*Location: Ft. Worth, Texas* *Duration: 6+*
*Rates: $45/hr* *Interview mode: Phone then F2F* *Job Purpose:* The Validation Engineer is responsible for developing and executing validation protocols related to system configuration of *a GxP document compliance management system and the migration of content from one GxP Documented environment to another, *as well as interfaces to other systems related to regulatory submissions and records retention. *Major Accountabilities:* •Develop performance validation protocols to test data migration processes and conduct GxP data verification •Develop operational and performance validation protocols to test system configuration modifications •Develop operational and performance validation protocols to test system interfaces •Fully test protocols prior to validation execution to eliminate script errors and minimize deviations •Coordinate with Project Quality Manager and Project Manager to develop protocols and discuss deviations •Execute validation protocols and complete deviation reports as required •Proof and check documents and records for data verification activities as required •Adhere to applicable procedures when developing and executing validation protocols •Communicate to Project Manager and Validation Coordinator any foreseeable issues when executing protocols •Perform administrative tasks as requested K*ey Performance Indicators:* •Timely and successful development of validation protocols to meet project objectives and schedule •Quality of documentation (# of script deviations) and communication •Successful execution of validation protocols that adhere to compliance SOPs *Minimum Required:* *•Experience developing and executing Operational Qualification (OQ) and Performance Qualification (PQ) Protocols in a GxP validation environment.* •Proficient in developing/utilizing test scripts in accordance with software technical requirements and compliance. •Proof reading skills Experience with computer systems. *Preferred Level:* *•Experience developing and executing OQ and PQ protocols related document management systems, preferably EMC Documentum Compliance Manager (DCM), within medical device/pharmaceutical/biotechnical industry. * *•Disciplines include R&D, QA, Regulatory Affairs Experience using electronic Quality System management tools.* •Proficient in utilizing Documentum and controlled document systems Familiarity with OmniRIM Records Management System Familiarity with Plateau Learning Management System Thanks Regards *Swami A* Technical Recruiter *Ennovace Inc* Ph: 214-541-9378 F: 972-262-9006 sw...@ennovace.com www.ennovace.com 1801 S O'connor Rd Irving TX 75061 In my absence please contact Steven at ste...@ennovace.com (214-541-9081) Disclaimer: We respect your Online Privacy. This e-mail message, including any attachments, is for the sole use of the intendedrecipient(s) and may contain confidential and privileged information.Any unauthorized review, use,disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line at rem...@ennovace.com and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. Thank you Regards *Swami A *Sr. Marketer Ennovace Inc Ph: 214.541.9378 F: 724.264.5637 sw...@ennovace.com www.ennovace.com 1801 S O'connor Rd Irving TX 75061 -- You received this message because you are subscribed to the Google Groups "Hot List" group. To unsubscribe from this group and stop receiving emails from it, send an email to directclienteq+unsubscr...@googlegroups.com. To post to this group, send email to directclienteq@googlegroups.com. Visit this group at http://groups.google.com/group/directclienteq. For more options, visit https://groups.google.com/d/optout.
