Senior Process Technology Engineer - Pharma Manufacturing

CSL; Melbourne; On-site; AUD 150,000 - 210,000; Full time

Job summary

CSL Limited is a global biopharmaceutical leader expanding its Australian manufacturing operations to support global growth. The Principal Process Technology Engineer will own end-to-end development and governance of process requirements for system design/build within Tier 1–3 capital projects and BAU activities.

The role requires a Bachelor’s degree in engineering or science and 5+ years in Process Engineering, with strong cGMP knowledge, validation experience, and a track record of

Qualifications

• Bachelor’s degree in engineering or science with 5+ years' experience in Process Engineering.
• Strong knowledge of cGMP requirements in FDA-regulated environments.
• Experience with validation activities and facility regulatory submissions.

Responsibilities

• Lead end-to-end development and maintenance of process requirements for system design/build.
• Translate inputs into measurable, traceable requirements.
• Establish baselines, version control, and change management.
• Facilitate 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.
• Monitor process performance and drive continuous improvement.
• Provide governance via reviews, audits, and training on requirements management.

Skills

Process engineering

Regulatory knowledge (cGMP)

Validation

Project management

Cross-functional collaboration

Education

Bachelor’s degree in engineering or science

Job description

CSL Limited is a global biopharmaceutical leader expanding its Australian manufacturing operations to support global growth. The Principal Process Technology Engineer will own end-to-end development and governance of process requirements for system design/build within Tier 1–3 capital projects and BAU activities.

The role requires a Bachelor’s degree in engineering or science and 5+ years in Process Engineering, with strong cGMP knowledge, validation experience, and a track record of