Process Expertise & Validation Specialist (h/f)

Job content

• Support process troubleshooting and continuous improvement for the pharma processes by performing small-scale studies in our lab,Schedule,
• prepare and execute small-scale studies and experimental activities, and write associated protocols and reports,
• Ensure adherence to the site Validation Master Plan,
• Lead process validation and cleaning validation/verification, including the definition of the validation strategy:
• Drive and write validation risk assessments, change-over protocols and change controls for current and new processes as Validation & Process Expert,
• Write validation plans, protocols and reports,Provide expertise in validation and process knowledge during investigations,
• Change Controls and projects for chemical and pharmaceutical processes,
• Implement new processes and support the Tech Transfer activities for chemical and pharmaceutical processes,Lead and ensure the implementation of CPV for new processes:
• Definition of the initial CPV plan, creation of the initial CPV report,
• Creation of the routine CPV plan and participation to the routine CPV committees as SME for the CPV requirements and methodology,
• Lead complex CPV investigations,
• Act as a Subject Matter Expert (SME) for selected topics such as Process Validation, Cleaning Validation, CPV, etc
  

• A university degree in chemical engineering,
• A minimum of 2-3 years of experience in a relevant field;
• Show a pro-active, customer-oriented, results-driven, positive, can-do attitude,
• Be problem-solving and solutions oriented,
• Prove your ability to take sound, fast and courageous decisions and think outside the box,
• Be a team player across different teams and different levels of the organization,
• Fluent both in French and English,
• Be engaged to impact patients’ lives.