PTC Senior Principal Process Engineer

CSL Behring • Kankakee, IL

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About The Position

The Senior Principal Process Engineer is an FTE role that 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. It 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 across 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 role works cross-functionally with Engineering, Automation, CQV, Validation, Tech Transfer, Quality, Regulatory, Production, Maintenance, Procurement, Construction, and external design and equipment partners. Periodic domestic and international business travel is required, primarily to support vendor FATs, technical reviews, and other project execution activities.

The position owns assigned systems through their lifecycle and supports GxP and project deliverables, process characterization and technology transfer, PPQ readiness and execution, sustainable site ownership, and continuous improvement. It also represents Process Technology/MS&T in cross-functional and global forums and mentors engineers, specialists, and site personnel in the assigned process area. The position reports to the Horizon 2 Process Area System Owner; no positions report to it.

Requirements

• Bachelor’s degree in an Engineering or Science discipline.
• At least 7 years of experience in pharmaceutical, biotechnology, plasma-derived product manufacturing, chemical processing, or a comparable regulated manufacturing environment.
• Experience owning or technically leading equipment and process systems through design, vendor execution, FAT/SAT, commissioning, qualification, process validation, operational handover, and lifecycle support.
• Experience developing and reviewing GxP and engineering deliverables, such as user requirements, technical specifications, design documentation, system risk assessments, equipment packages, design qualification, requirements traceability, validation and technology-transfer documentation, and turnover packages.
• Experience with hygienic process equipment and piping design in accordance with ASME BPE, ISO 2037, ISO 2852, and applicable site engineering standards, including cleanability, drainability, dead-leg control, CIP/SIP, materials of construction, automation interfaces, maintainability, and operator-centered design.
• Direct experience in regulated environments, including cGMP and applicable safety and environmental requirements.
• Ability to resolve complex technical issues, assess risk, manage deviations/CAPAs/change controls, and communicate recommendations to technical and nontechnical stakeholders.
• Experience working in cross-functional, multicultural, and international project teams and coordinating A/E firms, equipment vendors, and internal functions.
• Ability and willingness to travel domestically and internationally as required, including to support equipment vendor activities such as FAT.

Nice To Haves

• Technical experience with plasma or biological-material thawing, container opening, liquid pooling and transfer, automated material handling/robotics, centrifugation, and equipment cleaning systems is strongly preferred.
• Inspection support experience is preferred.

Responsibilities

• Own assigned process and equipment systems 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 documented owner input and technical leadership 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 and execution, continued process verification, and establishment of operating ranges, control strategies, and performance monitoring.
• Prepare systems 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 recommendations, mitigation plans, and decisions through project governance.
• Lead complex capital and process-improvement initiatives and identify opportunities to improve safety, compliance, reliability, capacity, yield, cycle time, and cost using risk-based decision making.
• Represent Process Technology/MS&T in cross-functional and global forums and mentor engineers, specialists, and site personnel in the assigned process area.

Benefits

• The role may include incentive compensation and equity in addition to base salary.
• The posting refers candidates to CSL’s benefits information but does not specify individual benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior