CQV Engineer II (Biotech)

Location: Melbourne, Australia

Company

hirify.global delivers commissioning, qualification, and validation services for life science and pharmaceutical projects.

What you will do

• Support commissioning, qualification, and validation of facilities, utilities, and equipment.
• Author, revise, review, and complete controlled CQV documents, including GMP and GDP documentation and technical specifications.
• Coordinate risk analyses, design reviews, FAT/SAT, IQ, OQ, and PQ activities.
• Develop SOPs, review final reports, and maintain CQV procedures and policies.
• Collaborate with client teams, departments, contractors, and vendors on project deliverables.
• Manage project activities and timelines, provide status updates, and mentor clients and junior engineers.

Requirements

• Bachelor’s degree in Engineering or Life Science.
• 5–7 years of applicable experience in the biomedical and pharmaceutical industry, including at least 3 years in CQV.
• Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Experience developing SOPs, final reports, and validation and quality policies.
• Good understanding of and compliance with cGMP and data integrity guidelines.
• Strong communication, presentation, analytical, organization, time-management, and multitasking skills.

Culture & Benefits

• Work closely with client teams and multiple departments.
• Provide technical guidance, consultation, and knowledge sharing.
• Travel as needed for assigned projects.
• Work across changing priorities and multiple project timelines.