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Showing 136 Process Engineer jobs in Melbourne

We are seeking a Senior Process Engineer to support ongoing process development within a GMP‑regulated environment. This role will play a key part in defining and managing process requirements for pharmaceutical projects, supporting system design, technology transfer, risk assessments, and compliance activities to ensure successful project execution and operational readiness.

Key Responsibilities

- Provide technical leadership in the development and implementation of process technologies across capital projects, operational improvements, and manufacturing support activities.
- Develop and maintain process design requirements, ensuring they are clearly defined, measurable, and aligned with project objectives and regulatory expectations.
- Review and interpret process data, technology transfer packages, and manufacturing requirements to support equipment and system design decisions.
- Partner with project, operations, quality, and engineering teams to ensure process solutions are effectively integrated into manufacturing environments.
- Lead technical evaluations and risk‑based assessments to identify process improvement opportunities and mitigate operational risks.
- Support the design, commissioning, qualification, and validation of new and modified process systems to ensure they meet performance and compliance requirements.
- Provide subject matter expertise during design reviews, troubleshooting activities, investigations, and process optimisation initiatives.
- Ensure process changes are appropriately assessed, documented,



and implemented through established quality and change management systems.
- Facilitate risk assessments, FMEAs, and process hazard analyses to support project delivery.
- Ensure compliance with quality, validation, engineering, and regulatory standards.
- Partner with cross‑functional teams to resolve technical issues and drive continuous improvement initiatives.

Requirements

- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPs, final reports and validation & quality policies.
- Strong experience developing and executing CQV protocols.
- Strong experience creating and maintaining CQV policies and processes.
- Has good understanding and complies to cGMPs and CFR21 Part 11 guidelines.
- Exposure to digital and paper‑based validation systems, including platforms such as Kneat.
- Background in Pre‑filled syringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product, New Product Initiative (NPI) manufacturing, Plasma Manufacturing

Blue Projects is one of the most agile firms, specializing in providing unique and bespoke Engineering and Project Management solutions for clients in the industrial sector.

To further our strategic business growth, we are looking for a passionate Process Engineer in our office in NSW or Victoria.

Requirements:





- Minimum 7 years of experience in Process Engineering/Project Management in industrial sectors, preferably FMCG or similar.
- Bachelor's or Honours Degree in Chemical/Process Engineering, Industrial Chemistry, or a related field.
- Strong skills in generating PFDs, P&IDs;, and performing process calculations such as mass and energy balances.
- Proficiency in plant layout design, piping/mechanical design, and detailing.
- Experience with multidisciplinary coordination, including civil, mechanical, electrical, automation, and production teams.
- Ability to work effectively in a team.
- Advanced time management, analytical, and interpersonal skills.
- Proficient in 2D and 3D CAD systems.
- Working knowledge of Microsoft Office; knowledge of Microsoft Project is an advantage.
- Willingness to travel for business trips and project‑related relocations.

Responsibilities:

- Review project deliverables to define process requirements.
- Develop PFDs, P&IDs;, and equipment layouts for industrial projects.
- Collaborate with clients and stakeholders to confirm project design requirements.
- Design and manage manufacturing processes to optimize safety, performance, and compliance with quality standards.
- Perform process simulations and troubleshoot issues as needed.
- Create detailed piping, insulation, instrumentation, and equipment specifications.
- Produce tender or RFQ documents as required for project execution.
- Create, verify, and validate Material Take Off (MTOs).
- Liaise with equipment, instrument, and installation suppliers on specifications, design, and delivery.
- Prepare and complete projec

📌 Process Engineer (Melbourne)
🏢 Asahi
📍 Melbourne