Job Description
Requirements:- Support cleaning validation activities, protocol execution, sampling, and documentation.
- Perform temperature mapping and requalification of controlled temperature units.
- Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
- Support commissioning, installation, and qualification of new or modified equipment.
- Assist with equipment troubleshooting alongside Engineering and Operations.
- Generate validation documentation following cGMP, GDP, and SOP requirements.
- Support validation lifecycle activities, change controls, investigations, and CAPAs.
- Participate in audit readiness and regulatory inspection support.
- Bachelor's degree in Engineering, Life Sciences, or related discipline required.
- 5+ years of hands-on validation experience with GMP equipment and utilities.
Skills
Biologyunmatched
Change Controlunmatched
Commissioningunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
GMP (Good Manufacturing Practices)unmatched
Identify Issuesunmatched
Process Validationunmatched
Regulationsunmatched
Standard Operating Procedures (SOP)unmatched
Temperature Mappingunmatched
Validation Documentationunmatched
Validation Planunmatched
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