Bulk Senior Principal Process Engineer

Position Purpose:

Reporting to the Horizon 2 Process Area System Owner, this FTE role provides long-term technical and system ownership for bulk purification 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 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. 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 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.

Position Requirements

• Education:
  Bachelor’s degree required in an Engineering or Science discipline.
  
• Travel: 25-30% Ability and willingness to travel domestically and internationally as required to support equipment vendor activities, including Factory Acceptance Testing (FAT).

Experience:

• 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 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. Inspection support experience is preferred.
• Demonstrated 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.

The expected base salary range for this position at hiring is $135,000 - $160,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.