Senior Process Engineer – Pharma CQV & Validation Expert

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

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.