Are you looking for an opportunity to develop your professional career in a CDMO Quality Control department?
The successful candidate will join 3PBiovian as a Quality Control Technician - Biology Laboratory.
Main responsibilities :
- Ensure GMP activities in the biological department.
- Evaluate and review technical documentation related to the Quality Control of the Biological area, including analytical results in routine manufacturing, validation, and transfer activities within established timelines.
- Prepare and/or review documentation throughout the analytical QC methods' lifecycle, such as validation, transfer, verification protocols, reports, and change controls, adhering to deadlines.
- Participate actively in project teams, including internal and customer meetings as applicable.
- Review and approve project documentation (Sampling Plans, Flow charts) necessary for operations.
- Draft and supervise Standard Operating Procedures (SOPs).
- Investigate OOTs, OOSs, and deviations.
- Manage CAPAs arising from deviations and verify their effectiveness.
- Support stability studies in collaboration with other technicians and in accordance with customer agreements.
- Provide quality support during production incidents.
Assessment criteria :
- University Degree or equivalent in Chemistry, Pharmacy, Biotechnology, Biochemistry, or related fields.
- Master's degree in a related area is preferred.
- PhD in Biotechnology is valued but not mandatory.
Experience :
- 3 to 4 years in protein analysis, development/qualification/validation of analytical methods, molecular biology techniques for protein characterization, microbiology techniques, working with recombinant proteins, mAbs, Biosimilars, ADCs, and knowledge of pharmaceutical regulatory guidelines.
Languages :
- Proficiency in spoken and written English (Level C1 / Advanced).
Why 3PBiovian?
- 26 paid days off (vacation, personal days, company holidays).
- Flexible compensation plan for personal services.
- Exclusive discounts through our benefits club.
- Flexible working hours and reduced hours during summer Fridays.
- Dedicated Learning & Development programs for career growth.
- Focus on internal talent, upskilling, and stable employment.
- Participation in social responsibility activities.
- Well-being programs including healthy lunches and safe work environments.
- Flat hierarchies and quick decision-making processes.
- Relocation support for candidates outside Navarra.
Why us?
We are committed to manufacturing advanced medicines with passionate people. As a global leader in biologics and cell therapy manufacturing, we support our clients from development to delivery, focusing on biotech in human and animal health sectors. Join us to help improve lives.