GMP C&Q Engineer: Pharma Validation & Commissioning

Csl Behring; Melbourne; In loco; AUD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

CSL Behring in Broadmeadows, VIC is seeking a Commissioning & Qualification Engineer to support and execute qualification, commissioning, and maintenance of manufacturing systems within a GMP environment.

You will collaborate with Engineering, Validation, Quality, and Operations to deliver compliant projects, prepare protocols and documents, and maintain equipment and test rigs. This permanent full-time role emphasizes cGMP knowledge, problem solving, and mentoring junior staff.

Competenze

• Tertiary qualification in Science or Engineering, or equivalent commissioning/qualification experience.
• Experience in pharmaceutical manufacturing is highly desirable, with strong computer literacy and proficiency in Microsoft Office.
• Sound understanding of cGMP requirements and commissioning/qualification principles.

Mansioni

• Execute commissioning and qualification activities for facilities, equipment, utilities, and systems within a GMP environment.
• Prepare, review, and maintain qualification/commissioning protocols, reports, and supporting documentation for regulatory compliance.
• Manage document control activities, including DMS maintenance and departmental documentation.
• Collaborate with cross-functional teams to ensure efficient project delivery.
• Support HS&E risk assessments and provide training to team members.

Conoscenze

Cross-functional collaboration

Microsoft Office

Strong communication

Problem solving

cGMP knowledge

Training and mentoring

Formazione

Science or Engineering degree

Strumenti

DMS (document management)

Descrizione del lavoro

CSL Behring in Broadmeadows, VIC is seeking a Commissioning & Qualification Engineer to support and execute qualification, commissioning, and maintenance of manufacturing systems within a GMP environment.

You will collaborate with Engineering, Validation, Quality, and Operations to deliver compliant projects, prepare protocols and documents, and maintain equipment and test rigs. This permanent full-time role emphasizes cGMP knowledge, problem solving, and mentoring junior staff.