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Equipment Validator

2 weeks ago

Ahmedabad, Gujarat, India beBeeValidation Full time ₹ 9,00,000 - ₹ 12,00,000
Qualification and Validation Specialist

This role involves the development, execution, and documentation of qualification protocols for equipment, utilities, and facilities. The ideal candidate will have deep knowledge of qualification and validation best practices and hands-on experience with media fill/aseptic simulation, smoke studies, and utilities (water, steam, HVAC).

Key Responsibilities:
  • Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities.
  • Collaborate with cross-functional teams to coordinate qualification activities.
  • Maintain qualification documentation, including risk/impact assessments and change-control records.
  • Ensure compliance with regulatory standards.
  • Support internal and external audits and inspections focused on qualification.
Required Skills and Qualifications:
  • Proficient in URS/DQ/IQ/OQ/PQ processes for various equipment.
  • Strong understanding of equipment qualification, utility validation, and cleanroom classification.
  • Familiarity with cGMP, data integrity (ALCOA+), and GxP documentation standards.
  • Competent in creating/reviewing technical documentation and qualification protocols in line with regulatory requirements.
Benefits:

Excellent analytical and problem-solving skills, with a methodical attention to detail. Proven ability to collaborate cross-functionally and interface confidently during audits and inspections.

Others:

Specialize in injectable product qualification (media fill, aseptic simulation, smoke studies). Oversee qualification of systems such as water, steam, HVAC, filling/sealing machines, autoclaves, isolators, washing tunnels/DHS units, and more.