Johnson & Johnson Careers

Staff Engineer Validation

Schaffhausen, Switzerland
Process Engineering


Job Description

Requisition ID: 1905755425W

“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 is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
 
Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the “Janssen Pharmaceutical Companies of Johnson & Johnson” trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. 
Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
 
Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a

Technical Operations Staff Engineer Cleaning Validation



As a Technical Operations Staff Engineer Cleaning Validation you will own the End to End responsibility for Cleaning validation and concept for commercial products for non-biologic and biologic parenteral liquids, suspensions and lyophilized products at the Schaffhausen Fill Finish site as Local Technical Owner (LTO).

You will be the site Technical Operations representative on cross functional teams owning the responsibility for the reliability of cleaning processes for the Janssen Supply Chain. This individual will provide the following:

  • Technical support and leadership as LTO Cleaning with  end to end  responsibility in Life cycle management for the Schaffhausen site
  • Enhance reliability, compliance & efficiency of cleaning in product value chains end to end
  • Integrate Manufacturing Operations in partnership with Product and Customer Management
PRINCIPAL RESPONSIBILITIES:
  • Site Technical Owner for Cleaning validation and Cleaning Life Cycle managment End to End
  • Validation of Cleaning Processes and Monitoring  NPI/Tech Trasnfers and Legacy Drug products Cleaning
  • Active participation in inspections as a Key Subject Matter expert/STO for Cleaning
  • Backup Function for LTOs for Aseptic Process Simulations and/or Sterilisation/Decontamination process validation/Monitoring
  • Implement Innovation/ Quality/Cost Improvement Changes/Digitalisation
  • Provide Technical Assessments to Change Controls/CAPA’s and Deviations
  • Investigation lead for Cleaning process Investigation, owning key cleaning competency
  • Owner of additional Parenterals key competencies as a Key Subject Matter Expert
  • Own and Coordinate Validation/Monitoring/Investigation Activities with Internal Partners
  • Maintain excellent partnership with all business partners on site and in the organisation of JSC
  • Driving our data solutions (report automation, modelling, simulations e.g.)


Qualifications
  • You have a University or Master Degree in Life Sciences or Engineering (e.g. Chemistry/ Biochemistry/ Pharmacy/ Engineering/ Computational Science  or Equivalent)
  • You have at least 5+ years related experience in the pharmaceutical sector overall with past proven field experience in several of the following areas:
    • Experience in Parenteral Drug product development, Operations, Manufacturing Process, Cleaning Requirements/Techniques
    • Process Automation or Data Specialist
    • Experience in Leading GMP Investigations
    • Ability to operate in a complex global matrix organization with multiple stakeholders
    • Knowledge of Quality Assurance and Regulatory Compliance cGMP and EH&S
    • Project Management
    • Passion and curiosity for data analytics and data crunching/ data solutions (Simulation, Modelling, Data Management or similar)
    • First experience with data analytics and machine learning preferred
 
  • Strong decision making and problem solving competencies
  • Ability to effectively represent Technical Operations in cross-functional and cross-sites teams
  • Digital and Analytics Talent for creative but pragmatic solutions
  • Flexible, motivated and innovative team player
  • Excellent communication and negotiation skills
  • Fluent in both German and English
We are offering

a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure at the Janssen site Schaffhausen.



Primary Location
Switzerland-Schaffhausen-Schaffhausen-
Organization
Cilag AG (8562)
Job Function
Process Engineering
Requisition ID
1905755425W