Sterility Assurance Specialist

Location: Leeds

Duration: 12 months initially

Hours: 37 hours p/w, hybrid. (Core hours 9am-4pm), flexibility on start and finish time 

Imagine your next project as a Sterility Assurance Specialist, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

The purpose of this role is to support the Sterility Assurance and Microbiology team in the application and practice of microbial assurance 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. This will involve: 

• To support the microbial assurance aspects of the Quality System.

• To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate.

• To co-ordinate use of all microbial services.

• To support the review and development of procedures for all microbial assurance activities.

• To carry out regular internal auditing of all clean room facilities and other areas.

• To implement the GMP training program for clean room and other appropriate staff.

• To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required.

• To support the release of sterile products.

• To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate.

• To create change controls identifying Microbial impact and necessary actions in line with WW and local procedures.

• To adhere to the Company’s procedures as detailed in the SOP manual.

• Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring.

• To support specific projects as allocated by the International Sterility Assurance Manager.

• All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.

how to succeed

You will be able to work on your own initiative and have a proactive approach to work. You will have a high attention to detail and be an excellent planner and organiser. You will also be computer literate. You will also bring:

• Experience working within Sterility (1+ years preferably)

• Familiarity with microbiological aspects of GMP regarding sterile medical devices.

• Experience of conducting GMP audits, internal and relevant external audits. 

• Degree level qualification grade 2:1 or higher, in one of the following areas: 

  • Medical Engineering

  • Mechanical Engineering

  • Biomedical Sciences

  • Microbiology

  • BioEngineering

details

This role is 80% desk based. 

This role offers a very competitive hourly rate. This contract will run for a 12 month duration and has a strong chance of extension. 

Hybrid (3 days on-site)

you are welcome here

DePuy is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about DePuy

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 & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

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”.