| Urgent Hiring on :: Validation Engineer QC & Analytical Software :: Hybrid, Boston, Massachusetts at Boston, Massachusetts, USA |
| Email: [email protected] |
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From: Sankhi Tudu, Vyze Inc [email protected] Reply to: [email protected] Position:Validation Engineer QC & Analytical Software Location: Hybrid, Boston, Massachusetts Duration: 6 Months MOI: Skype Responsibilities: Lead the upgrade, validation, and implementation of QC software systems, including but not limited to LIMS, Trackwise, Optel, Asset Management, and IQVIA. Ensure the compliance of all systems and processes with applicable regulatory standards (GxP, FDA, etc.). Manage and support data loggers, including calibration, maintenance, and troubleshooting. Provide technical expertise in Computer System Validation (CSV) and execute validation protocols, test scripts, and reports. Collaborate with cross-functional teams to implement QC software solutions that meet business and regulatory requirements. Identify and resolve issues related to QC instrumentation, software, and system performance. Maintain detailed documentation of system validations, configurations, and operational procedures. Support project implementations and system integrations across QC and operational teams. Required Skillset Qualifications: 5+ years of experience in QC instrumentation, software, and systems, with expertise in LIMS, Trackwise, Optel, Asset Management, IQVIA, or similar platforms. Strong knowledge of Computer System Validation (CSV) processes, QC software upgrades, and regulatory compliance requirements. Proven ability to troubleshoot and resolve technical issues related to QC systems and instrumentation. Experience working in a regulated environment (e.g., GMP, FDA, ISO) is required. Strong interpersonal and communication skills to effectively collaborate with cross-functional teams. support equipment-related tasks. Experience with any of the following instrumentation or software is highly desired: SD Tanks TruScan ALZ TruScan EQP Biomek i5 TCU Framingham Refrigerator New Agilent GC 7890 Coswin Slingshot - Server Commissioning - Glasswasher and Dryer QC Micro autoclave Genesys Spectrophotometer Small Parts / (4) UF DF Temp Mapping TCU Endoscan ENNOV Smoke Study MFG Genesys Spectrophotometer TrackWise Endoscan TruScan ALZ TruScan EQP Biomek i5 Agilent GC 7890 Commissioning - Glasswasher and Dryer QC Micro autoclave LIMS Genesys Spectrophotometer ENNOV Keywords: green card South Dakota Urgent Hiring on :: Validation Engineer QC & Analytical Software :: Hybrid, Boston, Massachusetts [email protected] |
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| 05:27 AM 08-Mar-25 |