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Process Engineer

2 months ago

Maryland, United States Barrington James Full time
Process Engineer

Barrington James is partnering with a leading CRO to find a skilled Process Engineer to join their team. As a key member of the team, you will be responsible for the technical execution of GLP and Non-GLP studies, including preparing virus assay workbooks, managing Sponsor/Client materials, and collaborating with on-site Sponsors/Clients and team members.

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.
Requirements:
  • 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.