The successful candidate will join 3PBiovian as a Technical Services Technician.
Main responsibilities:
- 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 Validation activities in accordance with the in-force SOPs.
Specifically:
- Prepare and execute protocols related to Tech Transfer policies within a biotech industry, including transfers from customer to facility and between departments.
- Evaluate technical documentation of potential processes for transfer.
- Follow up on Tech Transfer runs and Scale-Up batches to ensure proper performance; prepare Tech Transfer reports.
- Prepare and execute Cleaning, Process, and Analytical Validation Protocols.
- Coordinate the execution of Validation Campaigns.
- Lead risk analysis sessions using HAZOP/FMEA methodologies.
- Prepare URS for equipment needed for specific projects and manage related internal documentation.
- Ensure compliance with GMP regulations.
Assessment criteria:
- Bachelor’s degree in Science, Chemical Engineering, or related discipline.
- At least 5 years of experience in biotech tech transfer activities, including internal and external processes.
- Minimum 5 years in process validation and cleaning validation, preferably in biotech.
- Experience with risk analysis and HAZOP/FMEA methodologies.
- Expertise in GMP regulations.
- Fluent in English.
Why 3PBiovian?
- 26 paid days off (vacation, personal, company days).
- Flexible compensation plan for various benefits.
- Exclusive discounts through our benefits club.
- Flexible hours and reduced workday on Fridays.
- Summer workday reduction in July and August.
- Personalized Learning & Development programs.
- Focus on internal talent, growth, and stable employment.
- Participation in solidarity and health initiatives.
- Flat hierarchies and quick decision-making processes.
- Relocation support for non-resident hires.
Why us?
We are committed to manufacturing advanced medicines with passionate people. We specialize in process development and cGMP manufacturing of biologics and cell therapies, supporting clients throughout their biologics journey, from development to commercial production. We focus on biotech applications in human and animal health, providing tailored solutions to meet client needs. As a leading global CDMO, we aim to improve lives through our work.