- C&Q of Packaging Equipment / Systems
- Pharmaceutical Project – Sterile Manufacturing
- 12 Month Contract
Our client is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, servicing the pharmaceutical, medical device, biotechnology and animal health industries
We are seeking a Project Engineer to work on a 12 month project, with extensive experience in commissioning and qualification of packaging equipment and systems for a pharmaceutical company located in the Northern suburbs of Melbourne.
Key Responsibilities & Criteria:
- 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.
Essential Skills:
- 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.
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on 0437 853 201.