Company Description
Our client is a leading services supplier providing solutions to the Pharmaceutical, Biotechnology, Life Science, and Medical Device industries. Their expertise spans Laboratory Services, Regulatory & Compliance, Engineering, Project Management, and Validation.
Role Overview
The Cleaning Validation Specialist will coordinate and lead cleaning validation activities, including the preparation and execution of protocols and reports. The role involves oversight of cleaning validation processes, investigation of deviations, and providing technical support across manufacturing operations.
Key Responsibilities
- Coordinate and lead cleaning validation activities across manufacturing operations
- Prepare, execute, and report on cleaning development and validation protocols
- Design and develop cleaning procedures for new products and manufacturing equipment
- Provide technical support for cleaning activities within the manufacturing process
- Lead the cleaning validation program and associated activities
- Support implementation of cleaning strategies, including training, for product transfer and development projects
- Investigate deviations, discrepancies, and out‑of‑specification cleaning results, including root cause analysis and troubleshooting
- Review and approve Manufacturing Cleaning Working Instructions and related documentation
- Support periodic reviews of cleaning validation studies
- Ensure timely and effective resolution of cleaning validation incidents and deviations
- Raise and manage Change Controls related to cleaning procedure updates
- Train Manufacturing, QC, and QA personnel on cleaning validation documentation and practices
- Bachelor’s or Master’s degree in Science, Pharmacy, or Engineering
- Minimum 5 years’ experience in cleaning validation (medical device preferred; pharmaceutical or biotechnology experience also considered)
- Strong knowledge of cleaning validation, continuous improvement, and troubleshooting methodologies
- Solid project management, planning, and organisational skills
- Proven leadership, teamwork, and stakeholder‑engagement capabilities
- Strong risk assessment and risk management skills
- Excellent analytical, assessment, and problem‑solving abilities
- Effective technical writing, presentation, and verbal communication skills (English)
- Sound understanding of cGMP and applicable medical device or pharmaceutical regulations
- Immediate start required
- Candidates with relevant experience and valid work rights are encouraged to apply
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on 0437 853 201.