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The successful candidate will join 3 PBiovian as a Technical Services Technician .
Main responsibilities:
* Responsible for executing the Tech Transfer Policies of the department according to the current SOPs.
* Designing process scale-up procedures in line with SOPs.
* Executing Validation activities in accordance with SOPs, including preparing and executing protocols for Tech Transfer, Process, and Analytical Validation.
* Evaluating technical documentation for potential process transfers.
* Monitoring Tech Transfer runs and Scale-Up batches to ensure proper performance, and preparing related reports.
* Coordinating Validation Campaigns and leading risk analysis sessions using HAZOP/FMEA methodologies.
* Preparing URS for equipment and managing internal documentation for equipment handling.
* Ensuring compliance with GMP regulations.
Assessment criteria:
* Bachelor’s degree in Science, Chemical Engineering, or related discipline.
* Minimum 5 years of experience in biotech tech transfer activities and process validation.
* Experience with risk analysis, HAZOP/FMEA methodologies, and GMP regulations.
* Fluent in English.
Why 3 PBiovian?
We offer competitive benefits including 26 paid days off, flexible compensation plans, exclusive discounts, flexible working hours, and initiatives promoting employee well-being and professional growth.
Why us?
We are a global CDMO specializing in process development and GMP manufacturing of biologics and cell therapies, committed to supporting your biologics journey from development to delivery.
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