C&Q Engineer - Pharmaceutical Packaging
- Melbourne, VIC
- Permanent
- Full-time
- Experience and in-depth understanding of packaging system life-cycle deliverables from commissioning and qualification (C&Q), regulatory requirements, design specifications and operational standards.
- Documentation: Authoring and reviewing documents like User Requirements Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Compliance: Ensuring that packaging systems meet Good Manufacturing Practices (GMP), GAMP 5, and other relevant regulatory guidelines.
- Testing: Leading and executing commissioning and qualification activities to validate the functionality and performance of packaging equipment.
- Collaboration: Working with various teams, including engineering, quality assurance, and manufacturing, to ensure projects are executed correctly.
- Risk Management: Conducting risk assessments and managing deviations and change controls.
- Strong understanding of regulatory guidelines, such as GMP and GAMP 5.
- Experience with packaging equipment and clean utility systems.
- Excellent technical writing and communication skills.
- Ability to work independently and manage multiple priorities in a dynamic environment.