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Process Engineer II
Ref No.: 18-16037
Location: Hillsboro, Oregon
Process Engineer II
Onsite in Hillsborough, OR
12 Month Contract
W2 Only

A new product is being transferred to Hillsboro Technical Operations (HTO) Liquid Fill Line 1.
-To enable this transfer, a new 15cc container closure format will be introduced to the Filling Line in support of timely execution of tech transfer activities.
-The Process Engineer will provide support to a Tech Transfer Project, as well as the MSAT Process
-Engineering Department, specifically accountable for supporting process development and equipment/system qualification activities. The focus will be on systems and equipment associated with Drug Product operations (e.g. formulation, vial handling/filling, CIP/SIP). Success in these areas will depend upon the individual's ability to effectively lead, collaborate and communicate with team members.
Job Accountabilities:
-Cycle Development and Performance Qualification of DP Process Equipment, including but not limited to:
-Vial Washing Machine
-Vial Depyrogenation Tunnel
-Vial Filling Machine and Time/Pressure Filling System
-Filling Isolator
-Vial Capping Machine
-Formulation Tanks
-Development, Review and Approval of Cycle Development and Validation Protocols.
-Planning and execution of studies/protocols on the manufacturing systems, including coordination with supporting departments to ensure material and resource availability.
-Complete end to end process of any discrepancies or deviations resulting from executed protocols.
-Development and post-approval of necessary Summary Reports.
-Create and manage Change Records in Trackwise to support project execution.
-Participate in Risk Assessment activities and support Root Cause Evaluation for deviations.
-Support product-specific process and recipe development activities, including characterization and engineering runs.

-The Process Engineer will provide technical knowledge and support to other Process Engineers in support of Tech Transfer activities.
-Candidate must have a demonstrated record of competencies that match the proposed activities. Skills include:
Teamwork & Collaboration
Technical Knowledge with experience in Drug Product Manufacturing (ideally liquid vial filling)
Good Communication (Verbal and Written)
Technical Writing proficiency
Self-starter, able to execute work with limited direction
Flexibility to support nights and weekend work during key project execution windows