Biotechnologist Trainee position at Lonza, responsible for the manufacture of therapeutic proteins under cGMP conditions. Expectations include performing equipment monitoring, basic laboratory tasks, and routine sanitization tasks. The position reports to the Senior/Section Lead/Manager of the Manufacturing Large Scale, Small Scale or Centralized Operations Team.
Requirements
- Learn and perform well-defined procedures within a GMP manufacturing setting
- Perform equipment monitoring & and basic 6S housekeeping
- Perform basic laboratory tasks (e.g. sampling, pH/conductivity/osmolality measurements etc.)
- Perform routine sanitization tasks to maintain facility standards
- Trained & signed off on Performance Measures (PMs) relating to CIP/SIP/basic tank & instrument operations
- Demonstrate aseptic technique in the handling of product/ materials
- Perform basic process & equipment troubleshooting
- Multi-task on equipment preparations & operations to ensure adherence to schedule
- Attain full competency in the performance of all operations relevant to manufacturing areas assigned.
- Display basic process & equipment troubleshooting ability under routine scenarios.
- Become a technical process expert by exhibiting basic understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
- Use Standard Operating Procedures (SOPs), logbooks & Batch Records (BRs) effectively & competently
- Submit samples via Laboratory Information Management System (LIMS)
- Materials & Equipment Preparations
- Able to identify the correct materials by part number and FEFO lots.
- Select appropriate Dispensing Booths/Hoods and Weight balance.
- Identify sampling requirements based on material RMS.
- Assemble Autoclave assembly per SOP.
- Able to perform equipment wash without stains and residues.
- Solutions Preparations
- Enhanced knowledge of the different setup and equipment use between customers for different operations, e.g.: CIPs and buffer/media transfer
- Able to identify and lead the installation of the different set up and equipment for different customers for different operations, e.g.: CIPs and buffer/media transfer
- Understand the criticality of setting up the right path and equipment for different customers
- In depth knowledge of the different set up and the equipment use between single use and the conventional stainless steel equipment
- Able to formulate plans for executing CIPs to meet different customers requirement, e.g., the CIPs of the HTST.
Benefits