*Job Title* Validation Engineer
*Relevant Experience* *(in Yrs)* 6 Year *Technical/Functional Skills* - Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211, ICH guidelines and other international regulatory requirements. - HVAC system Commissioning, control facilities temperature and relative humidity mapping, facilities Qualification and Validation activities. - Scheduling, planning and execution of validation projects for plant utilities, facilities and process equipment. - Apply thorough understanding of cGXPs, relevant plans and SOPs, routine project procedures, project management activities as appropriate. - Plan Commissioning & Qualification activities and track execution of C&Q activities/documentation versus project timeline. - Write/review C&Q plans, study/test protocols, and summary reports. Manage execution of study/test protocols and review test results. Commissioning and qualification protocol execution, and manage protocol deviations, investigation and corrective action activities - Have excellent analytical skills with systematic approaches to problem solving. - Demonstrate ability to comprehend mechanical/electrical drawings and related engineering prints for C&Q activities. - The position requires a combination of sedentary work and walking around the cGMP manufacturing facility. *Experience Required* Medical devices and process validation experience *Roles & Responsibilities* Validation Engineer *Generic Managerial Skills* - Ability to communicate effectively at all levels in verbal and written form, including technical/business writing. - Proficient in Microsoft Word and Excel, Project and other desktop computing software. - Able to establish and manage multiple cross-functional teams. - Project management experience preferred. *Start* *date* (dd-mmm-yy) ASAP *Duration of assignment *(in Months) 1 year *Work Location* (State, City and Zip) Irwindale, CA 91706 *Regards,* *Atul Sharma* *IT -recruiter* [email protected] <[email protected]> *Direct: 408.418.5778 EXT 3033* -- You received this message because you are subscribed to the Google Groups "only.SAP" 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 https://groups.google.com/group/onlysap. For more options, visit https://groups.google.com/d/optout.
