Automation Validation Engineer
ND Reference: JDSG201709.081.01AVE
Candidate with pharmaceutical background and experience in Validation required to apply expertise in the systematic and detailed review of CSV documentation.
Must have strong knowledge and understanding of validation life-cycle and apply both site quality requirements and standard GMP requirement.
- Generate, review and/or approve qualification/validation documentations for the DeltaV (Automated Process Control and Computerized) system.
- Establish systems are in place that ensure data integrity, and compliance to Client Computer System Validation Master Plan and 21CFR Part 11 requirements.
- To analyze, identify and resolve issues that potentially impact the validated status of API DeltaV.
Considerations / Requirements:
- Degree in Engineering, Science or related technological field
- At least 5 – 7 years’ experience in CSV within the pharmaceutical industry
- Familiar in the validation life cycle of Automated Process Control and Computerized System is necessary
- Good Hand-on experienced in Emerson DeltaV, especially in pharmaceutical and biologic manufacturing environment
- 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
- Comprehensive understanding of commissioning, qualification and verification requirements
- Good knowledge of cGMP, GDP and ICH Q10 and ASTM E2500 risk-based approaches will be an advantage.
- Support updating document trackers to monitor status of all documents
- 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
- Good communication skills (technical writing and verbal communication/presentation)
- Interacts effectively with variety of communication and working styles
- Able to provide internal validation training if required
- 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