Hello,
Hope you are doing good.
ROLE: Sr CSV Equipment Validation Project Manager
LOCATION: Columbia, Missouri (Hybrid onsite)
Qualifications:
· Experience with Computer System Validation on Equipment Qualification projects
· Experience coordinating IQ/OQ executions with Equipment vendors and client IT departments
· Experience evaluating quotes from vendor for the purchase of any additional services (software installation, IQOQ, calibration, etc.)
· 9+ years of experience in Life Sciences industry – experience with validation of software in equipment
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Request and evaluate quotes from vendor for the purchase of any additional services (software installation, IQOQ, calibration, etc.)
· Request and evaluate vendor’s software offerings to ensure 21 CFR Part 11 compliance
· Contact equipment vendors to coordinate software installation and/or qualification dates
· Conduct periodic meetings with project team
· Prepare periodic status reports for project stakeholders
· Seek acceptance for deliverables
· Bring risks and issues to Eurofins BPT in an expedient manner
· Drive Change Management/Control/Orders
· Support with the authoring and execution of the following validation deliverables:
o Electronic Record/Electronic Signatures (ER/ES) revision for SOPs
o Release Notes Assessment
o Regulatory Impact Assessment
o System Validation Master Plan
o Risk Assessment
o Functional Requirements Specification Plan
o System Design Specification Plan
o Traceability Matrix
o Test Plan
o Test Scripts
o Validation Final Report Plan
· Responsible for suporting validation and implementation of the following equipment:
o Beckman Coulter CytoFLEX S
o Beckman Coulter Optima AUC
o Beckman Coulter Vi-CELL XR
o bioMérieux BACT/ALERT 3D Dual-T
o Bio-Rad QX200 AutoDG ddPCR
o ChemoMetec NucleoCounter NC-200
o PerkinElmer EnVision Multimode Plate Reader
o Thermo Fisher Scientific NanoDrop UV-Vis
o Agilent OpenLab CDS
o Bruker MPA II FT-NIR Spectrometer
o Meso Scale Discovery (MSD) Discovery Workbench
,
Sudheer D
Sr Recruiter
Master Compliance Inc.,
Email:
Ph:
Location: 9901 Valley Ranch Pkwy E, Suite 3001, Irving, TX 75063
Website: