Microbiologist (Sterility)- LEEDS

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
 

The Project:

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.
 

ORGANISATIONAL INTERFACES:

Sterility Assurance Team Personnel, International Sterility Assurance Manager, Cleaning & Packaging Staff, Sterilization Sub Contractor, QC Laboratory Sub-Contractor, QA Engineers, New Product Development Engineers, Manufacturing Engineers, DePuy Synthes WW Sterilization Assurance Personnel, J&J Corporate Sterilization Assurance Personnel. 
 

The Role:

• 12 month contract
• Leeds- Hybrid
• £20-25 p/h PAYE (Higher LTD Available)

Duties and Responsibilities:

1. To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate.
2. To co-ordinate use of all microbial services.
3. To support the review and development of procedures for all microbial assurance activities.
4. To carry out regular internal auditing of all clean room facilities and other areas.
5. To implement the GMP training program for clean room and other appropriate staff.
6. To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required.
7. To support the release of sterile products.
8. To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate.
9. To create change controls identifying Microbial impact and necessary actions in line with WW and local procedures.
10. To adhere to the Company’s procedures as detailed in the SOP manual.
11. Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring.
12. To support specific projects as allocated by the International Sterility Assurance Manager.
13. All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.

Qualifications:

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

• Medical Engineering

• Mechanical Engineering

• Biomedical Sciences

• Microbiology

• BioEngineering

DESIRABLE: ISO 9001 Lead Assessor qualification.

Post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.

Familiarity with microbiological aspects of GMP regarding sterile medical devices.

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

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is Inside IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 
 

Thank you very much and we look forward to receiving your application. 

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”.

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

• Medical Engineering

• Mechanical Engineering

• Biomedical Sciences

• Microbiology

• BioEngineering

DESIRABLE: ISO 9001 Lead Assessor qualification.

Post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.

Familiarity with microbiological aspects of GMP regarding sterile medical devices.

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

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is Inside IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application. 

If you would like some additional information about the role please contact: 
courtney.wells@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”.