Process & Commissioning Engineer (Biotech)

TL;DR

Process & Commissioning Engineer (Biotech): Supporting a 12-month manufacturing project with an accent on commissioning, qualification, and process optimization within a GMP-regulated environment. Focus on integrating new equipment, executing IQ/OQ/PQ protocols, and ensuring operational readiness in a live manufacturing facility.

Location: Must be based on-site in Melbourne, Australia

Company

hirify.global is a professional services firm providing specialized consulting and engineering solutions to the life sciences industry.

What you will do

• Lead and execute commissioning activities for new and upgraded manufacturing equipment.
• Support process development and optimization to improve performance and reliability.
• Coordinate with project, operations, and quality teams for seamless system integration.
• Develop and execute commissioning plans, protocols, and documentation in line with GMP requirements.
• Support equipment qualification (IQ/OQ/PQ) and ensure readiness for validation.
• Contribute to risk assessments, HAZOPs, and change control processes.

Requirements

• Bachelor’s degree in Engineering (Chemical, Process, Mechanical, Biomedical, or related).
• 3+ years of experience in GMP-regulated industries (pharmaceutical, biotech, or medical devices).
• 2+ years of proven experience in commissioning and qualification of manufacturing equipment.
• Strong understanding of GMP requirements, quality systems, and validation principles.
• Demonstrated experience working within operational manufacturing environments.
• Must be available for on-site work in Melbourne and flexible to support shift work including evenings, nights, or weekends.