C&Q and Material Manager - contractor (hybrid job)

Summary The C&Q and Material Manager will be responsible for the full lifecycle support of a new filling line and its ancillary equipment, from design through Commissioning and Qualification (C&Q), also manage the commodities and logistics for this project in Hillsboro, Oregon, USA. Responsibilities Material Management Act as the single point of contact (SPoC) for Cascadia project test materials (for Filling, Inspection, Device Assembly, and Packaging processes) Maintain and update dates and quantities in the AirTable tracking tool Place and track orders in MyBuy, including follow-ups on status and pre-approval confirmations (especially for EU-US shipments) Coordinate logistics and shipments, including warehouse requests (via WBS) and inter-vendor transfers (EU and US). Manage supplier interactions (test materials), including offers, quantities, and specification confirmations with global and local packaging teams Coordinate with machine suppliers to confirm delivery timelines and track delivery status Oversee warehouse operations, including stock visibility and reuse of available test materials Ensure compliance with FST (International Trade Affairs and Customs) for US-bound shipments Manage tax and delivery conditions in coordination with relevant departments Proactively address and resolve potential delivery delays (solution oriented) Design Support Participate in the design review process to ensure the new filling line and ancillary equipment are integrated seamlessly with existing utility and process systems at the Hillsboro site. Provide process engineering expertise to ensure design specifications meet manufacturing requirements as needed. Ensure all new components, including process piping and hosing, meet material compatibility and integrity standards. Installation Oversight Provide engineering oversight during the physical installation of the new filling line and ancillary equipment. Coordinate with internal teams (e.g., Automation/IT, Facilities) to ensure the physical and logical integration of the new equipment into the Hillsboro infrastructure, including shared Blueprint network infrastructure and specialized automation systems (e.g., DeltaV, SCADA). Liaise with vendors and contractors, ensuring strict adherence to site safety protocols. Commissioning and Qualification (C&Q) Develop, author, and execute C&Q protocols (IQ/OQ/PQ) for the new filling line, focusing on aseptic processing and clean room standards, which require redundant power, cooling, and high business continuity importance. Collaborate with Quality Assurance (QA) to ensure all C&Q documentation supports the Provisional and Final Release for GMP use of controlled classified areas. Prepare and manage Planned Event (PE) records and Change Control documentation for the project, ensuring all revisions and updates are submitted to the HTO Change Control team and reviewed by the CAPA Review Board (CRB) as necessary. Travel to equipment vendor sites as needed per the project schedule, including but not limited to Site Acceptance Tests (SATs), ensuring all business-related travel costs (accommodation, airfare, meals) are coded to the employee's home functional cost center. Work Methodology Professional services contract Full time job Administrative shift, wiling to support non admin. hours Hybrid work methodology 50/50 Duration: 6 to 12 months with potential extension Location: Hillsboro, Oregon-US