Equipment Qualification Engineer
Newark Metro Area, NJ
Minimum 5 years experience in GMP laboratory or manufacturing environment / regulated industry required.
Minimum 2-3 years' experience working with and troubleshooting single use biologics manufacturing equipment, such as bioreactors, chrom skids, and tangential flow filtration skids.
Experience writing and supporting deviations and investigations preferred.
Experience working with quality systems, mainly Blue Mountain RAM preferred.
Ensures all calibration, PM, and qualification records are filed appropriately after approval.
Writes and supports deviations and investigations that result from qualification failures along with developing and supporting the implementation of corrective and preventative actions.
Support the development, revision and review of written procedures for calibration, preventive maintenance and requalification of equipment.
Support the development, review and approval of calibration and maintenance plans in site quality management system.
Addresses BEMS equipment alarms and ensures storage equipment maintains the appropriate set points.
Supports the execution of equipment qualifications and process improvement studies.
Adheres to all policies and procures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.