Hi Partners,
Hope you are doing well. Please let me know if you have anyone for below mentioned positions with resume and following details of your consultant. Full Name/Phone/Email/Current Location/Availability/Rate Reply at as...@canbay.us for quick response *Requirement-1:* Position: Validation Engineer Location: Duluth GA Duration: 6-12+ months Job Description: The Validation Engineer will lead and/or assist validation efforts at clients R&D. The position will be responsible for preparing the validation strategy and guidance via the review, writing, and executing validation activities. The Validation Engineer will provide the coordination and execution of qualification and validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support R&D VC facilities. In addition Validation Engineer will have an understanding of how the various pieces of R&D equipment operate, and understand the principle of Validation and Engineering to ensure compliance with 21 CFR requirements and R&D VC policies and procedures. The position will require hands-on experience in all areas of validation including equipment qualification, performance qualification, process validation, cleaning validation, computer system validation, and facility utilities qualification. Skills: •§ Execution of validation plans and validation protocols for VC R&D projects that impact facility, processes, equipment, cleaning, and software systems. •§ · Prepare and /or revise validation protocols/procedures as required. •§ · Review and execute qualification and summary reports, write and revise as needed. •§ · Update the site master validation plan to reflect current validation status. •§ · Participate in review of R&D operational SOPs that apply to validated equipment, facilities and processes. •§ · Assist in troubleshooting, complex or usual problems arising from equipment/system failures. •§ · Ensure continuous validation maintenance for equipment, facility and process through the change control program. •§ · Analyze validation data, prepare reports, and make recommendations for changes and or/improvements. •§ · Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity. •§ · Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity. •§ Utilize Windchill system to maintain and approve validation documentation Education: •· BS degree in Mechanical, Electrical Engineering or Chemistry (Master's degree preferred) •· Fluency in English essential •• 3 - 5 years of direct experience in the validation of medical device or pharmaceutical equipment and processes. •• Solid technical understanding of medical device operations. •• Strong written and verbal communication •• Good knowledge of 21CFR and ISO 13485 quality systems requirements and current industry practices. •• Understanding of computerized system validation, GAMP 5 requirements, USP 1058 Analytical Instrument Qualification. •• Demonstrate ability to work in a cross-functional team environment. •• The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules. •• Proficient in Microsoft Word, PowerPoint and Excel required. •Working knowledge of Windchill *Requirement-2:* Position: Validation Engineer Location: Memphis, TN Duration: 12+ months *Interview: Phone, then Face to Face (they must be able to interview on-site, so they prefer local candidates)* *Skills Required:* ·Conducting calibrations on equipment ·Metrology ·Validation ·Writing procedures, updating SOPs ·Experience with medical device, automotive or another highly regulated industry Education: BS degree minimum * Thanks & Regards,* *Ashok Kumar* *XL Impex Inc* *Canbay Technology Solutions; *http://www.canbay.us *5 Independence Way, Suite 300, Princeton, NJ 08540* *Email **as...@canbay.us <as...@canbay.us>* *Phone: 609-454-0103* *Fax: 973 577 6989* -- You received this message because you are subscribed to the Google Groups "International SAP Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to international-sap-projects+unsubscr...@googlegroups.com. To post to this group, send email to international-sap-projects@googlegroups.com. Visit this group at http://groups.google.com/group/international-sap-projects. For more options, visit https://groups.google.com/d/optout.
