Validation Engineer

3 weeks ago

Bengaluru, Karnataka, India Tek Support Full time

Job Title: CQV (Commissioning, Qualification & Validation) Engineer

Location: Complete Remote

Experience: 7-15 Years

Industry: Pharmaceuticals / Biotechnology

Job Overview:

We are seeking a CQV Engineer with proven experience in commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities, equipment, and utilities. The ideal candidate will have strong knowledge of cGMP, GAMP 5, ICH guidelines, and global regulatory expectations, with a track record of delivering compliant IQ, OQ, and PQ documentation for FDA/EMA-regulated environments.

This role requires hands-on expertise in qualifying pharmaceutical process equipment (e.g., granulators, blenders, tablet presses, coating machines), cleanroom environments, and critical utilities such as purified water systems, WFI, clean steam, and HVAC systems. The successful candidate will collaborate with cross-functional teams to ensure timely and compliant project execution, supporting manufacturing readiness and audit preparedness.

Key Responsibilities:

  • Develop, execute, and review IQ, OQ, and PQ protocols for pharmaceutical process equipment, cleanrooms, and utilities in compliance with cGMP.
  • Prepare and maintain validation deliverables including risk assessments, FAT/SAT protocols, traceability matrices, and summary reports.
  • Conduct equipment and system verification against URS, P&IDs, and design specifications.
  • Perform cleanroom classification and environmental monitoring qualification.
  • Execute qualification of critical utilities including HVAC, purified water, WFI, and clean steam systems.
  • Ensure adherence to cGMP, GAMP 5, ISPE Baseline Guides, ICH Q9/Q10, and regulatory guidelines.
  • Coordinate with Quality Assurance to resolve deviations, manage change controls, and implement CAPAs.
  • Maintain audit-ready documentation for regulatory inspections.

Qualifications & Skills:

  • Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.
  • 7-15 years of CQV experience in a pharmaceutical manufacturing environment.
  • Strong understanding of cGMP, GAMP 5, ICH guidelines, and regulatory inspection requirements.
  • Proficiency in qualifying solid dosage, liquid, or sterile manufacturing equipment.
  • Experience in HVAC, purified water, WFI, and clean steam system validation.
  • Skilled in interpreting P&IDs, equipment manuals, and validation schematics.
  • Strong documentation, troubleshooting, and problem-solving skills.

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