Senior C&Q Principal: GMP Compliance & Validation

CSL; Broadmeadows; Vor Ort; AUD 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL Behring in Broadmeadows, VIC is seeking a C&Q Senior Principal to lead qualification and commissioning across new and modified facilities, equipment, and systems. You will develop strategies, ensure global policy alignment, and provide site-wide technical leadership.

You will partner with project managers and engineers, manage delivery, and mentor teams while upholding GMP and regulatory expectations. This permanent full-time role offers a pathway to influence at scale within CSL Behring.

Qualifikationen

• Tertiary qualification in Science or Engineering.
• Minimum 5 years’ experience in pharmaceutical manufacturing with expertise in C&Q, Process Validation or Cleaning Validation.
• Strong knowledge of cGMP requirements and validation principles.
• Direct experience supporting regulatory audits and inspections (TGA, FDA) and related regulatory requirements.

Aufgaben

• Lead and manage all Qualification & Commissioning (C&Q) activities across new and modified facilities, equipment, and systems, from master plan development through execution, handover, and ongoing validation support.
• Develop, maintain, and continuously improve C&Q and Validation Master Plans, methodologies, SOPs, protocols, reports, and other departmental documentation in line with global standards.
• Partner with Project Managers, Process Engineers, Equipment Owners, and cross-functional stakeholders to embed C&Q requirements into system design and lifecycle management.
• Oversee project delivery for new and modified systems, including design reviews, resource planning, testing, implementation, and milestone achievement.
• Provide supervisory responsibilities and technical support for projects with external contractors, CAPEX/OPEX, and Change Control activities.
• Lead and mentor direct reports and project teams to ensure competency, regulatory compliance, and cross-site collaboration.
• Maintain expertise in regulatory requirements and promote GMP compliance, inspections readiness, and documentation quality.

Kenntnisse

C&Q

Process Validation

Cleaning Validation

Regulatory Audits

Ausbildung

Science or Engineering degree

Jobbeschreibung

CSL Behring in Broadmeadows, VIC is seeking a C&Q Senior Principal to lead qualification and commissioning across new and modified facilities, equipment, and systems. You will develop strategies, ensure global policy alignment, and provide site-wide technical leadership.

You will partner with project managers and engineers, manage delivery, and mentor teams while upholding GMP and regulatory expectations. This permanent full-time role offers a pathway to influence at scale within CSL Behring.