Equipment Validation

3 days ago

Kolkata, India Tek Support Full time

Job Title: Trainer – Equipment Validation

Experience: 10+ years

Location: Remote



Position Overview:

We are seeking an experienced Equipment Validation Trainer to deliver comprehensive training programs on equipment qualification and validation processes in regulated industries. The ideal candidate will have deep expertise in IQ/OQ/PQ execution, equipment lifecycle management, and regulatory compliance , with proven ability to train cross-functional teams in pharma, biotech, and medical device environments.


Key Responsibilities:

  • Design and deliver training modules on equipment validation and qualification (IQ, OQ, PQ).
  • Train participants on URS/DQ preparation , risk-based approaches, and validation planning.
  • Provide guidance on protocol and report writing , ensuring alignment with cGMP, FDA, and EMA requirements.
  • Deliver training on calibration integration , traceability, and maintaining equipment accuracy.
  • Educate teams on deviation handling, CAPA management, and change control processes.
  • Coach participants on cGMP compliance and industry best practices in equipment lifecycle management.
  • Conduct workshops on validation documentation, audit readiness, and regulatory inspections .
  • Provide practical, case-based training using examples from the medical device, pharma, and biotech industries.


Required Skills & Expertise:

  • Strong knowledge of IQ/OQ/PQ execution and equipment qualification.
  • Hands-on experience with URS, DQ, validation planning, and execution .
  • Proficiency in protocol/report preparation and documentation practices .
  • Familiarity with calibration systems and integration with equipment validation.
  • In-depth knowledge of cGMP, FDA, EMA, and ICH regulatory expectations .
  • Experience in deviation management, CAPA, and audit compliance .
  • Excellent training, presentation, and communication skills.

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