Senior Process Technology Engineer - Pharma Manufacturing

Csl Behring; Melbourne; On-site; AUD 120,000 - 150,000; Full time

Job summary

CSL Behring in Australia is seeking a Principal Process Technology Engineer to lead end-to-end development and governance of process requirements for system design and build on capital and BAU projects. The role involves translating inputs into measurable requirements, driving risk assessments, and ensuring compliance with cGMP in FDA-regulated environments.

You will collaborate with design, manufacturing, QA/RA, and operations to close gaps, lead improvements, and support the Broadmeadows

Qualifications

• Bachelor’s degree in engineering or science; 5+ years in Process Engineering.
• Strong knowledge of cGMP and FDA-regulated manufacturing environments.
• Technical expertise in complex pharmaceutical processes and technologies.
• Experience leading process improvements and corrective actions.
• Ability to lead cross-functional, multicultural teams and drive outcomes.
• Experience with regulatory submissions and validated systems.

Responsibilities

• Lead end-to-end development and maintenance of process requirements for system design/build.
• Translate technology transfer and inputs into measurable, traceable requirements.
• Establish requirement baselines, version control, and change management.
• Facilitate risk assessments, FMEAs, and process hazard analyses using requirements.
• 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.

Skills

Process Engineering

cGMP Knowledge

Regulatory Submissions

Cross-functional Collaboration

Problem Solving

Project Leadership

Education

Bachelor’s degree in engineering or science

Job description

CSL Behring in Australia is seeking a Principal Process Technology Engineer to lead end-to-end development and governance of process requirements for system design and build on capital and BAU projects. The role involves translating inputs into measurable requirements, driving risk assessments, and ensuring compliance with cGMP in FDA-regulated environments.

You will collaborate with design, manufacturing, QA/RA, and operations to close gaps, lead improvements, and support the Broadmeadows