USP Microbial Plant Specialist

For our USP Department we are looking for a USP Microbial Plant Specialist. In this position you will actively participate in the technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnology products. You will participate in the manufacturing of biotechnology products in accordance with cGMP principles and will do this in accordance with European and FDA requirements.

• Supporting process transfers and validation activities in production scale;
• Supporting qualification and validation activities;
• Assisting with day-to-day efficient operation of Microbial Manufacturing Plant;
• Analysing production processes and schedules to identify opportunities for improving coordination of production, quality and shipping;
• Close cooperation with the MSAT, R&D and Quality Department;
• Liaising with Production Management to assess progress towards production schedules and need for changes that could result from environmental assessment;
• Summarising data generated during production batches, provide reports to Microbial Production Managers and taking part in investigations;
• Regularly presenting data, challenges, proposals and plans to Microbial Production Managers;
• Regularly meeting with Operators to plan activities and support problem solving, conducting trainings;
• Ensuring raw material supply is in planned and ready for any process, in cooperation with Supply Chain Manager;
• Supporting generation and continuous improvement of documentation.

• Higher education in biotechnology, chemical engineering, biology or related;
• 2 years of experience in USP biotechnology or pharmaceutical industry;
• Hands-on experience with USP processes;
• Good knowledge of off-line, at-line and on-line techniques for process monitoring;
• Good understanding of microbial cultivation process control and microbial metabolism;
• GMP experience gained in pilot or full-scale manufacturing plant;
• Experience in keeping and reviewing process and project documentation according to GMP requirements;
• Fluency in English, knowledge of Polish language will be of advantage;
• Good communication skills;
• Good learning skills with flexible attitude to work;
• Ability to work on shifts.