CQV Engineer – GMP Biotech Validation & Commissioning

PSC Biotech; City of Brisbane; On-site; AUD 105,000 - 120,000; Full time

Job summary

PSC Biotech in Brisbane, Australia is seeking a Commissioning, Qualification, and Validation (CQV) Engineer. You will work with a multidisciplinary team to plan and execute CGMP-compliant validation activities across facilities, utilities, and equipment.

The role requires 3+ years CQV experience in biotech/pharma, strong documentation practices, risk assessment, and reliable communication. This on-site position offers growth in a dynamic, globally connected environment.

Qualifications

• 3+ years’ experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
• Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
• Experience with system impact assessment and risk assessment.
• Good knowledge of the code of GMP and PIC/S code.
• Must be adaptable, customer service oriented, have a positive attitude.
• Excellent organizational skills and high attention to detail.

Responsibilities

• Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
• Draft, execute, review, and approve validation documentation meeting cGMP and regulatory standards.
• Draft and execute validation documents such as Master Plans, URS/DS/FS, IQ and OQ scripts, and protocols.
• Initiate and coordinate risk analyses, design reviews, FAT/SAT, IQ, OQ, and PQ.
• Conduct risk assessments and ensure ongoing validation compliance and improvements.
• Communicate progress and collaborate with multiple departments on project activities.

Skills

CQV experience

GxP knowledge

Written and verbal communication

Attention to detail

Project management

Education

Bachelor's degree in science or engineering

Job description

PSC Biotech in Brisbane, Australia is seeking a Commissioning, Qualification, and Validation (CQV) Engineer. You will work with a multidisciplinary team to plan and execute CGMP-compliant validation activities across facilities, utilities, and equipment.

The role requires 3+ years CQV experience in biotech/pharma, strong documentation practices, risk assessment, and reliable communication. This on-site position offers growth in a dynamic, globally connected environment.