Johnson & Johnson Careers

Microbiologist

Hägendorf, Switzerland
Biology


Job Description

Requisition ID: 1805675564W

"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

 

DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes 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.

 
Based on our site in Hägendorf we are looking for a highly committed
 
Microbiologist 100%


Tasks:

  • Establish and maintain procedures, tools and methodologies to cover the Environmental Monitoring (clean room, product, water monitorings) and contamination control programs
  • Maintain knowledge of FDA & ISO Environmental Monitoring and Product Cleanliness guidelines, as applicable
  • Conduct technical assessments of contract laboratories and critical suppliers
  • Perform risk assessments from a contamination control perspective
  • Provide guidance and training to personnel to ensure Environmental Monitoring program requirements are met
  • Working with Management to establish plant specific environmental monitoring requirements
  • Provide input on design of manufacturing processes, controlled environments and finishing, including cleaning, to ensure their efficacy, for obtaining clean and safe products
  • Provide input on design of systems to generate processed water
  • Support validation of processed Water, controlled environment and finishing/cleaning processes
  • Provide guidance to plant personnel, as required, ensuring good manufacturing and good documentation practice
  • Perform compliance tasks (CAPA, Nonconformances, Audit Observations) and support internal and external audits (Tüv, FDA, CFDA, etc.) 


Qualifications
  • Bachelor or Master degree in Microbiology or similar Work experience in the medical device and/or pharmaceutical industry is a must
  • Experience in environmental monitoring program and investigations is an advantage
  • Knowledge in associated regulations such as US FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001 is preferred
  • Strong knowledge in government regulations and industry guidelines for environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices is preferred
  • This position requires the ability to interact with managers at all levels as well as personnel at the operating unit level
  • The ability to work in cross-functional groups, in an environment that embraces teamwork
  • Business fluency in German and English
  • Travel up to 30% to other production sites 

If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.) via the following links


Primary Location
Switzerland-Solothurn-Hägendorf
Organization
Synthes GmbH (7111)
Job Function
Biology
Requisition ID
1805675564W