Edison, New Jersey, USA
6 days ago
Metrology Specialist

The technician will be responsible for a variety of tasks related to laboratory and manufacturing instrumentation and equipment, as well as managing and overlooking equipment, supporting change requests and completing change request activities in a timely manner.

Technicians will Support the equipment enrollment process for life cycle documentation of laboratory equipment, manufacturing equipment, TR&D, and MS&T equipment.

Contacts vendors, when needed, and coordinates their activities.

This position is 1st shift. Hours are 8AM to 5PM EST. Monday- Friday

The technician will perform a wide variety of tasks which will include the following:

Responsible for effective and efficient calibration to ensuring compliance with Novartis quality standards and applicable cGMP regulations. Responsible for equipment maintenance, diagnostics and repair in a cGMP regulated environment. Responsible for maintaining the calibration schedule for all equipment and instruments on site. Facilitate instrumentation calibration/qualification with external vendors, internal and/or external resources and local system owners. Ensure compliance to cGMP, regulatory regulations and Novartis global and local policy for equipment. Assistance field execution of various qualification protocols, prepares summary reports, co-ordinates report review and approvals with various Users and QA Compliance. Ensure compliance to cGMP, regulatory regulations and Novartis global and local policy for laboratory equipment. Develop / review appropriate SOPs and corresponding forms. Responsible for performing all assigned activities within budget and schedule constraints. Ensure communication flow in the Analytical Service team and with all individual involved in the process unit. As subject matter expert, provide support during audit and inspections. Maintain calibration of all manufacturing and QC equipment.
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