AM

Validation Lead

Amgen Inc
Hyderabad4-6 LPA Posted 8 May 2025
FULL TIME
Software Testin
Analytical Skills
Gmp

Job Description

Must-Have Skills:

  • 2+ year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.).
  • 5+ to 9 Years overall experience in Testing with 2+ years of experience in validation experience is mandatory.
  • Experience leading software validation projects.
  • Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation.
  • Familiarity with computer system validation and software validation is a plus
  • Strong problem-solving and analytical skills
  • Excellent communication and teamwork skills.

Good-to-Have Skills:

  • Experience with automated and computer-controlled systems validation (21 CFR Part 11)
  • Education and Professional Certifications
  • Bachelor's /Masters degree in computer science and engineering preferred, other Engineering field is considered
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