Your technical environment
Joining FORTIL Switzerland means joining a team of experts, business engineers and recruiters. Established in Geneva, our expertise is in Energy, Transport and Life Sciences.
FORTIL guides start-ups and big groups and meet their needs by providing skilled and talented project teams and individual consultants. We deploy custom-made solutions to offer relevant advice and we put our know-hows and recruitment experiences to the service of our clients’ projects.
Your job responsibilities
• Qualification/Validation Master plans are up to date and established for all ongoing projects
• You will write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
• You will be in charge of DQ, IQ, OQ, PQ, execution, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
• You will plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
• You will prepare,review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
• You will coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
• You are responsible for the coordination and oversight of external suppliers
What you need to succeed
• You evolved in the Pharmaceutical and / or Biotech, or equivalent
• You are competent with current FDA and EU regulations and best practices
• Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
• You are fluent in French and English.
Your profile and personality
Master’s degree in scientific or engineering discipline and minimum 4 years of experience in equipment commissioning, qualification and validation (IQ, OQ, PQ)
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