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 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 Med Tech, 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 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.
• 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.

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.
• The Sterility Assurance Scientist technical areas supported include: cleaning and disinfection requirements, sterilization validation (microbiological testing to support the validation and maintenance of the sterilization processes and product label claims (e.g., bioburden, tests of sterility, endotoxin monitoring), environmental control and monitoring, water and air systems validation, compliance to applicable regulations and standards in the subject areas of sterility assurance and laboratories.

Qualifications

We would love to hear from YOU if you have the following essential requirements:

• Minimum bachelor’s in microbiology, Biology, Engineering, or related discipline.
• Minimum of 3 years’ 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 Power Point, and analytical software.

What’s in it for YOU?
This is an opportunity to work with a ground-breaking medical device operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the 1000 people who work here, or you’re considering joining the team, we offer:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.
• Possibilities for further personal and professional development/education.
• Excellent Benefits (Pension, Healthcare, Bonus, Onsite Gym among others).

What type of mark will YOU make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"!
For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.

Note:
Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description.