CQV Engineer II: Validation & Commissioning Expert

biotech; City of Melbourne; On-site; AUD 120,000 - 160,000; Full time

Job summary

biotech in Melbourne seeks a CQV Engineer II to support commissioning, qualification and validation of facilities, utilities, and equipment. The role requires strong CQV experience, cross‑functional collaboration, and proficient documentation practices.

The incumbent will mentor teams, manage project timelines, and work with contractors to ensure cGMP compliant deliverables, with travel as needed.

Qualifications

• Bachelor’s degree in engineering or life science required.
• 5–7 years of biomedical/pharma industry experience.
• Min 3 years of CQV experience.
• Proficient in authoring/executing DQ, FAT, SAT, IQ, OQ, PQ, PV documents.

Responsibilities

• Support commissioning, qualification, and validation of facilities, utilities, and equipment.
• Prepare, review, and revise controlled CQV documents and SOPs.
• Collaborate with multiple departments and external contractors/vendors.
• Manage project activities and timelines; provide status reports to PSC PM.

Skills

CQV execution

Project management

Analytical skills

Communication skills

Risk analysis

Documentation

Education

Bachelor’s Degree in Engineering or Life Science

Job description

biotech in Melbourne seeks a CQV Engineer II to support commissioning, qualification and validation of facilities, utilities, and equipment. The role requires strong CQV experience, cross‑functional collaboration, and proficient documentation practices.

The incumbent will mentor teams, manage project timelines, and work with contractors to ensure cGMP compliant deliverables, with travel as needed.