Spécialiste transfert technologique

2 months ago

Candiac, Canada Pharmascience Full time

The Technology Transfer Specialist Expansion Project ensures the transfer activities of injectable products and processes in the expansion of the sterile facility. He/she develops/adapts production processes for the transfer of products from the current line to the new vial filling line. He/she also supports with his/her technical expertise the visual inspection and packaging automation project.

Responsabilities & Duties 

Establishes the transfer of existing processes to the rooms of the expansion, improving them as required. Develops the filtration strategy in grade C and ensures the introduction of new consumables (connectors, tubing, filters, weighing bags, etc.) in the expansion of the injectable plant. Ensures the transfer of weighing for injectable products into the weighing isolator. Plans, coordinates and sees to the execution of the various studies for the transfer of products to the new vial filling line (compatibility, feasibility, capability studies, holding times, recirculation, purging, etc.) according to the project deadlines. Performs the freeze-drying cycles of the products on the new equipment. Develops new processes linked with new equipment (use of RTP ports, aseptic techniques under isolator, in-situ integrity tests of filters and gloves, etc.) according to project timelines. Writes protocols, reports, technical notes and notices of changes related to the transfer of products. Prepares the side-by-side comparison of processes between the current and the transfer in the expansion. Contributes to the optimization of manufacturing processes and update of the BOM. Supports production during the manufacturing of engineering, validation and submissions batches. Train and support production employees, supervisors and specialists from other departments on new processes. Supports the execution of aseptic manufacturing and filling simulations (media fill) of new processes. Act as a content expert for writing procedures regarding injectable equipment and processes, production master files and aseptic simulations. Act as a technical expert for the visual inspection and packaging automation project and supports visual inspection recipe creation. Participates in investigations following deviations and non-conformities observed during the qualification of new equipment. Apply and ensure compliance with Health & Safety rules.

Habiletés, connaissances et aptitudes 

Good aptitude for teamwork, autonomy and sensible to client needs Ability to write and interpret technical documents Ability to effectively manage time and priorities Ability to manage multiple folders simultaneously Continuous process improvement approach Skills in problem solving Easy to interact and excellent ability to communicate with people Proficient with MS Office Good knowledge in aseptic area Lean Six Sigma Green Belt Certification an asset

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