Job Information
ND Global Consulting Services Inc. Validation Engineer in Mckinney, Texas
[Validation Engineer needed w/Masters degree or Foreign Equivalent in Mechanical Engineering or Engineering Management or [Pharmaceutical Sciences[ and one (1) year as Validation Engineer or Manufacturing Engineer performing following job duties: [Author Validation protocols, standard operating procedures (SOPs) and Validation reports incorporating ALCOA principles in adherence to company guidelines as recommended by USFDA. Execute validation testing on Controlled temperature units and computer systems. Provide application of experimental design concepts to process development optimization and robustness studies. Develop acceptance criteria consistent with industry standards, manufacturer recommendations, user, functional specifications and current Good Manufacturing Practices (cGMP). Participate in the risk assessment related to the project and guide the team in risk management approaches and systems. Perform the development of validation protocols, the development of validation studies, data analysis and compilation of the data and results into final reports in GMP compliant formats. Review protocols and CandQ Plans, determine the validation approach, the required qualifications, the sampling plan and ensure the follow-up and track the validation's activities of the group. Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and operation of the system. [Benefits: Health Insurance and PTO. [Job Locations: [McKinney[, TX or unanticipated client sites within the U.S. [Must be available to travel and relocate to unanticipated client sites for temporary projects. [Travel to client locations in the USA is based upon projectlength. Upon project completion, travel is required to the next client site. [The occupation is only required to travel to National which is McKinney, TX or unanticipated client sites within the U.S based on the project length, there is no International Travel Required.[ [Mail Resumes to: [ND Global Consulting Services, Inc. [3721 South Stonebridge Drive, #1101, McKinney, TX 75070 ]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}]{bookman="" old="" style",serif"=""}