Associate Process Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. Allowed:
Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work surrounded by collaborative colleagues. You’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Position

Summary

The Associate Process Engineer supports daily operations in a cGMP environment by offering technical support on projects. The environment is dynamic, with multiple molecules in production simultaneously. This will accelerate an aspiring Process or Chemical Engineer’s career with early exposure to Upstream and Downstream Biologic Drug Substance Manufacturing in a CDMO. The position offers exposure to many unit operations, including Mammalian Cell Culture expansion and production in Single Use Bioreactors, as well as Monoclonal Antibody (mAb) purification through Chromatography and Filtration processes.

We will support the Process Engineers and Process Validation Engineers with Tech Transfer (TT) and Process Performance Qualification (PPQ) activities to prepare for Right-First-Time (RFT) readiness of upcoming clinical and commercial batches for our customers.

Location/Division Specific Information

This role is a full‑time permanent position, based onsite at our Kent Street, Brisbane office.

Key Responsibilities Execution and Operations Support

• Support ongoing batch execution by completing assigned standard work and reporting, under mentorship from Support and Process Engineers.
• Monitor Critical-to-Quality (CTQ) process steps during manufacturing.
• Collaborate with Operations teams on problem solving and deviation handling.
• Build and maintain execution guidance for technical and operations staff with support from Project Engineers.
• Support delivery of Key Performance Indicators for the Brisbane site and Large Molecule network.

Documentation and Protocol Drafting

• Author GMP‑Critical documentation including Standard Operating Procedures (SOPs), Validation Protocols/Reports, Master Batch Records, Process Flow Diagrams, Risk Assessments and Bills of Materials (BOM).
• Maintain GMP documentation and written guidance, ensuring accuracy and version control.

Data Handling and Process Supervision

• Manage the Process Data Management System (Discoverant) by ensuring accurate data recording, detailed analysis, and scheduled reporting.
• Compile data and statistical analysis for Continued Process Verification (CPV), process monitoring and problem solving.

Technology Transfer and Project Assistance

• Assist with technology transfer and implementation of New Product Introductions (NPIs) for our customers.
• Support facility fit process modelling as directed.
• Support CAPEX projects through introduction of new technologies to the facility.

Continuous Improvement and Compliance

• Participate in Practical Process Improvement (PPI) activities by identifying improvements in ways of working and supporting implementation.

Qualifications & Experience

• Tertiary degree in Chemical or Process Engineering (preferably Master-level majoring in Pharmaceutical Processing, Bioprocess, Biomedical).
• Up to 2 years of industry experience or internship in Bioprocessing, Biopharma, pharmaceuticals at lab to manufacturing scale advantageous.
• Experience in technology transfer and scaling up is advantageous.

Skills & Attributes

• Proficient with Microsoft Office suite.
• Demonstrated learning agility to new technology and systems.
• Experience with coding software advantageous (e.g. Python, MATLAB, VBA).
• Ability to apply Engineering first principles to problem solving.
• Excellent interpersonal skills and professionalism in the workplace.
• Continuous Improvement methodology (Lean, Six Sigma)…