Biotech Process Optimization Specialist
il y a 5 jours
About Arcadis
We are a forward-thinking organization dedicated to innovation in the biotech industry. Our dynamic environment focuses on optimizing processes to ensure high-quality production and regulatory compliance.
Job Description
We are seeking a skilled Process Engineer with strong technical expertise and problem-solving abilities to oversee the fabrication of bioreactors and quality tanks, ensuring smooth follow-up on manufacturing and FAT processes. The ideal candidate will collaborate with cross-functional teams to conduct FAT/SAT and document all required testing in relevant protocols and reports.
Key Responsibilities
- You will translate User Requirement Specifications (URS) into Functional Design Specifications (FDS) alongside the Project Manager.
- You will review and draft P&IDs, perform final reviews with end users, and ensure design alignment.
- You will support procurement activities and review welding books to guarantee quality and compliance.
- You will focus on CIP/SIP cycle validation and IO testing to ensure process integrity.
- You will assist in developing basic recipes with users to prepare the environment for final recipe implementation.
- You will 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.
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