The Principal Process Technology (PT) Engineer is responsible for applying fundamental engineering knowledge for the design and implementation of new process technology as part of our high priority projects. Working on Capital Projects (Tier 1,2 and 3), OPEX projects and BAU activities, the Principal PT Engineer will be part of a project organization and reporting into this project organization.

Own the definition, documentation, and governance of process requirements for system design and build. Leverage inputs—including technology transfer data—to derive clear, testable requirements, and apply them to drive cross-functional assessments (e.g., risk, readiness, and compliance).

The Role

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

To be successful

- Bachelor’s degree in engineering or science (or a related field),



with 5+ years’ experience in Process Engineering, preferably within pharmaceutical manufacturing or pharmaceutical operations.
- Strong knowledge of cGMP requirements and manufacturing operations in FDA-regulated environments, including experience with validation activities and facility regulatory submission requirements.
- Demonstrated technical expertise in complex pharmaceutical processes and technologies, with excellent engineering problem-solving skills and a proven ability to drive effective engineering solutions.
- Understanding of project management principles and a track record of leading process improvements, implementing corrective actions, and delivering positive operational outcomes.
- Experience working in regulated environments and collaborating cross-functionally to investigate issues, identify opportunities, and drive successful resolutions.
- Proven ability to lead and influence cross-functional, multicultural, and international teams, while building effective partnerships and engaging stakeholders to achieve agreed business and enterprise objectives.
- Experience with aseptic filling operations and associated technologies, including process design, technology transfer, validation, contamination control strategies, and regulatory requirements within a GMP manufacturing workplace.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit

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📌 Principal Engineer, Tech Ops (City of Hume)
🏢 CSL
📍 City of Hume