Sterility Assurance Scientist

Sterility Assurance Scientist

Location: Cork

Duration: 12 months

Hours: 39 hours

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

The Sterility Assurance Scientist will support in the areas of aseptic processing, contamination control, sterilization, reprocessing and microbiology.  He/she will support product manufacturing activities.  

Roles and Responsibilities

• R&D – 

  • provide technical support in the validation of aseptic manufacturing and sterilization methodologies 

  • support contamination control and sterility assurance requirement in the integration of acquisitions and new product licensing 

  • provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally

• Plan – 

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

• 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, non-sterile 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

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

• 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 corrective action plan for microbiological or contamination control CAPAs and non-conformances, including root cause identification and corrective action implantation within agreed timelines

  • supports technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers.

  • provide technical support during onsite inspections

  • work with internal and external laboratories to support sterility assurance testing requirements.  

  • work with the local Sterilization Execution organization to support the release of sterile product, and addressing any issues that might arise during the execution of the sterilization processes

• Deliver – 

  • support the ongoing initiatives regarding the validation of primary non-sterile and sterile packaging systems that meet the needs of distribution system and delivery of sterile or microbiologically controlled product to the patient and/or consumer

• External Influencing – 

  • develop knowledge on best practices in sterility assurance and contamination control by interacting with JJSA leadership. 

• Internal Influencing – 

  • interacts with product development teams to ensure objectives and project timelines 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 Assurance Councils

How to Succeed

• An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required; an advanced degree is desirable.

• A minimum of 1 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required.  

• Competent in using computer software such as Excel, Word and PowerPoint, and analytical software.

Benefits

This role offers a very competitive hourly rate. This contract will run for 12 months.

about DePuy Synthes

DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS™ Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes. 

https://www.jnjmedtech.com/en-US/companies/depuy-synthes

https://www.jnjmedtech.com/en-GB/companies/depuy-synthes

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.