Validation Engineer

2 days ago

Bayan Lepas, Penang, Malaysia Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd Full time 48,000 - 72,000 per year

Job Descriptions:

  • Ensure that validation procedures (IQ, OQ, PQ) meet quality standards and comply with FDA 21 CFR Part 820 and ISO 13485 regulations.
  • Create, update, and maintain Master Validation Plans and related reports.
  • Review validation data to confirm it meets required specifications.
  • Collaborate with Quality, Engineering, and Manufacturing teams to carry out product performance tests.
  • Support projects and process changes by identifying and implementing necessary validation steps.

Job Requirements:

  • Bachelor's degree in Engineering (Mechanical, Science, Biomedical, or related field).
  • At least 1 year of validation experience in a regulated industry (medical devices preferred).
  • Good knowledge of IQ/OQ/PQ processes and the validation lifecycle.
  • Understanding of cGMP, FDA, ISO 13485, and EU MDR requirements.
  • Familiarity with statistical analysis and risk management tools (FMEA, PFMEA).
  • Strong documentation and technical writing skills.
  • Fresh Graduates are welcome to apply.

For those who have what it takes, please apply online or send in your profile to:

Consultant: Lara

Email:

Tel :

For more job opportunities, please visit

OUR SERVICE FOR JOB SEEKER IS FREE

Job Type: Full-time

Pay: RM4, RM6,000.00 per month

Benefits:

  • Free parking
  • Health insurance
  • Opportunities for promotion
  • Professional development

Application Question(s):

  • Do you have experience in validation protocols (IQ, OQ, PQ)? (Yes or No)
  • Do you have understanding of FDA 21 Part 820, ISO 13485, cGMP, and EU MDR requirements in validation work? (Yes or No)

Experience:

  • validation: 1 year (Preferred)

Work Location: In person

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