We are desiring to recruit a strategic Validation Engineer to join our cohesive team at IMA AUTOMATION MALAYSIA SDN BHD in Southwest Penang Island District, Penang.
Growing your career as a Full time Validation Engineer is an unparalleled opportunity to develop fundamental skills.
If you are strong in strategic planning, communication and have the right initiative for the job, then apply for the position of Validation Engineer at IMA AUTOMATION MALAYSIA SDN BHD today!
Job Description:
- Develops and initiates validation plans, validation procedure and protocols to validate and verify automated equipment.
- Coordinate design specifications (FDS, HDS, SDS, VDS) with Engineering department.
- Lead risk assessment, FMEA and change control with respect to validated state of equipment.
- Work with related personnel to investigate discrepancies during validation executions and remedy through corrective actions and improvement.
- Supports Project Managers with customer interfaces as necessary on validation related issues.
Qualifications:
- Experience in managing validation of automated machine.
- Understand medical devices quality system regulations, e.g. 21 CFR 820, ISO 13485 and ISO 14971.
- Experience working in both FDA and European regulatory (e.g. CE Marking) environment.
Benefits of working as a Validation Engineer in Southwest Penang Island District, Penang:
● Company offers great benefits
● Professional Development Opportunities
● Competitive salary
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