GMP C&Q Engineer: Commissioning & Validation Leader

CSL; Melbourne; On-site; AUD 100,000 - 140,000; Full time

Job summary

CSL in Melbourne is seeking a Commissioning & Qualification Engineer to support commissioning, qualification and maintenance of manufacturing systems in a GMP environment. You will work with Process Engineering, Validation, Quality Control and Manufacturing Operations to ensure equipment, facilities and processes meet CSL quality standards.

You will prepare and review qualification protocols, manage document control, train new staff, and contribute to continuous improvement while adhering to

Qualifications

• Tertiary qualification required in Science or Engineering.
• Experience in pharmaceutical manufacturing is highly desirable.
• Strong understanding of cGMP and commissioning/qualification principles.
• Proficient in Microsoft Office applications.

Responsibilities

• Execute commissioning and qualification activities for facilities, equipment, utilities, and systems within a GMP-regulated environment.
• Prepare, review, and maintain qualification/commissioning protocols, reports, and supporting documentation to ensure regulatory compliance.
• Manage document control activities, including DMS maintenance and departmental documentation for operational and regulatory requirements.
• Maintain qualification and commissioning test equipment.
• Collaborate with cross-functional teams to ensure efficient project delivery.
• Ensure activities comply with CSL quality standards, cGMP requirements, regulatory guidelines, and HSE policies.
• Participate in problem-solving, investigations, and continuous improvement initiatives.
• Support HS&E risk assessments, maintain training compliance, and provide training to new team members.

Skills

cGMP knowledge

Stakeholder engagement

Problem solving

Organisational skills

Communication skills

Education

Tertiary qualification in Science or Engineering

Tools

Microsoft Office

Job description

CSL in Melbourne is seeking a Commissioning & Qualification Engineer to support commissioning, qualification and maintenance of manufacturing systems in a GMP environment. You will work with Process Engineering, Validation, Quality Control and Manufacturing Operations to ensure equipment, facilities and processes meet CSL quality standards.

You will prepare and review qualification protocols, manage document control, train new staff, and contribute to continuous improvement while adhering to