Hi,
We are looking for *Validation Engineer *in *Hopewell, NJ *for *6+ months * project. *Location:* Hopewell, NJ *Duration:* 6 Months *Job Requirements: * 6+ years experience • Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes • Follow SOPs and industry best practices • Conduct training on good documentation and good testing practices • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system • Review validation deliverables for projects which are contracted to third party suppliers • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues • Assist in planning, implementing, and documenting user acceptance testing • Review computerized systems validation documents such as: o Requirements Specification o Design Specification o CSV Risk Assessment o Test Plans o Test Summary Reports o Data Migration Plan o Pre/Post Executed Test Scripts o Traceability Matrix o Release to Production Statements • Direct and review testing • Provide guidance on quality issues that affect the integrity of the data or the system • Prepare validation summary and test summary reports • Obtain and respond to QA review • Participate in establishing standard quality and validation practices • Independently assess compliance practices and recommend corrective actions • Approve validated computer system related change requests • Monitor regulatory and inspection trends and advise the business on suitable action GCP experience preferred. *Send matching candidate with contact #, rate and availability date to [email protected] / [email protected] *** * * *Keyur Patel* *cyberThink, Inc* 1125 US Hwy 22, Suite 1 Bridgewater, NJ 08807 Phone: (908) 429-8008 ext. 354 Cell: 908-875-3692 Fax: (908) 429-8004 Email: [email protected]* * Website: www.cyberThink.com <http://www.cyberthink.com/> Gmail: [email protected] http://www.linkedin.com/in/keyurct -- Subscription settings: http://groups.google.com/group/tek-professionals/subscribe?hl=en
