Process Technology Expert

Improving and optimizing production processes by proposing changes and implementing solutions in cooperation with the MS&T department and other plants of the Polpharma Biologics group. You will be responsible for process technology supervision in Drug Substance manufacturing process with main focus on Single Use systems and Hybrid systems (Stainless Steel and Single Use systems). Participation in technology transfer in accordance with cGMP regulations and internal SOPs during the implementation of projects related to the introduction of new biotechnology products. Participation in process validation, acting as an SME in topics involving Single Use Technology. Participation in  manufacture of biotechnology products in accordance with GMP principles and regulatory requirements to obtain a product of specified quality in the specification.

• Supervision and monitoring of manufacturing line performance during bioprocessing in accordance with the principles of GMP, technological documentation and other internal requirements;
• Planning and initiating activities regarding production processes optimization and manufacturing platform optimization;
• Creating guidelines and recommendations for other Teams of the Production Department;
• Point of contact to define User Requirements and review of operational parameters of Single Use systems, verification of item compatibility within manufacturing line and support of Quality team in defining or review of quality requirements;
• Participation in equipment/facility expansion projects, serving as a point of contact with external parties to review and propose technological solutions;
• Participation in the technology transfer in terms of implemented manufacturing processes of active substance in the production area;
• Participation in the elaboration of pre-validation/validation strategy in alignment with process validation lead, including supportive studies;
• Participation in monitoring and continuous verification of the active substance manufacturing process in regards to the Design Space of bioprocessing line;
• Review key documents & coordinate input for relevant registration documents for accuracy & completeness (as appropriate);
• Documentation preparation according to GMP rules and internal company requirements.
• Acting as the owner of technical change in accordance with GMP change management processes for a new and / or improved product, equipment and process through implementation, validation in a GMP environment.
• SME and action owner in Investigation actions, Change Controls, Risk Assessments and CAPAs involving bioprocessing technology subjects
• Development and verification of design documentation and equipment qualification documentation, actively supporting qualification execution
• Elaboration of SOPs and manuals (including manuals to equipment).
• Close cooperation with MSAT, Production Operational Department, Engineering Department and Quality Department.
• Work organizing and impact on the work of others in order to make the most effective use of working time and performance of tasks.