Senior Process Technology Engineer
The Senior Process Technology Engineer plays a key role in the design, implementation, and optimisation of process technologies supporting strategic capital projects, operational excellence initiatives, and business-as-usual activities. Working within a multidisciplinary project environment, this role is responsible for defining, governing, and maintaining process requirements throughout the project lifecycle, ensuring alignment with quality, regulatory, manufacturing, and engineering standards.
Responsibilities
* Lead the development, documentation, and lifecycle management of process requirements for new and existing process technologies.
* Translate technology transfer data and business needs into clear, measurable, and traceable process requirements that support system design and implementation.
* Establish and maintain requirement governance, baseline management, version control, and change management processes.
* Facilitate risk assessments, process hazard analyses, and FMEA activities to identify and mitigate operational and compliance risks.
* Partner with Manufacturing, Engineering, Quality, Validation, Technical Transfer, Regulatory Affairs, and other stakeholders to resolve issues and ensure project success.
* Define and support verification, validation, and acceptance criteria to ensure process requirements are effectively implemented and compliant.
Qualifications
* Bachelor's degree in engineering, science, or a related technical discipline.
* Minimum 5 years of experience in process engineering within pharmaceutical, biotechnology, or other regulated manufacturing environments.
* Strong knowledge of cGMP requirements, manufacturing operations, and regulatory expectations within FDA-regulated facilities.
* Demonstrated experience leading process improvement initiatives, complex technical investigations, and cross‐functional project activities.
* Proven ability to collaborate effectively across multidisciplinary, multicultural, and international teams while delivering practical engineering solutions.
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 https://www.csl.com/accessibility-statement. CSL Global Privacy Notice for Job Applicants and Candidates.
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