Senior Bulk Purification Process Engineer - Lead Projects

CSL; Kankakee (IL); On-site; USD 135,000 - 160,000; Full time

Job summary

CSL Behring is seeking a Process Engineer to provide long-term technical ownership of bulk purification processes and equipment at the Kankakee, IL site. You will oversee chromatography, filtration, virus inactivation, and single-use systems across design, installation, qualification, validation, and handover, collaborating with multiple integration teams.

The role requires 7+ years in pharma/biotech process engineering, cGMP experience, and strong ability to resolve complex technical issues

Qualifications

• Bachelor's degree in Engineering or Science required.
• Experience in pharmaceutical/biotech process engineering or manufacturing science.
• Knowledge of hygienic process equipment and piping design per ASME BPE/ISO standards.
• Experience with cGMP and regulatory environments; inspection support preferred.

Responsibilities

• Own assigned process and equipment systems across the full lifecycle from concept through routine operation and continuous improvement.
• Translate needs into user requirements, technical specs, risk assessments, and acceptance criteria.
• Provide technical leadership during reviews of process, equipment, piping, automation, and safety aspects.
• Coordinate interfaces with internal teams, A/E firms, vendors, and construction/CQV; identify gaps and escalation points.
• Plan and support FAT, SAT, commissioning, qualification, troubleshooting, and turnover for assigned systems.
• Own or support GxP deliverables including URS, specs, design docs, risk assessments, validation, and tech-transfer.
• Serve as SME for deviations, CAPAs, change controls, regulatory commitments, and startup issues.
• Support process characterization, tech transfer, PPQ readiness/execution, and continued process verification.
• Ensure readiness for site ownership with training, maintenance strategies, and lifecycle documentation.
• Manage risks, issues, and deliverables status; communicate recommendations and mitigation plans.
• Lead capital and process-improvement initiatives to enhance safety, compliance, reliability, and cost.

Skills

Protein purification

Chromatography

Depth filtration

Ultrafiltration/Diafiltration

Virus inactivation/filtration

Single-use processing

Lifecycle ownership

Regulatory compliance

Cross-functional leadership

Education

Bachelor's degree in Engineering or Science

Job description

CSL Behring is seeking a Process Engineer to provide long-term technical ownership of bulk purification processes and equipment at the Kankakee, IL site. You will oversee chromatography, filtration, virus inactivation, and single-use systems across design, installation, qualification, validation, and handover, collaborating with multiple integration teams.

The role requires 7+ years in pharma/biotech process engineering, cGMP experience, and strong ability to resolve complex technical issues