Single-Use Technology / Material Qualification Engineer (SUT) JD815723
This individual will complete a gap analysis between the required manufacturing needs and ensure alignment of these needs with the User Requirements Specification.
Review data and technical specifications for each Single-Use Technology (SUT) that is available either from the vendor or through other means to ensure the component is suitable for its intended function as needed by the client.
Manage the SUT vendors, engineering, materials manufacturing throughout introduction of replacement or new SUT equipment.
Experience in review of P&IDs, PFD and assembly of SUT for best use is preferred.
Document the design review of Single-Use (SUT) components and sub-component materials of construction for use within clients GMP manufacturing processes.
Remediate any discrepancies for any single-use technology or component in the event that the SUT specification does not meet the manufacturing specifications.
Bachelors Degree in Science or Engineering or a related field or 2+ years equivalent experience
Experience with upstream and downstream biopharmaceutical facility design.
Knowledge of Good Engineering Practices (GEP) and familiarity with ASME BPE, ASTM E2500 methodology is preferred.
Comfortable in technical interface between Manufacturing, Quality, and Engineering SMEs and Vendors during completion of assessments.