Validation Engineer

2 weeks ago


Singapore FLEXTRONICS MANUFACTURING (SINGAPORE) PTE. LTD. Full time
Roles & Responsibilities

Validation / Calibration

· Provides the subject-matter expertise to the site on Validation and Calibration.

· Ensures all Validation related activities adhere to required policies and procedures.

· Assists the site teams in preparation and execution of validation protocols.

· As needed, liaises with Engineering and external vendors regarding equipment or software systems User Requirement Specifications (URS’s), Factory Acceptance Tests (FAT) and any other associated validation matters.

· Pre-approves and post-approves validation protocols and assessments as required by the Quality Management System on site.

· Collates and reports on relevant Validation data/matrices.

· Monitors and ensures that the Validation program for the site continues to comply with the necessary regulations.

· Coaches/Trains the site personnel on Validation.

· Manages the calibration program i.e. utilize calibration management system to maintain the Calibration Master List and review Calibration Report/Certificate to ensure the equipment meets the calibration specification(s).

· Ensures compliance with the Company’s Quality System and applicable regulatory requirements such as ISO 13485.

· Contributes to continuous improvement activities.

· Lead a team of engineers and assistants.

· Contributes to the workplace safety and health improvement for the employees, as well as environmental protection, by adhering to the company’s Environmental, Health and Safety policies and procedures, and helping to achieve EHS objectives and targets through participation of EHS programs

·Participate and adhere to Corporate Social and Environmental Responsibility (CSER) policy, programs and procedures.


Validation / Calibration

· Diploma / Degree in Mechanical Engineering / Electronics Engineering / Electrical Engineering / Electromechanical Engineering / Manufacturing Process Technology

· Minimum 3 years experiences in similar role

· Familiar with IQ/OQ/PQ validation

· Familiar with statistical methodology

Familiar with ISO 13485 Quality System Requirements will be added advantage.


Tell employers what skills you have

Factory
Quality Management
Quality System
Workplace Safety
ISO
GMP
Environmental Health
Regulatory Requirements
Manufacturing
Electrical Engineering
Electronics
Commissioning
Mechanical Engineering
Calibration
EHS
Workplace Safety and Health
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