Equipment Validation
2 days ago
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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