EBM Validation Engineer
This is Nagaraj from Axius Technologies, One of my clien is looking for "EBM VALIDATION ENGINEER"
JOB TITLE : EBM VALIDATION ENGINEER
LOCATION : SOCIAL CIRCLE, GA (NEAR ATLANA)
DURATION : 12 MOTHS CONTRACT
Client is implementing Electronic Batch Management (EBM) for its BioScience pharmaceutical plant and needs Computer System Validation Technical with experience in Manufacturing Execution Systems (MES) for Validation and configuration of their EBM system.
MANDATORY EXPERIENCE AND DOMAIN:
* Minimum 3 years of experience in Validation of Pharma MES system in accordance with Quality Standards and Practices.
* Experience in computer system validation in implementation of one of the MES package implementation, preferably in Electronic Batch Management (EBM) system
* Experience in documenting test cases system and integration testing
* Experience with IQ, OQ and PQ in Pharmaceutical domain
* Experience in implementing Electronic Batch Records, computerized weighing, packaging systems etc.
* Excellent written and verbal communication skills
* Must be able to support the qualification process of Electronic Batch Record Management system.
* Sound understanding of regulations and methodologies associated with Pharma sector like 21CFR11, cGMP and S88
* Experience with atleast one of Siemens XFP, Camstar, Werum or Syncade
* Experience dealing with OracleDatabase in Enterprise and Shop floor networks
* The EBM Validation Lead would be responsible for test and validation of the Siemens XFP MES system and lead the validation effort with a team of local as well as geographically separated support team
* Generate Validation Package deliverables including Validation Plan, Qualification documents for EBM software following cGMP, FDA and otherquality standards and processes
* The consultant would report to Wipro project manager for EBM
* The Lead would also manage a small team for the validation manage coordination between remote US team and a team in India
* The job would involve interacting with various customer team including supply chain, quality assurance and process and manufacturing experts