Lead Process Engineer - Energy & Resources

Stantec Australia; Melbourne; On-site; AUD 140,000 - 180,000; Full time

Job summary

Stantec Australia is seeking a Senior Process Engineer to advance GMP-regulated pharmaceutical process development at Melbourne-based facilities. You will lead design reviews, technology transfer, and risk assessments, ensuring equipment and systems meet validation and compliance standards.

You will mentor teams across project, operations and quality, drive CQV activities, and support qualification, change control, and continuous improvement initiatives in sterile and fill-finish environments.

Qualifications

• Proficient in drafting and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

Responsibilities

• Provide technical leadership for process technology across projects and manufacturing support activities.
• Develop and maintain clear process design requirements aligned with regulatory expectations.
• Review process data and transfer packages to support equipment and system design decisions.
• Partner with project, operations, quality and engineering teams to integrate solutions into manufacturing environments.
• Lead risk-based assessments and identify process improvements to mitigate risks.
• Support design, commissioning, qualification and validation of process systems for performance and compliance.
• Provide SME input during design reviews, troubleshooting, investigations and process optimization.
• Ensure changes are documented and implemented through quality and change management systems.
• Facilitate risk assessments, FMEAs, and process hazard analyses for project delivery.

Skills

DQ/FAT/OQ/IQ

CQV protocols

cGMP compliance

Kneat

PFS & sterile processes

Tools

Kneat

Job description

Senior Process Engineer – Pharmaceutical

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.

Location: Melbourne.

• 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.

Closing date: Sunday 25th October 2026 @ 11:55am.