Biopharma Process Engineer: Design & Commissioning

Biotech Engineering; Melbourne; On-site; AUD 110,000 - 165,000; Full time

Job summary

Biotech Engineering is seeking a Process Engineer based at our Port Melbourne facility to plan, design, and commission biotech and advanced chemical production lines. You will translate manufacturing specs into scalable systems and own plant layout, PFDs, and P&IDs in compliance with cGMP and safety standards.

Responsibilities include coordinating with fabrication teams, leading FAT/SAT/IQ-OQ testing, and optimizing processes for reliability and efficiency.

Qualifications

• Master’s degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, or closely related field.
• 1–3+ years of practical engineering experience in pharma/ biotech/ chemical or advanced manufacturing environments.
• Proficient in 2D/3D CAD software (AutoCAD, SolidWorks) and process-flow modeling tools.
• Solid understanding of fluid handling systems, pumps, piping, sanitary design.
• Familiarity with GMP, ISO, TGA regulations.
• Strong field troubleshooting and on-site problem-solving abilities.
• Clear technical documentation and client-facing communication skills.

Responsibilities

• Production Plant & Line Design: formulate layout, PFDs, and P&IDs for pharma/biotech facilities.
• Machinery & Equipment Specification: draft specs for mechanical equipment, filtration skids, pumps, valves, bioreactors, packaging/filling machinery.
• Fabrication & Construction Coordination: coordinate with fabricators and installers to meet tolerances and designs.
• Testing, Commissioning & Quality Verification: lead FAT, SAT, IQ/OQ and optimize production parameters.
• Process Optimization & Maintenance Procedures: establish preventive maintenance schedules and SOPs.
• Technical Documentation & Compliance Handover: prepare commissioning reports and compliance dossiers.

Skills

CAD proficiency

Process flow modeling

Troubleshooting on-site

Technical documentation

Education

Master’s degree in Biomedical/ Chemical/ Mechanical Engineering

Tools

AutoCAD

SolidWorks

Job description

Biotech Engineering is seeking a Process Engineer based at our Port Melbourne facility to plan, design, and commission biotech and advanced chemical production lines. You will translate manufacturing specs into scalable systems and own plant layout, PFDs, and P&IDs in compliance with cGMP and safety standards.

Responsibilities include coordinating with fabrication teams, leading FAT/SAT/IQ-OQ testing, and optimizing processes for reliability and efficiency.