Requirements: English
Company: Prothya Biosolutions
Region: Amsterdam , North Holland
Purpose of the Job: As a Senior Engineering Specialist, you will act as the process and technical specialist for our lyophilization and filling processes. You are responsible for troubleshooting, optimizing, development and validation of the freeze dryers and filling lines, in close collaboration with Production, Technical Engineering, and QA/Validation stakeholders. In this role, you are capable of acting as the SME in several multidisciplinary projects, providing strategic technical guidance, and ensuring compliance with national and international quality standards.
Key Accountabilities:
- Identifying and solving process or technical issues arising during routine production.
- Providing key input for all changes related to Freeze Driers and Filling lines.
- Monitoring and interpreting regulatory developments and industry trends, and translating these into process improvements.
- Developing and implementing SOPs and production documentation based on industry standards and requirements (e.g., EU GMP Annex I).
Required Background:
- Master''s degree in Chemical Engineering, Biomedical Engineering, or a similar discipline.
- Over 5 years of experience in the pharmaceutical industry in a similar role.
- Solid knowledge of Aseptic filling and Lyophilization and proven experience therein.
- Solid knowledge of process validation and proven experience therein.
- Knowledge of up-to-date industry guidelines.
- Knowledge of airflow visualization studies is a plus.
Personal Characteristics:
- Flexible and energetic, with strong perseverance.
- Capable of handling a dynamic environment with changing priorities.
- Hands-on, present on the shop floor when needed.
Challenges:
- Able to find pragmatic solutions within time and budget constraints.
- Capable of following production priorities and understanding the bigger picture.
Expectations:
- Ready to make an immediate impact.
Our Offer:
- A full-time position with a competitive salary.
- A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
- Flexible working hours, subject to agreement.
- Personal training budget of 2,100 every 3 years.
- Contribution to travel expenses from the first kilometer.
- Good accessibility by public transport, with private parking options available.
- Pension plan with Zorg Welzijn