Sterility Assurance Scientist

Johnson & Johnson is currently seeking a Sterility Assurance Scientist to join our validation team located in Loughbeg, Cork.

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

This position will report into a Sterility Assurance Supervisor or a Sterility Assurance.

The work environment is primarily in a local office, and may require frequent interactions with manufacturing.

The individual must be able to comply with established safety procedures and policies to maintain a safe working environment to ensure compliance with J&J environmental policies.

What you will be doing:

The Sterility Assurance Scientist is responsible to support the end-to-end implementation of contamination control and sterility assurance policies for the manufacturing of commercial products within Global Orthopaedics.

The defined make organizations include Cork, Ireland, as well as supporting defined suppliers.

The Sterility Assurance Scientist will support in the areas of, contamination control, sterilization, and microbiology.

They will support product manufacturing activities.


* Working in a dynamic team.


* The release of product


* Co-ordinating testing with contract laboratories (including environmental monitoring, water sampling & product testing)


* Conducting investigations


* Report writing


* Assessment of changes from a contamination perspective and


* Driving improvements.

The successful candidate will work with cross functional teams including quality and operations

What impact will you have:

Source


* Provide support in 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, nonsterile, or microbiologically controlled products that are externally manufactured.


* Support requirements for new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing.


* Provide support in the design of critical water and air systems and the design of controlled environments and cleanliness control strategies.

Make


* Support cross-functional compliance to the end-to-end sterility assurance policies at defined manufacturing facilities in Cork, Ireland.


* Ensure process changes meet contamination control and sterility assurance requirements.


* Support the investigation, gap analysis, and develop the...