- A major pharmaceutical company is investing into a new aseptic cartridge filling capacity in an existing site. This project includes a high-speed filling line, two formulation skids, two components processor, one dispensing isolator, infrastructure, and utilities modifications.
- This role will be expected to develop and execute Engineering documentation for the project. The overall project will be expected cover a duration of 24months.
- The project will be implementing in existing building where all utilities supply will have to be modified for the new process equipment’s. Clean and Black utilities will be concerned by modifications. Regarding HVAC systems, existing installation will be modified, and additional installations will be required. Dedicated studies will be performed for modifications required
- The C&Q HVAC engineer will be in charge for Commissioning & Qualification execution of HVAC packages.
- As first mission, he will be in charge for preparation of all Commissioning & Qualification protocols for the package that he will be assigned, and he will make sure that all documents are reviewed and approved in time. In the second time, he will coordinate, execute, and complete Commissioning & Qualification that shall be perform from initial testing during FAT until final Qualification acceptance of concerned package.
- Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning documents.
- Preparation of documents associated with C&Q activities.
- Preparation and execution of FAT, and SAT protocols
- Review equipment specifications to ensure FAT, SAT and PIM requirements are included, as appropriate.
- Preparation and execution of Qualification protocols (IQ,OQ, PQ)
- Design Qualification (DQ) protocol preparation, execution, and follow-up
- Field Walkdowns of systems as part of transfer of ownership of the system from Construction
- Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
- Nonconformity management during project lifecycle
- Summary Report writing
- Organize and review daily tasks/verifications and track the progress of the activities assigned.
Candidate requirements :
- BS Engineering (or equivalent experience)
- Strong knowledge on HVAC qualification
- Minimum 5 years’ experience on Capex projects in the pharmaceutical (Sterile projects is a plus)
- One significant experience within brownfield project
- Good Knowledge of GMP’S, regulatory requirements
- Good written and verbal communication skills with both technical and non-technical staff (French+English)
- Ability to communicate clearly in an engaging manner with colleagues of various levels of experience (stakeholder management)
- Comfortable working in a matrix environment, convincing others and having strong level of adaptability.
- Strong Analytical and problem-solving skills
- Ability to work in a fast-paced environment and working with strict timelines and deadlines (time management)
- Ability to work independently and as part of a team