CQV Engineer – GMP Validation (Rolling Contract)

About the role

The CQV Engineer will support the commissioning, qualification and validation of Southern RNA’s GMP manufacturing facility in Eight Mile Plains, Brisbane. Working on‑site, you will collaborate with Engineering, Validation, Quality Assurance and Operations to ensure all systems meet regulatory standards for clinical RNA production.

Key responsibilities

• Lead and facilitate FMEA and other GMP risk assessments.
• Develop, review and execute commissioning and qualification documentation for GMP systems and equipment.
• Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols, and produce qualification reports.
• Prepare validation lifecycle documents such as Validation Plans, User Requirements Specifications (URS), Design Qualification (DQ), Traceability Matrices and Validation Summary Reports.
• Review vendor FAT, SAT and commissioning documentation.
• Support deviation investigations, change controls and CAPAs arising from qualification activities.
• Collaborate with multidisciplinary teams and external contractors to deliver projects on schedule.
• Ensure compliance with PIC/S GMP, GAMP 5 and Annex 11 principles and assist with regulatory inspections.

Required profile

• Degree in Engineering, Science, Biotechnology or related discipline.
• Minimum 3 years experience in CQV, Validation or Qualification Engineering within a GMP pharmaceutical, biotechnology or medical device environment.
• Proven experience performing FMEA and GMP risk assessments.
• Hands‑on experience authoring and executing IQ/OQ protocols.
• Strong understanding of GMP validation lifecycle principles and excellent technical writing skills.

Required skills

• FMEA
• GMP risk assessment
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Commissioning protocols
• Validation Plans
• User Requirements Specifications (URS)
• Design Qualification (DQ)
• Traceability Matrices
• Validation Summary Reports
• GAMP 5
• Annex 11