Validation Engineer

3 days ago

Bengaluru, Karnataka, India Pharmaval Full time ₹ 4,20,000 per year

Job Summary

The Validation Engineer must background in developing life-cycle documents for equipment, process and utility equipment's supporting API & Formulation operation in pharma domain . The person is responsible for the development of documents as part of validation deliverables for a project. In execution of these responsibilities, the Quality Validation Specialist should have strong testing, writing and validation skills relevant to equipment, process and utilities w.r.t to bio/pharma industry.

Responsibilities and Duties

  • Generate validation plans, protocols and reports that support the qualification and validation of systems.
  • Generate User Requirement Specifications (URS), Functional Specifications for process equipment/ utilities
  • Generate Risk Assessment Documents
  • Compile data for completed validation and prepare final report packages by summarizing the data.
  • Investigate deviations, write investigation reports and create summary reports.

Qualifications and Skills

  • Bachelor's Degree; scientific background preferred
  • At least 2-4 years of pharmaceutical validation experience
  • Good knowledge of GMPs and experience in generating validation documents (IQ,OQ,PQ) as per relevant industry regulations and guidance
  • Strong interpersonal skills and demonstrated ability work independently
  • Organized and task oriented
  • Excellent written and oral communication skills especially on technical topics
  • Proficient with MS Office tools

Job Type: Full-time

Pay: ₹25, ₹35,000.00 per month

Ability to commute/relocate:

  • Bengaluru, Karnataka: Reliably commute or planning to relocate before starting work (Preferred)

Education:

  • Bachelor's (Preferred)

Experience:

  • CGMP: 2 years (Required)
  • Document management: 2 years (Preferred)

Language:

  • Kannada & Hindi (Preferred)

Work Location: In person

Expected Start Date: 03/11/2025

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