Senior Cleaning Validation Engineer
ND Reference: JDSG1705062.01CVS
Position available with No Deviation Pte. Ltd. supporting a MNC Client in the pharmaceutical industry.
The candidate will be responsible for preparing and executing test documentation for Cleaning Validation of systems as well as support in the troubleshooting of issues during test execution. The candidate should have excellent understanding of ICH standards, EMA and FDA (GxP) regulations, and methodologies.
- Create and modify validation documentation including but not limited to:
- Criticality assessments
- Cleaning Validation protocols which verify if the system is compliant to regulatory and client requirements.
- Reports which summarize the results of the protocol executions.
- Exception reports which identify defects or issues during test execution.
- Contribute to status reporting
- Identify issues and communicate to client counterpart
- Review executed protocols and generated reports in accordance with GMP and document quality requirements
- Assist in troubleshooting of issues identified by test performers during protocol execution.
Considerations / Requirements:
- A degree in Engineering or Science disciplines
- At least 7 years’ relevant experience working with Cleaning Validation in a regulated industry
- Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
- Proactive, self-starter and capable of working alone or in a team environment
- Excellent written and verbal communication skills
- Experienced in developing protocols
- Good knowledge of cGMP, GDP and ICH Q10 guidelines
- Knowledge of ASTM 2500E risk-based approaches
- To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle
- Be IT-literate and familiar with Microsoft office suite of applications
- Proven track record in following and promoting Safety in all aspects of your role
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