Technical Services Technician

The successful candidate will join 3PBiovian as a Tech Services Technician.

Primary Objective of the position:

• Responsible for the execution of the Tech Transfer Policies of the department according to the in-force SOPs.
• Responsible for the design of process scale-up according to the in-force SOPs.
• Responsible for the execution of the Validation activities in agreement with the in-force SOPs.

Main responsibilities:

• Prepare and execute the protocols corresponding to the Tech Transfer policies in a Biotech industry, not only from customer to facility but also among departments.
• Evaluate the technical documentation of the potential processes to be transferred (Process and analytics).
• Follow up the Tech Transfer runs and Scale-Up batches to assure the right performance of these batches. Prepare the Tech Transfer report.
• Prepare and execute Cleaning, Process and Analytical Validation Protocols.
• Coordinate the execution of the Validation Campaigns.
• Lead the risk analysis sessions following HAZOP/FMEA methodologies.
• Prepare URS’s of the equipment needed for the execution of a certain project as well as the internal documentation for the right management of the equipment.
• Comply and assure the compliance of the GMP regulations.

Assessment criteria:

• Bachelor’s degree in Science, Chemical Engineering, or any other related discipline is required.
• 5 years of experience in tech transfer activities of Biological processes, internal and external tech transfer.
• At least 5 years of experience in process validation and cleaning validation activities, desirable in a biotech company.
• Experience in risk analysis and HAZOP/FMEA methodologies.
• Expert in GMP regulations.
• Fluent in English.