Itot Engineer

**Key Responsibilities**:

- Design, develop, configure and commission PLC, SCADA or other automation system.
- Perform installation, configuration and troubleshooting of Windows OS migration for GMP computerised system.
- Draft and execute commissioning and qualification documentations such as for FAT, UAT, test script and IOQ.
- \Support system architecture design, data integrity assessment, electronic records and electronic signature assessment, specification development, control strategies and library development.
- Contribute to change management, deviation / non-conformance and system documentations.
- Support Computer System Validation (CSV) activities.
- Support system integration and related deliverables.

**Requirements**:

- Hold Bachelor’s degree in Life Sciences, Engineering or related field.
- Have worked for at least 2 years in pharmaceutical, medical device or related environment.
- Have experience in configuring and commissioning of PLC, SCADA and/or other automation systems.
- Have experience in Windows OS especially in OS migration.
- Have worked with automation hardware and OT shop floor technologies.
- Understand pharmaceutical manufacturing and IT/OT operations.
- Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11) and industry best practice documents / standards (e.g., GAMP5, ISA 88, ISA 95).
- Understand SDLC and quality management requirements of the pharmaceutical industry.
- Preferably with relevant training and certifications.

**Why Join Orka**:

- **Work that Matters**: Support clients bringing innovative and life saving solutions to the population.
- **Career Development**: Build a consulting career in a professional consulting company with Life Sciences focus.
- **Professional Environment**: Work with similar professionals possessing **Intelligent, Resourceful, Loyal and Teamwork** characteristics.
- **Impactful Learning and Mentoring**: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

Pay: From $4,200.00 per month

Work Location: In person