Lead-msat (validation)

Julphar Net Corp

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Gmp documentation and data integrity
Validation lifecycle using v-model
Critical utilities validation
** Julphar Net Corp is seeking a Lead for their Manufacturing Science and Technology (MS&T) activities, focusing on validation processes, compliance, and technical support for commercial manufacturing. The role requires extensive experience in GMP environments and strong leadership skills to oversee validation documentation, process validation, and compliance with regulatory standards. **

Job Summary

  • Lead MS&T activities supporting commercial manufacturing, technology transfer, and site readiness, acting as the technical bridge between departments.
  • Ensure compliance with GMP documentation and data integrity requirements, maintain validation master plans, and support robust scientific understanding of manufacturing processes.
  • Lead or support investigations related to process deviations, perform root cause analysis, and propose technically sound CAPAs and process improvements.

Matching Summary

Match Score: 75

** Julphar Net Corp is seeking a Lead for their Manufacturing Science and Technology (MS&T) activities, focusing on validation processes, compliance, and technical support for commercial manufacturing. The role requires extensive experience in GMP environments and strong leadership skills to oversee validation documentation, process validation, and compliance with regulatory standards. **

Skills & Requirements

Must-have

  • GMP documentation and data integrity
  • Validation lifecycle using V-Model
  • Critical utilities validation
  • Cleanroom qualification ISO-14644
  • Process validation new and existing products
  • Aseptic process simulation media fills
  • Computerized System Validation CSV

Nice-to-have

  • Result-oriented with ownership
  • High compliance adherence
  • Strong initiative and flexibility
  • Excellent communication and collaboration
  • Effective task and workload management

Key Requirements

  • Bachelor’s degree in pharmacy, Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, or related scientific discipline
  • Minimum 6–10 years of experience in pharmaceutical manufacturing
  • Extensive hands‑on experience in qualification and validation activities
  • Strong knowledge of cGMP, SFDA, WHO, EU GMP, and ICH guidelines
  • Proven experience in validation of manufacturing equipment, critical utilities, and cleanrooms
  • Hands‑on experience in IQ, OQ, PQ, and FAT/SAT execution
  • Strong experience in process validation, cleaning validation, sterilization validation, and aseptic process simulation
  • Solid experience in Computerized System Validation (CSV)

Work Rights

Not specified

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