Bulk Senior Principal Process Engineer

CSL Behring•Kankakee, IL

About The Position

The Bulk Senior Principal Process Engineer provides long-term technical and system ownership for bulk purification processes and equipment supporting the US Ig Expansion program and the Kankakee manufacturing site. Reporting to the Horizon 2 Process Area System Owner, the engineer ensures that process and equipment requirements are translated into compliant, operable, maintainable, and reliable designs, and that systems remain effective through design, installation, commissioning, qualification, process performance qualification, operational handover, and routine operation. The role serves as the subject matter expert for bulk purification unit operations, including chromatography, ultrafiltration/diafiltration, depth filtration, chemical virus inactivation, virus filtration, column packing, filter integrity testing, and associated single-use assemblies. It provides technical leadership for scope definition, design reviews, vendor coordination, FAT/SAT, commissioning and qualification, 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. It requires periodic domestic and international business travel, primarily for vendor FATs, technical reviews, and other project execution activities. The role mentors engineers, specialists, and site personnel in the assigned process area. The expected base salary range at hiring is $135,000–$160,000; total compensation may also include incentive compensation and equity.

Requirements

Bachelor’s degree in an Engineering or Science discipline.
Minimum 7 years of experience in pharmaceutical or biotechnology process engineering, manufacturing science and technology, or technical operations, with demonstrated expertise in protein purification.
Technical experience with chromatography, depth filtration, ultrafiltration/diafiltration, virus inactivation, virus filtration/nanofiltration, column packing, filter integrity testing, and single-use processing systems.
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, including 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 to support equipment vendor activities, including FAT.

Nice To Haves

Inspection support experience.

Responsibilities

Own assigned process and equipment systems across the 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 subject matter expert 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.
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 recommendations, mitigation plans, and decisions through project governance.
Lead complex capital and process-improvement initiatives, apply risk-based decision making, and identify opportunities to improve safety, compliance, reliability, capacity, yield, cycle time, and cost.
Represent Process Technology/MS&T in cross-functional and global forums and mentor engineers, specialists, and site personnel in the assigned process area.
Travel domestically and internationally as required, including to equipment vendors for FATs, technical reviews, and project execution activities.