I am partnered with an amazing CRO that are actively looking for a Process Engineer to join their team. You will act as a Study Coordinator, responsible for the technical execution of GLP and Non-GLP studies. This includes preparing virus assay workbooks, managing Sponsor/Client materials, collaborating with on-site Sponsors/Clients and team members, conducting virus assays, analyzing data, and addressing findings from QA audits.
Key Responsibilities:
- Oversee the technology transfer and execution of scaled-down purification process experiments to prepare samples for viral clearance studies, including column chromatography, membrane chromatography, and virus inactivation.
- Support Study Directors in managing Level 3 tasks, focusing on scheduling and resource allocation for viral clearance projects.
- Create and manage tech transfer documentation, including plans and data capture sheets or process/batch records, in collaboration with Sponsors and Clients.
- Execute scaled-down purification process experiments for viral clearance studies on behalf of off-site Sponsors and Clients.
- Complete data capture sheets and process/batch records accurately, ensuring compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), the Code of Federal Regulations (CFR), protocols, and Standard Operating Procedures (SOP).
- May assist with collaborative viral clearance studies by conducting scaled-down purification experiments with on-site Sponsors and Clients.
- Maintain AKTA FPLC systems, including equipment cleaning, proper storage, updating maintenance logs, and coordinating maintenance.
Minimum Qualifications:
- Bachelor’s degree in Biology, Chemistry, Biochemistry, Life Sciences, or Chemical Engineering.
- At least 5 years of relevant experience with column chromatography, tangential flow filtration (TFF), and nanofiltration/virus filtration.
- Proficient with Cytiva AKTA platforms and Unicorn software.
- Experience in Downstream Process Development.
- Familiarity with Column Packing.
- Knowledge of Viral Clearance concepts and studies.
