CQV/Fill Finish Engineer (Biotech)

Location: Melbourne, Australia

Company

hirify.global provides consulting support for life science and GMP-regulated manufacturing projects.

What you will do

• Commission, qualify, and validate facilities, utilities, equipment, and filling-line systems.
• Author, revise, review, and complete controlled CQV, GMP, GDP, and technical documentation.
• Coordinate risk analyses, design reviews, FAT/SAT, IQ, OQ, and PQ activities.
• Support MES recipe startup, debugging, and documentation updates for process optimization.
• Collaborate with client teams, vendors, contractors, and cross-functional stakeholders to deliver project milestones.
• Manage project activities, timelines, status reporting, cGMP compliance, and data integrity requirements.

Requirements

• Bachelor's degree in Engineering or Life Sciences.
• Minimum 3 years of CQV and fill finish experience in GMP-regulated environments.
• Hands-on experience with vial filling equipment and processes.
• Strong understanding of cGMP requirements, data integrity, and validation lifecycle principles.
• Experience with isolators, depyrogenation tunnels, sterile filtration systems, and related aseptic processing equipment.
• Strong technical writing, communication, project management, stakeholder engagement, and prioritization skills.

Culture & Benefits

• 12-month consulting contract.
• Collaboration with client, site, vendor, contractor, and cross-functional project teams.
• Work includes hands-on support in cleanroom environments.
• Exposure to life science manufacturing and validation projects.