Senior Principal Bulk Purification Engineer

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

Job summary

CSL is seeking a Senior Process Engineer to own bulk purification systems at the Kankakee site in Illinois. The role drives design, qualification, and lifecycle ownership for chromatography, filtration, and single-use systems within US Ig Expansion programs.

You will lead cross-functional reviews, manage vendor interfaces, and ensure cGMP compliance from concept through handover. Travel 25–30% is required to FAT/SAT and project locations.

Qualifications

• Bachelor’s degree in Engineering or Science.
• Travel: 25-30% domestically and internationally.
• Minimum 7+ years of pharma/biotech process engineering with protein purification expertise.

Responsibilities

• Own assigned process and equipment systems across the full lifecycle.
• Translate needs into technical specs and acceptance criteria.
• Provide technical leadership during design reviews, FAT/SAT, and commissioning.
• Coordinate interfaces among internal functions and vendors.
• Plan vendor document reviews, qualification, and turnover.
• Support GxP deliverables including URS, DQ, and validation documentation.
• Lead deviations, CAPAs, change controls, and regulatory commitments.
• Support process characterization, PPQ readiness, and continued verification.
• Ensure sustainable site ownership with procedures, training, and maintenance strategies.
• Manage risks, issues, and project status with governance input.
• Lead capital and process-improvement initiatives for safety and reliability.
• Represent MS&T in cross-functional forums and mentor staff.

Skills

Protein purification

Chromatography

Depth filtration

Ultrafiltration

Virus inactivation

Virus filtration

Nanofiltration

Column packing

Filter integrity testing

Single-use systems

GxP knowledge

Education

Bachelor’s degree in Engineering or Science

Tools

ASME BPE

ISO 2038

ISO 2852

Job description

CSL is seeking a Senior Process Engineer to own bulk purification systems at the Kankakee site in Illinois. The role drives design, qualification, and lifecycle ownership for chromatography, filtration, and single-use systems within US Ig Expansion programs.

You will lead cross-functional reviews, manage vendor interfaces, and ensure cGMP compliance from concept through handover. Travel 25–30% is required to FAT/SAT and project locations.