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Manufacturing Automation Consultant

2 weeks ago

Singapore TRITON AI PTE. LTD. Full time

**Perm with Attractive Benefits and Career Development Growth**:

- **Exposed to Computer System Validation (CSV, ISPE GAMP5 Risk-based approach) and its key components towards inspection readiness in life science or health category domains**:

- **Min 4 - 6yrs working experience with Min 2 - 4yrs in Manufacturing-IT, Engineering Automation, preferably in the field of pharmaceuticals**:

- **Experience with at least mínimally 1 end-to-end automation implementation project cycle eg. DCS, MES, OIS PI Historian, if any**
- End-to-end automation implementation project cycle eg. DCS, MES, OIS PI Historian, if any
- MES (manufacturing execution system): WERUM PAS|X, Emerson Syncade, POMSnet, Lonza MODA etc.
- DCS (distribution control system): Emerson DeltaV, Yokogawa Centum, Siemens PLC, OSI PI, Historian etc.
- Exposure to software development/troubleshooting, C++/C#, Java script, Visual Basic, databases SQL, SQL+
- Exposure to batch manufacturing such as recipe/SFC workflow design, and/or software patch/hotfix, system design/development lifecycle management preferred eg. change, incident, deviation, release etc.
- Experience in Good Documentation Practice (GDP), policy guideline, procedural governance and process
- Experience with test protocols and executions eg. IQ/OQ/PQ, test scripts with relevant key deliverables such as plan, report, deviation, change control and industry best practices etc.
- Review, evaluate system functions, its business processes, and workflows etc.

**Requirements**:

- Exposed to Computer System Validation (CSV, ISPE GAMP5 Risk-based approach) and its key components towards inspection readiness in life science or health category domains
- Exposed to CSV key documentations eg. VP/ URS/ FS/ CS/ DS/ FRA/ FAT/ SAT/ UAT/ RTM etc.
- Experience with QMS (quality management systems) eg. risk impact or functional assessment(s)
- Ability to communicate quality, validation, risk-related concept to technical and non-technical audiences
- Knowledge of standards/guidelines eg. ISO9001:2015, ANSI/ISA-88/-95, 21CFR Part 11/210/211 and/or Health Regulatory authorities’ regulations; EU Annex 11, MHRA, USFDA, ANVISA, NMPA, ICH Q7/Q9
- Good written and presentation skills
- Demonstrate ability to work independently, as team member and/or leading team against deliverables
- Good organizational skills, diligent in task assignments/deliverables, timelines, and quality deliverances
- Pro-active mindset, attention to details, go-getter attitude, grit, and willpower to face any challenge

**Triton AI Pte Ltd**
**Registration Number: R1980724**
**EA: 21C0661