Validation Specialist - Aseptic Operations
Overview
Lead validation activities across sterile environments ensuring compliance with FDA EMA Annex 1 regulations. Drive performance impact on site success and customer satisfaction.
What You'll Do9
- 1Develop and execute IQ/OQ/PQ protocols for utilities and equipment
- 2Conduct risk assessments identifying critical parameters
- 3Install new manufacturing equipment and support capital expansions
- 4Analyze validation data and prepare reports
- 5Review protocols and collaborate with QA engineering teams
- 6Act as SME during regulatory audits
- 7Support investigations of deviations and non-conformances
- 8Ensure alignment with GAMP5 and ISPE guidelines
- 9Propose improvements to validation programs based on industry trends
Requirements5
- 1Bachelor's degree in Engineering or Life Sciences
- 2Minimum 3 years validation experience in sterile manufacturing
- 3Experience with Steam and VHP sterilization processes
- 4Knowledge of ISO 5 isolators and cleanroom validation
- 5Proficiency with Microsoft Office suite
Salary Insight
$45k per year
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