Senior Sterilizaton Scientist-00000HPK
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world, built upon the strong legacies of two great companies. We are a total solutions company. DePuy Synthes Companies offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high quality offerings help advance the health and wellbeing of people around the world.
Position Responsibilities
Essential Functions:
The successful candidate would become the company’s expert on the application and practice of microbial assurance as applied to the design, manufacture and sterilisation of orthopaedic products for the Leeds facility.
- To ensure that the company meets all internal and regulatory requirements including, but not limited to: US FDA, Medical Device Directive and European Standards.
- To implement the microbial assurance aspects of the Quality System
- To carry out regular microbial monitoring of clean room facilities, to analyse results and recommend corrective actions where appropriate
- To oversee/co-ordinate the use of all microbial services
- To review and develop procedures for all microbial assurance activities
- To carry out regular internal auditing of all clean room facilities and other defined areas
- To implement the GMP training programme for clean room and other appropriate staff
- To validate gamma, ethylene oxide and gas plasma sterilisation processes for existing and new products to EN standards
- To develop alternative technologies that could be applied to future products
- To regularly audit sterilisation, packaging and clean room clothing suppliers
- To provide advice and guidance on new packaging technologies, and validations, and to keep abreast of corporate requirements
- To validate all microbial aspects of new products and packaging
- To adhere to the company’s standard operating procedures
Non-Essential Functions:
- Participate in internal auditing
Job Environment
Circumstances (Situational Factors):
Based at the Beeston site, Leeds. Will interact as a member of the Quality Assurance team in an office environment.
Contacts/Involvement:
The Sterilization Scientist would work closely with the following interfaces to maintain a high degree of microbial assurance throughout the facility: -
- Quality Assurance Manager
- CMW Microbiology Manager
- Production Managers
- Maintenance Supervisor
- Cleaning and Packaging Staff
- Sterilisation Subcontractor
- Bioengineers
- Production Engineers
- Packaging Engineers
- Packaging, and Clean room Equipment suppliers
- J&J CQA and Sterilisation Sciences personnel
To work as part of a high performance team. Opportunities for cross-functional training.
Additional hours may be required for cross shift training. Continual prioritization of work required.
Qualifications
A degree in Microbiology required. A familiarity with regulated industry is strongly preferred. Quality systems experience a plus.
Skills and Abilities (Can Do Criteria):
Relevant experience as a microbiologist in a medical, pharmaceutical, or similarly regulated industry is required. Should also be familiar with microbiological aspects of GMP regarding medical devices, and auditing practices for relevant internal and external audits
Personal Traits (Will Do Criteria):
Must have the initiative and ability to investigate, plan and execute those actions required to constantly improve and develop the company’s microbial assurance levels. An organised, and logical approach to training, documentation, and audit requirements is also essential. A professional approach, when dealing with internal, corporate, regulatory or supplier representatives is also required.
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Leeds
Organization: Depuy Int'l Ltd. (8722)
Job Function: R&D Engineering (Eng)
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world, built upon the strong legacies of two great companies. We are a total solutions company. DePuy Synthes Companies offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high quality offerings help advance the health and wellbeing of people around the world.
Position Responsibilities
Essential Functions:
The successful candidate would become the company’s expert on the application and practice of microbial assurance as applied to the design, manufacture and sterilisation of orthopaedic products for the Leeds facility.
- To ensure that the company meets all internal and regulatory requirements including, but not limited to: US FDA, Medical Device Directive and European Standards.
- To implement the microbial assurance aspects of the Quality System
- To carry out regular microbial monitoring of clean room facilities, to analyse results and recommend corrective actions where appropriate
- To oversee/co-ordinate the use of all microbial services
- To review and develop procedures for all microbial assurance activities
- To carry out regular internal auditing of all clean room facilities and other defined areas
- To implement the GMP training programme for clean room and other appropriate staff
- To validate gamma, ethylene oxide and gas plasma sterilisation processes for existing and new products to EN standards
- To develop alternative technologies that could be applied to future products
- To regularly audit sterilisation, packaging and clean room clothing suppliers
- To provide advice and guidance on new packaging technologies, and validations, and to keep abreast of corporate requirements
- To validate all microbial aspects of new products and packaging
- To adhere to the company’s standard operating procedures
Non-Essential Functions:
- Participate in internal auditing
Job Environment
Circumstances (Situational Factors):
Based at the Beeston site, Leeds. Will interact as a member of the Quality Assurance team in an office environment.
Contacts/Involvement:
The Sterilization Scientist would work closely with the following interfaces to maintain a high degree of microbial assurance throughout the facility: -
- Quality Assurance Manager
- CMW Microbiology Manager
- Production Managers
- Maintenance Supervisor
- Cleaning and Packaging Staff
- Sterilisation Subcontractor
- Bioengineers
- Production Engineers
- Packaging Engineers
- Packaging, and Clean room Equipment suppliers
- J&J CQA and Sterilisation Sciences personnel
To work as part of a high performance team. Opportunities for cross-functional training.
Additional hours may be required for cross shift training. Continual prioritization of work required.
Qualifications
A degree in Microbiology required. A familiarity with regulated industry is strongly preferred. Quality systems experience a plus.
Skills and Abilities (Can Do Criteria):
Relevant experience as a microbiologist in a medical, pharmaceutical, or similarly regulated industry is required. Should also be familiar with microbiological aspects of GMP regarding medical devices, and auditing practices for relevant internal and external audits
Personal Traits (Will Do Criteria):
Must have the initiative and ability to investigate, plan and execute those actions required to constantly improve and develop the company’s microbial assurance levels. An organised, and logical approach to training, documentation, and audit requirements is also essential. A professional approach, when dealing with internal, corporate, regulatory or supplier representatives is also required.
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Leeds
Organization: Depuy Int'l Ltd. (8722)
Job Function: R&D Engineering (Eng)