C&Q Engineer (Biotech)

Location: Melbourne, Australia

Company

hirify.global provides consulting and technical services for pharmaceutical, biotechnology, medical device, and other GMP-regulated environments.

What you will do

• Plan, coordinate, and execute commissioning, qualification, and validation activities for GMP systems and equipment.
• Develop and review qualification protocols, test documentation, validation reports, SOPs, technical specifications, and quality documentation.
• Support FAT, SAT, commissioning, and qualification activities throughout the project lifecycle.
• Collaborate with Engineering, Quality, Manufacturing, and Project teams to deliver projects successfully.
• Manage project activities and timelines, provide status reports to the PSC Project Manager, and consult with and mentor client and local teams.
• Ensure compliance with cGMP requirements, regulatory standards, and company quality systems.

Requirements

• Bachelor’s degree in Engineering, Science, or a related discipline.
• 5+ years of experience in pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
• Experience applying a risk-based CQV approach.
• Proficiency in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation.
• Experience developing SOPs, final reports, validation policies, and quality policies.
• Experience with temperature mapping of controlled temperature chambers and qualification of benchtop autoclaves, using systems such as Kaye Validator or Testo.

Nice to have

• Experience with digital validation platforms, preferably Kneat.

Culture & Benefits

• Consulting work supporting clients and local project teams.
• Opportunities to provide technical consultation and mentoring.
• Work involving regulated pharmaceutical, biotechnology, and medical device environments.