Position Purpose:
Reporting to the Horizon 2 Process Area System Owner, this FTE role provides long-term technical and system ownership for plasma pooling, thawing, bottle opening, and centrifugation processes and equipment supporting the US Ig Expansion program and the Kankakee manufacturing site. The position ensures process and equipment requirements are translated into compliant, operable, maintainable, and reliable designs and remain effective through design, installation, commissioning, qualification, process performance qualification, operational handover, and routine operation.
The role serves as the subject matter expert for PTC (Pooling, Thawing, Centrifugation) unit operations, including thawing water baths, automated bottle opening, pooling and transfer systems, pooling robotics, centrifugation, parts washers, and associated ancillary systems. The engineer provides technical leadership for scope definition, design reviews, vendor coordination, FAT/SAT, commissioning and qualification support, technical issue resolution, change control, deviation and CAPA support, process validation, continued process verification, lifecycle improvements, and knowledge transfer to site operations. The position works cross-functionally with Engineering, Automation, CQV, Validation, Tech Transfer, Quality, Regulatory, Production, Maintenance, Procurement, Construction, and external design and equipment partners.
The position requires periodic business travel to equipment vendors and other project locations, primarily to support Factory Acceptance Testing (FAT), technical reviews, and other project execution activities.
Reporting Relationships:
This position reports to the Horizon 2 Process Area System Owner.
Reporting to this position: N/A
Principal Accountabilities:
Own assigned process and equipment systems across the full lifecycle, from concept and design through commissioning, qualification, process validation, operational handover, routine operation, and continuous improvement.
Translate process, product, regulatory, operational, maintenance, and safety needs into user requirements, technical specifications, system risk assessments, design criteria, and acceptance requirements.
Provide technical leadership and documented owner input during process, equipment, piping, automation, facility-interface, constructability, operability, maintainability, contamination-control, and safety reviews.
Coordinate technical interfaces among internal functions, A/E partners, equipment vendors, integrators, and construction/CQV teams; identify gaps, dependencies, and decisions requiring escalation.
Plan and support vendor document reviews, FAT, SAT, commissioning, troubleshooting, qualification, punch-list resolution, turnover, and package closeout for assigned systems.
Own or support GxP and project deliverables, including URS, technical specifications, design documentation, equipment packages, DQ, RTM, validation and tech-transfer strategies, ISA-88/common-language documentation, contamination-control inputs, and engineering turnover packages.
Serve as the process SME for deviations, investigations, CAPAs, change controls, regulatory commitments, inspection support, startup issues, and equipment performance concerns.
Support process characterization, technology transfer, PPQ readiness/execution, continued process verification, and establishment of operating ranges, control strategies, and performance monitoring.
Ensure systems are ready for sustainable site ownership through procedures, training, spare-parts and maintenance strategies, lifecycle documentation, data and alarm review, and knowledge transfer to Operations, Maintenance, Automation, Quality, and MS&T.
Manage technical risks, issues, actions, and deliverable status against the project schedule; communicate clear recommendations, mitigation plans, and decisions through project governance.
Lead complex capital and process-improvement initiatives, apply risk-based decision making, and…