Job Detail

“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. 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.

Janssen Supply Chain a member of Johnson & Johnson Family of companies at Janssen Schaffhausen is currently looking for a Technical OperationsStaff Engineer Validation to be based in Schaffhausen, Switzerland. Janssen Schaffhausen Site/Cilag AG is a Launch site for New products with Focus on Parenteral Products Large Molecules and Small Molecules (e.g. Prefilled Syringes and vials).

POSITION SUMMARY:

As a Technical OperationsStaff Engineer Validation you will own the manufacturing processes and cleaning validations of 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 product and cleaning processes for the Janssen Supply Chain. This individual will provide the following:

• Technical support and leadership as LTO for end to end process reliability in Life cycle management


• Enhance reliability, compliance & efficiency of product value chains end to end


• Integrate Manufacturing Operations and Pharmaceutical Development in partnership with Product and Customer Management

PRINCIPAL RESPONSIBILITIES:

• Local Technical Owner for specific product and cleaning process reliability of commercial Drug products


• Validation of Manufacturing and Cleaning Processes and Process monitoring


• Owner of a Parenterals key competency as a Key Subject Matter Expert


• Active participation in inspections as a Key Subject Matter expert/LTO


• Validation and Maintenance of Aseptic Process simulation


• Validation of Automated Optical Inspection for specific products


• Implement Capability/Quality/Cost Improvement Changes


• Provide Technical Assessments to Change Controls/CAPA’s and Deviations, Investigation lead


• Own and Coordinate Validation/Monitoring Activities with Internal Partners


• Active participation in internal  inspections as Subject matter expert


• Maintain excellent partnership with all business partners

 




Qualifications

Professional Skills/ Personal & interpersonal skills / Leadership skills

• You have a University/Master Degree in Chemistry or Pharmacy 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 Manufacturing Process, Aseptic process simulation, Cleaning Requirements/Techniques and or Optical Inspection/Container Closure Integrity
  
  
  • 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
  
  

• Strong decision making and problem solving competencies


• Ability to effectively represent Technical Operations in cross-functional and cross-sites teams


• Fluent in both English and German


• Flexible, motivated and innovative team player


• Your are open to new ideas and you are driving innovation


• 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

Validation


Requisition ID

1805684823W