We are seeking an experienced Validation Engineer to support Critical Quality Verification (CQV) activities in a sterile fill finish facility.
Key Responsibilities
* Develop, execute, and approve CQV test documentation including Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Site Acceptance Testing (SAT).
* Pre-approve and post-approve validation protocols and qualification summary reports.
* Contribute to the development of Validation Master Plans, Standard Operating Procedures (SOPs), and Quality Risk Assessments.
* Assist with root cause analysis, deviations, and exceptions resolution.
* Gather and report on validation metrics, supporting continuous improvement efforts.
Requirements
* At least 6 years of experience in Engineering or Validation.
* Degree in Engineering or relevant technical qualification.
* Strong background in CQV activities for pharmaceutical/biotech projects.
* Experience with sterile/biotech equipment in a Good Manufacturing Practice (GMP)-regulated setting.
* Familiarity with risk-based validation approaches and paperless qualification systems is desirable.