The successful candidate will join 3PBiovian 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 accordance with SOPs.
- Executing validation activities following SOPs.
Specific duties:
- Prepare and execute protocols for Tech Transfer in a biotech environment, including inter-departmental transfers.
- Evaluate technical documentation for potential process transfers.
- Monitor Tech Transfer runs and scale-up batches, ensuring performance standards; prepare related reports.
- Develop and execute validation protocols for cleaning, processes, and analytics.
- Coordinate validation campaigns.
- Lead risk analysis sessions using HAZOP and FMEA methodologies.
- Prepare URS for equipment and manage internal documentation for equipment management.
- Ensure compliance with GMP regulations.
Assessment criteria:
- Bachelor’s degree in Science, Chemical Engineering, or related field.
- Minimum of 5 years’ experience in biotech tech transfer activities.
- At least 5 years’ experience in process and cleaning validation, preferably in biotech.
- Experience with risk analysis and HAZOP/FMEA methodologies.
- Expertise in GMP regulations.
Benefits and company culture:
- 26 paid days off including vacation and personal days.
- Flexible compensation plan for exempt expenses.
- Exclusive discounts through company benefits club.
- Flexible working hours with reduced hours on Fridays and summer schedule.
- Professional growth opportunities through personalized Learning & Development programs.
- Supportive environment focusing on internal talent and stability.
- Participation in community and wellness programs.
- Flat hierarchies facilitating quick decision-making.
- Relocation support for non-local hires.
Why choose us?
We are committed to manufacturing advanced medicines with passionate people. Specializing in biologics and cell therapy, we support our clients throughout their biologics journey from development to delivery. As a leading global CDMO, we focus on personalized solutions to improve lives.