Validation Engineer

perengo inc. (
Computers/Information Technology


  Full Time   Employee

Santa Ana
United States

Hi We have an urgent requirement for a Validation Engineer . This is a Contract position based in Irvine, CA. If you are interested in this position, please contact me / send your updated resume. Job Title Validation Engineer Relevant Experience(in Yrs) 4-6 Year Technical/FunctionalSkills 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 activities/documentation versus project timeline. Write/review C 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 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. Education Mechanical/Electro Mechanical/ Bio-medical Engineering Duration of assignment (in Months) 1 year Work Location (State, City and Zip) Irwindale, CA 91706

Related Job Experiences: Software Development Engineer | Software Systems Engineer | Information Architect | Automation Engineer | Server Engineer | Mainframe Systems Programmer | Information Technology Analyst (IT Analyst) | Test Engineer |
Applicable Commuter Area of Irvine

To apply for this job, contact:
Mike Kofi Okyere

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