PTC 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 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.

The role 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 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:
  Bachelors 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 biotechnology plasma-derived product manufacturing chemical processing or a comparable regulated manufacturing environment.
• 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.
• 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 $135000 - $160000. 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 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.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at Benefits

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

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