Hi,
This is Nick from Lorven Technologies, Our Client is looking for a *Computer System Validation *for a *Contract *Position in*Menlo Park, CA .*Below is the detailed requirement. *Position: Computer System Validation* *Location: Menlo Park, CA* *Duration: Contract* *Rate: $60 - $65/hr * *Experience Required: 10 - 12 Years* *Job Description:* Computer System Validation - Someone that is knowledgeable in Computer System Validation within the medical device focused in the areas of CSV remediation, CSV Validation & development of Training Material. While our devices do not contain software as we introduce new equipment or enterprise software they will need to be validated and demonstrate SOX and Part 11 compliance. *A successful candidate will have the following minimum qualifications:* · Bachelor’s Degree · Professional experience in a medical device manufacturing and product development environment · A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971 and the EU Medical Device Directive. · Excellent verbal (including presentation) and written communication skills, especially technical writing · The ability to work effectively on project teams · Minimum 10-12 years’ experience in Computer System Validation with software and laboratory equipment in medical device or pharmaceutical industry · Experienced in performing GAP assessments and conducting CSV remediation · Experienced in developing training materials, SOPs, Work Instructions and Technical writing · Experienced in validating ERP and larger enterprise systems (SAP, ORACLE etc..) · Experienced in supporting base business validation activities (i.e. change control review and approval, document review and approval, UAT, System Testing) · Ability to independently author, review and approve validation deliverables (Validation Plan, User Requirement Specifications, Functional Requirement Specifications, Installation Qualification, Operation Qualification, Performance Qualification etc.) · Understand and apply GAMP-5 and other industry standards to risk based validation of computer systems · Experience with SharePoint or technical configuration of other software systems is preferable · Experience with JNJ SDLC methodology is a preferable *Thanks & Regards,* *Nick* *Lorven Technologies Inc, * 101, Morgan Lane, Suite 209, Plainsboro, NJ-08536 Direct :609-681-5308 |Work : 609-799-4202 Ext 235 | Fax: 609-799-4204 Email: [email protected] <[email protected]>| Web: www.lorventech.com -- You received this message because you are subscribed to the Google Groups "Open Source J2EE frameworks" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/open-source-j2ee-frameworks. For more options, visit https://groups.google.com/d/optout.
