Description:
Join a forward-thinking team dedicated to innovation in the biotech industry. This dynamic environment focuses on optimizing processes to ensure high-quality production and regulatory compliance.
We are looking for a skilled Process Engineer with strong technical expertise and problem-solving abilities. If you are passionate about process development and optimization and thrive in a collaborative setting, this role could be your next exciting opportunity.
This role requires a willingness to travel to follow up on equipment fabrication and testing phases.
* You oversee the fabrication of bioreactors and quality tanks, ensuring smooth follow-up on manufacturing and FAT processes (willingness to travel required).
* You collaborate with cross-functional teams to conduct FAT/SAT and document all required testing in relevant protocols and reports.
* You translate User Requirement Specifications (URS) into Functional Design Specifications (FDS) alongside the Project Manager.
* You review and draft P&IDs, perform final reviews with end users, and ensure design alignment.
* You support procurement activities and review welding books to guarantee quality and compliance.
* You focus on CIP/SIP cycle validation and IO testing to ensure process integrity.
* You assist in developing basic recipes with users to prepare the environment for final recipe implementation.
* You ensure all processes comply with regulatory requirements and cGMP industry standards.
Requirements
* You hold a Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
* You have 5-10 years of relevant experience in downstream equipment design in the biotech or pharmaceutical industry.
* You possess strong analytical and problem-solving skills.
* You are proficient in bioreactor operation and familiar with regulatory guidelines (e.g., GMP).
* You have experience with (single-use) purification equipment, columns, and supporting equipment.
* You possess upstream experience with (single-use) bioreactors and continuous/perfusion culture systems, along with knowledge of centrifugation/filtration technologies.
* You have knowledge of automation systems such as Delta V, PI historian, and MES systems.
* You demonstrate strong communication and teamwork abilities.
* You are proficient in English.