Lead Process Technology Engineer – Pharma Manufacturing

CSL; Broadmeadows; Presencial; AUD 140.000 - 190.000; Jornada completa

Descripción de la vacante

CSL Behring is seeking a Principal PT Engineer to own the definition and governance of process requirements for system design and build on capital projects, OPEX, and BAU activities. You will leverage technology transfer data to drive cross-functional assessments and ensure alignment with quality and regulatory standards.

Join CSL Behring at Broadmeadows as part of a global biotherapeutics leader, contributing to new manufacturing facilities and onshore product development opportunities.

Formación

• Bachelor’s degree in engineering or science with 5+ years in Process Engineering.
• Strong knowledge of cGMP in FDA-regulated environments.
• Technical expertise in complex pharmaceutical processes.
• Understanding of project management principles and leading process improvements.
• Experience working in regulated environments and collaborating cross-functionally.
• Proven ability to lead cross-functional, multicultural, and international teams.

Responsabilidades

• Lead end-to-end development and maintenance of process requirements for system design/build.
• Translate technology transfer inputs into measurable, traceable requirements.
• Establish requirement baselines, version control, and change management.
• Facilitate and document risk assessments, FMEAs, and process hazard analyses.
• Ensure alignment with quality, regulatory, and engineering standards.
• Partner with design, manufacturing, QA/RA, and operations to close gaps and resolve issues.
• Define acceptance criteria and verification/validation approaches for process requirements.
• Monitor process performance, collect feedback, and drive continuous improvement.
• Provide governance via reviews, audits, and training on requirements management.

Conocimientos

Process Engineering

cGMP knowledge

Project management

Cross-functional leadership

Regulatory submission

Educación

Bachelor's degree in engineering

Descripción del empleo

CSL Behring is seeking a Principal PT Engineer to own the definition and governance of process requirements for system design and build on capital projects, OPEX, and BAU activities. You will leverage technology transfer data to drive cross-functional assessments and ensure alignment with quality and regulatory standards.

Join CSL Behring at Broadmeadows as part of a global biotherapeutics leader, contributing to new manufacturing facilities and onshore product development opportunities.