Sterility Assurance Scientist

Job description

Sterility Assurance Scientist
Leeds
GCF: 24

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is investing in early stage research and insights to build our long-term pipeline and enable us to implement innovative disease and care pathways on behalf of customers and the patients we all serve. As this investment includes attracting top talent, we have additional headcount to recruit a Sterility Assurance Scientist to join our team.

We offer exciting career opportunities for high caliber professionals. We provide value by delivering comprehensive contamination control, supporting our internal and external customers. At DePuy Synthes, a continuing focus on being agile, efficient and effective for the future is at the heart of what we do.

In this role you will support the Sterility Assurance team in the application and practice of contamination control as applied to the design, manufacture and sterilisation of implants while ensuring that the company meets all Corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements.

What you're great at:

You will be the subject matter expert for contamination control and sterilisation activities. You will be a strong collaborator who will build effective relationships with our Research & Development and Quality Operations partners. As an inner-directed professional, you will know when to escalate issues and always have our patients at the central to all thinking.

As the Sterility Assurance Scientist your typical day may include:

• Supporting the contamination control aspects of the Quality System.
• Carrying out regular environmental monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate.
• Co-ordinating use of all contamination control services and supporting the review and development of procedures for all microbial assurance activities.
• Regular internal auditing of all clean room facilities and other areas.
• Implementing the GMP training program for clean room and other appropriate staff.
• Be a member of New Product Development teams and undertake cleaning, microbial and sterilization validation.
• Supporting the release of sterile products.
• supporting the Quality team in the preparation for and performance of all third party inspections and audits as appropriate.
• Creating change controls identifying Microbial impact and necessary actions in line with WW and local procedures.
• To support specific projects as allocated by regional Sterility Assurance Leadership

Desired profile

Qualifications :

BE VITAL:

You will be degree qualified with demonstrated experience as a Microbiologist/related discipline in a medical device, pharmaceutical, or similar regulated industry. You will also have familiarity with microbiological aspects of GMP regarding sterile single use and reusable medical devices together with experience of conducting GMP audits, internal and relevant external audits.

Alongside:
• High Attention to Detail
• Flexible approach teamed with excellent Communication and Influencing Skills
• Strong Team Player who has a Pro-active approach to Work
• High level of Numeracy and excellent organisation skills

You will have a natural ability to sustain quality and service whilst driving improvements. It would be a distinct advantage is you were ISO 9001 Lead Assessor qualified.

What you'll own and how you'll grow:

You will be part of transforming and developing our contamination control and sterilisation activities on site and have the opportunity to share best practise and harmonise our activities within the wider global organisation. This role will offer you a localised position with global scope. We hope you will participate on one of our technical councils globally to support the wider enterprise.

What we're about:

We are passionate about our work, and 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. We share a kind of DNA where we're each

• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what's right

Make a unique mark in your career
Closing Date: 3rd June 2018

If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.

We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act.