Validation Engineer

5 months ago


Singapore MIKRON SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

Main Responsibilities:

1. Assist Quality and Validation Manager Asia to complete the tasks in time with good quality.

2. Responsible for successful execution the Validation functions for customer project, as required – Quality, Cost, Time.

3. Responsible to drive and support project team for projects where validation is required and ensure execution is compliance to Mikron standards.

4. Provides training on qualification activities

5. Responsible for maintaining qualification documentation standards and procedures.

6. Create and maintain qualification/validation documentation from the design phase of projects for mechanical, software, and hardware parts.

7. Lead the qualification/validation activities of projects (risk analysis, protocol drafting, and test execution during FAT/SAT) internally and at our partners' sites (approximately 20% of the time on travel throughout the year).


Qualifications:

· Education: Bachelor’s degree/diploma in mechanical engineering or equivalent; or at least 5 years related experience and/or training; or equivalent combination of education and experience.

· Minimum 2 years of work experience in quality or validation of automated systems (mechanical, software, and hardware) or equivalent.

· Work experience in control systems design (design or programming coding) will be an advantage.

· Excellent understanding of shop practices in assembly, test & debug and final acceptance

· Computer skills including Intermediate to advanced working knowledge of MS Excel/Word/PowerPoint with demonstrated record of spreadsheet creation and maintenance.

· Proficient in English (Able to speak, read and write)


Tell employers what skills you have

Microsoft Office
Risk Assessment
Hardware
Control Systems Design
GMP
Investigation
Protocol
Compliance
Python
Regulatory Requirements
Assembly
Life Sciences
Test Execution
Manufacturing
Commissioning
Mechanical Engineering

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