Production Technician (Fixed-Term)

Major accountabilities:

• Responsible for the control of Raw Materials (MP) for the manufacturing of the sterile batch (e.g. labels, shelf-life, compliance with BR).
• Prepare in the Sterile Area product bulk solutions and set up the machine for filling, stoppering and crimping vials, execute production activities in Sterile Area, according to the Batch Record instructions aseptic behavior instructions and SOPs, Label and package the products.
• Participate in the Media Fill execution
• Observe behavioral standards and flow of materials in the areas with controlled contamination (and with regard to the sterile room) in compliance with the internal procedures.
• Sterilize in an autoclave and dry caps and capsules in the oven according to the internal procedures; de-aerate flasks and glassware in the oven to be used in the subsequent processing phases.
• Perform cleaning and washing of the glassware and bottles to be used in the subsequent processing steps in accordance with the procedures laid down by the specific procedures.
• Perform visual inspection, manually and using the semi-automatic screamer machine.
• Keep track in a timely manner of all the activities performed during the manufacturing process, as per Data Integrity, SOPs instruction and GMP requirements.
• Support maintenance department during ordinary and extraordinary maintenance activities.
• Referent of aseptic process for the improvement of the production lines.

Essential requirements:

• Scientific technical degree.
• Previous experience in a similar role within a highly regulated environment (ideally GMP).
• Fluent in Italian. Basic knowledge of English.
• Detail oriented.