Experience

Polpharma Biologics

• Poland
• Biotechnology Research
• 700 & Above Employee

• Hygiene and Process Support Manager

  • Jun 2023 - Present

  Gdańsk, Woj. Pomorskie, Polska

• a.a Hygiene and Process Support Manager

  • May 2022 - Jun 2023

  Gdańsk, Woj. Pomorskie, Polska The most important duties: - Building an efficient team, providing the necessary knowledge, training and mentoring; - Resource management and the execution of production in accordance with the production plan and internal procedures; - Coordinating the identification of problems and the implementation of corrective action plans; - Preparation of documentation necessary for maintaining required hygiene level in production areas, in accordance with the internal quality system and… Show more The most important duties: - Building an efficient team, providing the necessary knowledge, training and mentoring; - Resource management and the execution of production in accordance with the production plan and internal procedures; - Coordinating the identification of problems and the implementation of corrective action plans; - Preparation of documentation necessary for maintaining required hygiene level in production areas, in accordance with the internal quality system and regulatory requirements such as EMEA/ FDA; - Responsibility for the budget of a subordinate department;

• Drug Product Specialist

  • Mar 2019 - May 2022

  Gdańsk, Woj. Pomorskie, Polska The most important duties: - Active participation in the implementation of FAT (Factory Acceptance Test), SAT (Site Acceptance Test) and IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification). - Participation in the implementation of the SAP system - Preparation of procedural documents and initiating CAPA and Change Control - Chairing regular meetings with production operators to arrange an action plan and assist in problem solving. -… Show more The most important duties: - Active participation in the implementation of FAT (Factory Acceptance Test), SAT (Site Acceptance Test) and IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification). - Participation in the implementation of the SAP system - Preparation of procedural documents and initiating CAPA and Change Control - Chairing regular meetings with production operators to arrange an action plan and assist in problem solving. - Presenting KPIs (Key Performance Indicators) - Maintaining cross-functional communication with other departments - Creating and updating process documentation - Work in clean rooms, class D, C, B - Operating and controlling parameters on process devices such as: Filling line (RABS) for filling syringes and vials, Autoclave, freeze dryer - Visual inspection of the finished product (vials and syringes)



Regeneron Pharmaceuticals, Inc.

• Biotech Production Specialist Aseptic

  • Apr 2018 - Feb 2019

  County Limerick, Ireland The most important duties: - Working on mammalian cell culture (Chinese Hamster Ovary Cells) - Tasks in the field of bioreactor cultivation - Documentation of the drug process - Data input using computer systems (LIMS, QUMAS, OPM, ORACLE, SAP) - Manufacturing equipment support (UV Spektrofotometer, NOVAflex, p / h conductivity meters, cell counte, peristaltic pump, sealers) - Downloading Quality Control samples during the process - Working with liquid nitrogen -… Show more The most important duties: - Working on mammalian cell culture (Chinese Hamster Ovary Cells) - Tasks in the field of bioreactor cultivation - Documentation of the drug process - Data input using computer systems (LIMS, QUMAS, OPM, ORACLE, SAP) - Manufacturing equipment support (UV Spektrofotometer, NOVAflex, p / h conductivity meters, cell counte, peristaltic pump, sealers) - Downloading Quality Control samples during the process - Working with liquid nitrogen - Initiating and implementing CAPA, KKZ. - Participation in activities related to equipment commissioning and validation - Collection and analysis of data generated during the process - Work in clean rooms in class D, C, - Work in a laminar chamber

• Manufacturing Support Technician II

  • Jan 2018 - Apr 2018

  County Limerick, Ireland The most important duties: - Support of production specialists during the process - Organization of deliveries and disinfection of raw materials intended for use in the process - Submission of material requirements using the OPM (Oracle Process Manufacturing Inventory System) - Cleaning equipment used in clean rooms in accordance with approved procedures (SOP's)

• Cleaning Technician I

  • Aug 2015 - Dec 2017

  County Limerick, Ireland