Scientist

Title: Senior Scientist Sterility Assurance

Project Management

Global Orthopedics

Description

The Sterility Assurance Senior Scientist, Project Management is responsible to support the end-to-end implementation of strategic projects associated with contamination prevention and sterility assurance across the make/deliver and product development teams for Global Orthopedics and will support programs to be aligned with the overall J&J Sterility Assurance programs.

The Senior Scientist will serve as a technical support leader in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology.  He/she will support strategic and tactical projects across the network, including R&D and manufacturing organizations.  This position is responsible for compliance to applicable Quality Regulations and standards.

This individual will be responsible for activities such as, but not limited to, the following:

• R&D –

  • Maintain central GO policy documents; update and ensure integration cross-franchise as directed.

  • Support due diligence on contamination prevention and sterility assurance for acquisitions and new product licensing.  Develop plans on integration post-acquisition of determine needs on divestiture.

  • Drive innovation to provide novel methodologies, processes or strategies for contamination prevention and sterilization. 

  • Support research or investigatory studies

• Plan –

  • Provide support in the development and selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)

• Source –

  • Provide support in Business Unit/Franchise due diligence for sterile, non-sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J

  • Provide technical SME support for procurement activities that relate to sterile, non-sterile or microbiologically controlled products that are externally manufactured

  • Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint

  • Provide technical SME support for sterility assurance and contamination control in supplier audits.

• Make –

  • Support the alignment of central GO policy documents for contamination prevention and sterility assurance in accordance with franchise, corporate and applicable international standards; support the update of and ensure integration cross-franchise as required.

  • Maintain knowledge of best practices, standards and guidance in sterilization, processing, aseptic technique and environmental monitoring. 

  • Support key supplier management and audits, including point of contact for define strategic collaborations

  • Support opportunities for business continuity planning for sterilization and contamination prevention across GO

• Deliver –

  • Customer engagement and support, monitoring trends in Customer needs with feedback to Management

• External Influencing –

  • Monitors best practices in sterility assurance and contamination control by interacting with JJSA leadership.

• Internal Influencing –

  • Interacts with business leaders to ensure objectives and project prioritization meet business needs.  Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities. 

  • Participate on the J&J Sterility Ass