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.
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