C&Q Engineer

CSL; Melbourne; Presencial; AUD 100 000 - 140 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

cGMP knowledge

Stakeholder engagement

Problem solving

Organisational skills

Communication skills

Formação académica

Tertiary qualification in Science or Engineering

Ferramentas

Microsoft Office

Descrição da oferta de emprego

The Opportunity:

The Commissioning & Qualification (C&Q) Engineer is responsible for supporting and executing the commissioning, qualification, and maintenance of manufacturing systems and equipment within a regulated GMP environment. The role ensures that equipment, facilities, and processes are commissioned and qualified in accordance with CSL quality standards, regulatory requirements, and health, safety, and environmental guidelines.

The position plays a key role in the preparation, execution, and maintenance of qualification and commissioning activities, while working closely with cross-functional teams including Process Engineering, Project Delivery, Validation, Stability, Quality Control, Value Streams, R&D, and Manufacturing Operations to deliver projects safely, efficiently, and compliantly.

The Role:

• 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 including Engineering, Project Delivery, Validation, Quality, R&D, QC, and Manufacturing to ensure efficient project delivery.
• Ensure all activities are performed in accordance with CSL quality standards, cGMP requirements, regulatory guidelines, and HSE policies.
• Participate in problem-solving, investigations, and continuous improvement initiatives to optimise processes and systems.
• Support HS&E risk assessments, maintain training compliance, and provide training and mentoring to new team members.

To be successful:

• Tertiary qualification in Science or Engineering, or equivalent commissioning/qualification experience.
• Experience within a pharmaceutical manufacturing environment is highly desirable, with strong computer literacy and proficiency in Microsoft Office applications.
• Sound understanding of cGMP requirements, commissioning and qualification principles, and relevant industry standards and guidelines.
• Strong written, verbal, presentation, and interpersonal communication skills, with the ability to engage effectively with stakeholders.
• Demonstrated problem-solving, negotiation, and customer-focused mindset, with the ability to drive outcomes and continuous improvement.
• Highly organised and adaptable, with the ability to manage multiple priorities and deliver tasks within established timelines and project schedules.