Validation Engineer

1 week ago

Bayan Lepas, Penang, Malaysia IMA AUTOMATION MALAYSIA SDN BHD Full time

We are looking for a Validation Engineer to join our team. In this role, you will be responsible for ensuring the validation and verification of automated equipment, working cross-functionally to ensure compliance and continuous improvement. If you have experience in managing validation processes for automated machinery, understand regulatory requirements, and have a proactive approach to problem-solving, we encourage you to apply.

Job Responsibilities:

  • Develop and implement validation plans, procedures, and protocols to ensure the proper validation and verification of automated equipment.
  • Perform machine verification and validation (IQ and OQ) to ensure equipment compliance with operational and regulatory requirements.
  • Coordinate design specifications (FDS, HDS, SDS, VDS) with the Engineering department to ensure alignment with validation requirements.
  • Lead risk assessments, FMEA, and change control processes to maintain the validated state of equipment.
  • Collaborate with relevant personnel to investigate discrepancies during validation executions and implement corrective actions and improvements.
  • Support Project Managers with customer interactions and validation-related issues as necessary.

Job Qualifications:

  • Proven experience in managing the validation of automated machinery.
  • Holding a minimum Diploma in Engineering or related field.
  • Strong knowledge of medical device quality system regulations, such as 21 CFR 820, ISO 13485, and ISO 14971.
  • Experience working within FDA and European regulatory environments (e.g., CE Marking).
  • Proficiency in reading electrical schematic diagrams.
  • Proficiency in reading mechanical assembly drawings.
  • Experience in machine assembly and fine-tuning is a plus.

If you are detail-oriented, have a solid understanding of validation processes, and thrive in a collaborative environment, we'd love to hear from you

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