Process Engineer

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

Based at our facility in Port Melbourne, we are seeking a dedicated and technicallyproficient Process Engineer to plan, design, integrate, and commission biopharmaceuticaland advanced chemical production plant systems.

Aligned with ANZSCO 233513 (Production or Plant Engineer), this role is responsible fortranslating manufacturing specifications into fully functional, scalable production lines. Youwill take ownership of process plant layout and mechanical/fluidic design, coordinate directlywith fabrication and installation contractors during the build phase, and conduct hands-ontesting, commissioning, and optimization of processing machinery to deliver turnkeymanufacturing lines for our clients.

Key Responsibilities

In accordance with production and plant engineering core duties, responsibilities include:

Production Plant & Line Design: Formulate plant layout, process flow diagrams(PFDs), and piping and instrumentation diagrams (P&IDs) for pharmaceutical andbiotech manufacturing facilities in accordance with cGMP, sanitary standards, andrelevant safety codes.

Machinery & Equipment Specification: Determine production requirements anddraft technical engineering specifications for mechanical equipment, filtration skids,pumps, valves, bioreactors, and automated packaging/filling machinery.

Fabrication & Construction Coordination: Interface directly with mechanicalfabricators, builders, and installation technicians to ensure equipment fabrication andphysical plant build adhere strictly to engineering tolerances, architectural layouts,and approved designs.

Testing, Commissioning & Quality Verification: Lead on-site machineryintegration, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), andoperational qualification (IQ/OQ). Troubleshoot electromechanical faults and optimizeproduction parameters to ensure plant output, cycle times, and quality standardsmeet client requirements.

Process Optimization & Maintenance Procedures: Establish preventativemaintenance schedules, machine calibration guidelines, and standard operatingprocedures (SOPs) to ensure long-term plant reliability, worker safety, andoperational efficiency.

Technical Documentation & Compliance Handover: Prepare comprehensivecommissioning reports, mechanical handover dossiers, and compliancedocumentation for client stakeholders.

Requirements & Qualifications

Education: Master’s degree in Biomedical Engineering, Chemical Engineering,Mechanical Engineering, or a closely related engineering field.

Experience: 1–3+ years of practical engineering experience within pharmaceutical,biotech, chemical, or advanced manufacturing production environments (entry-levelpostgraduates with strong project/internship plant experience are welcome to apply).

Technical Competence: Proficient in 2D/3D CAD software (e.g., AutoCAD, SolidWorks) and processflow modeling tools.

Solid understanding of fluid handling systems, pumps, piping, sanitary design,and electromechanical equipment.

Familiarity with pharmaceutical manufacturing compliance frameworks (GMP,ISO, TGA regulations) is highly regarded.

Problem-Solving & Hands-on Aptitude: Strong field troubleshooting skills with theability to diagnose process bottlenecks and machinery malfunctions on-site.

Communication: Clear technical documentation abilities and confident client-facingcommunication skills.