Proclinical are proud to be partnered with our client, an Australian pharmaceutical manufacturing business producing critical medicines for the global market.
Role Overview
Reporting to the Chief Operations Officer, this role sits within an established Process / Projects team and will work closely with Production, Quality, Validation, Product Development, Regulatory Affairs and external suppliers.
The Senior Process Engineer will lead key process engineering projects, including a priority new product introduction project requiring strong experience in liquid manufacturing and processes involving chemical reactions.
This role suits someone who can combine hands‑on process engineering capability with strong project leadership, GMP awareness and the ability to deliver complex projects on time and within budget.
Key Responsibilities
* Lead process engineering projects for new products, equipment, technologies and process improvements.
* Support new product introduction, process scale‑up and optimisation within the existing plant.
* Work with liquid manufacturing processes, including chemical reaction‑based processes.
* Develop User Requirement Specifications for new plant and equipment.
* Evaluate supplier offers and prepare CapEx documentation.
* Support equipment procurement, installation, commissioning, qualification and validation activities.
* Troubleshoot equipment and process issues across manufacturing operations.
* Contribute to SOPs, batch documentation, BMRs, technical reports, qualification documents and CMC / Module 3 packages.
* Partner with Production, Product Development, Technical, Validation and QA teams to achieve business objectives.
* Ensure process changes and improvement projects maintain GMP, WHS, quality and compliance requirements.
Skills and Experience
* Bachelor’s degree in Engineering, ideally Chemical Engineering, Process Engineering or equivalent.
* 6+ years’ experience in pharmaceutical manufacturing or a related process engineering role.
* Strong experience in liquid manufacturing, ideally involving chemical reactions.
* Sterile manufacturing experience highly desirable.
* Demonstrated ability to deliver complex projects on time and within budget.
* Strong understanding of validation requirements across process, plant and equipment.
* Experience with equipment procurement, installation, commissioning and qualification.
* Experience developing or contributing to URS, SOPs, batch records, qualification documentation or technical reports.
* Strong analytical skills and excellent attention to detail.
* Good written and verbal communication skills.
* Ability to build strong working relationships with internal and external stakeholders.
Proclinical Staffing is an equal opportunity employer.
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