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Validation Engineer

Navitas Life Sciences
Navitas Life Sciences
0-2 years
Not Disclosed
10 May 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

 

Validation Engineer


Job Summary

We are looking for a dedicated Validation Engineer to support validation efforts by authoring and executing qualification test scripts. The successful candidate will work closely with cross-functional teams to ensure systems meet user and regulatory requirements, and that any defects are tracked and resolved efficiently.


Key Responsibilities

  • Understand user and functional requirements documents thoroughly

  • Author OQ (Operational Qualification) and PQ (Performance Qualification) test scripts based on Functional Requirement Specifications (FRS)

  • Perform dry runs of test scripts and report any identified defects

  • Incorporate review comments and test script corrections, and submit scripts for pre-approval

  • Execute formally approved OQ test scripts and document any defects

  • Follow established defect management processes to log and track defects

  • Perform test case re-execution as required to confirm defect resolution and compliance


Desirable Skills and Experience

  • Experience in validation activities within regulated industries (e.g., pharmaceuticals, biotech, or medical devices)

  • Knowledge of OQ/PQ test script writing and execution

  • Familiarity with GxP practices, FDA 21 CFR Part 11, and other applicable regulatory standards

  • Understanding of defect lifecycle and defect management tools

  • Strong attention to detail and documentation skills

  • Ability to work independently as well as in a team environment

  • Good verbal and written communication skills