Validation Engineer

21 hours ago


Bidaluru Bengaluru, India Akshaya Associates Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Description:

We are looking for an experienced Validation Engineer with a strong background in sterile manufacturing environments. The ideal candidate should have hands-on experience in performing and documenting validation activities, ensuring compliance with cGMP and regulatory requirements.

Key Responsibilities:

  • Execute and document validation activities including:
  • Equipment Qualification (IQ/OQ/PQ)
  • Autoclave Qualification
  • HVAC Qualification
  • Smoke Studies
  • Cleaning Validation
  • Prepare and review validation protocols and reports.
  • Coordinate with cross-functional teams (Production, Quality Assurance, Engineering) to ensure validation readiness.
  • Ensure compliance with current regulatory guidelines (USFDA, EU GMP, WHO).
  • Conduct periodic re-validation and maintain validation master plan documentation.
  • Support audit readiness and respond to audit observations related to validation activities.

Required Skills & Experience:

  • Experience: 4 – 8 years in validation within a sterile/aseptic manufacturing setup.
  • Qualification: B.E/B.Tech in Mechanical, Electrical, Instrumentation, or Chemical Engineering / M.Sc. in related discipline.
  • Technical Skills: Knowledge of cGMP, equipment qualification procedures, and validation documentation practices.
  • Soft Skills: Strong analytical, documentation, and communication skills.

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