GMP C&Q Engineer - Commissioning & Qualification Pro

CSL; Broadmeadows; On-site; AUD 120,000 - 170,000; Full time

Job summary

CSL Behring is seeking a Commissioning & Qualification Engineer to support and execute the commissioning, qualification, and maintenance of manufacturing systems in a GMP environment. You will work with Process Engineering, Validation, Quality Control, and Manufacturing Operations to deliver compliant projects.

The role focuses on preparing and maintaining qualification documentation, managing DMS and test equipment, and ensuring adherence to cGMP and HSE policies while mentoring new team

Qualifications

• Degree in Science or Engineering or equivalent commissioning/qualification experience.
• Experience in a pharmaceutical manufacturing environment is highly desirable.
• Strong computer literacy and proficiency in Microsoft Office.
• Sound understanding of cGMP requirements and qualification principles.

Responsibilities

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

Skills

Pharma manufacturing experience

MS Office proficiency

cGMP understanding

Strong communication

Problem-solving

Organised and adaptable

Education

Science or Engineering degree

Tools

Microsoft Office

Job description

CSL Behring is seeking a Commissioning & Qualification Engineer to support and execute the commissioning, qualification, and maintenance of manufacturing systems in a GMP environment. You will work with Process Engineering, Validation, Quality Control, and Manufacturing Operations to deliver compliant projects.

The role focuses on preparing and maintaining qualification documentation, managing DMS and test equipment, and ensuring adherence to cGMP and HSE policies while mentoring new team