Job Summary
A talented Validation Engineer is sought to support quality assurance and regulatory compliance in a sterile fill finish facility.
The ideal candidate will have extensive experience in CQV activities, with a strong background in GMP-compliant environments and pharmaceutical/biotech projects.
Key Responsibilities:
* Develop and execute comprehensive validation protocols, including FAT, IV, FT, SAT, and PQ test documentation.
* Review and approve validation protocols and qualification summary reports (QSRs).
* Contribute to the development of Validation Master Plans, SOPs, and Quality Risk Assessments.
* Assist in resolving deviations, exceptions, and root cause analysis.
* Compile and report on validation metrics, driving continuous improvement initiatives.
Requirements:
* Minimum 6 years of experience in Engineering or Validation.
* Degree in Engineering or relevant technical qualification.
* Substantial expertise in CQV activities for pharmaceutical/biotech projects.
* Proven track record working with sterile/biotech equipment in GMP-regulated settings.
* Familiarity with risk-based validation approaches and paperless qualification systems is advantageous.