21 Jan, 2025
DUTIES: • Approve equipment validations and qualification documents to ensure compliance with all applicable internal and regulatory standards. • Inform management of issues identified during qualification activities and recommends appropriate actions to address the issue(s). • Review impact analysis of changes to facilities and equipment. • Lead, facilitate, participate, and approve Risk Assessment. • Participate in the Change Control Process for changes to facilities, equipment, and instrumentation. • Perform Change Control Board approvals as the technical expert for equipment, facilities and instrument changes. • Drive continuous improvement/PPI to the site’s equipment and facilities qualification/validation program. • Review and update site procedures related to equipment and facilities as required. • Apply Good Manufacturing...
Biochemicals / Pharmaceuticals
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Thermo Fisher Scientific
Waltham, MA, USA
Process Engineer