Validation Engineer - Sterile Fill Finish
We are looking for an experienced Validation Engineer to support CQV activities for in a sterile fill finish facility. This is a fantastic opportunity to work in a GMP-compliant environment, ensuring validation activities meet quality and regulatory requirements.
Key Responsibilities:
✔ Develop, execute, and approve CQV test documentation (FAT, IV, FT, SAT, PQ).
✔ Pre-approve and post-approve validation protocols and qualification summary reports (QSRs).
✔ Input into Validation Master Plans, SOPs, and Quality Risk Assessments.
✔ Assist with root cause analysis, deviations, and exceptions resolution.
✔ Collate and report on validation metrics and support continuous improvement.
Requirements:
✔ 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 GMP-regulated setting.
✔ Familiarity with risk-based validation approaches and paperless qualification systems is a plus.
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