Validation Engineers
QAVAENG CONSULTING - Carolina, PR

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QAVAENG continues expanding its operations and is currently searching for qualified individuals with Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams. Enhanced skills in leading, influencing and negotiating.

FUNCTIONS: Provide solutions to a variety of technical validation problems of moderate scope and complexity. Under general supervision will evaluate, select and apply standard validation engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete routine technical tasks. Function as a technical validation expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex validation problems. Routinely audit the validation status and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Work with manufacturing, maintenance, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for system modifications. Work under the direct supervision of project managers to complete the validation responsibilities of engineering, and construction projects within schedule and budget constraints. Generate rudimentary project cost estimates and schedules. Prompt and regular attendance to the workplace. Other functions may be assigned.

REQUIREMENTS: Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience. Working knowledge of validation processes and programs. Familiarity with pharmaceutical/biotech processes. Familiarity with documentation in a highly regulated environment. Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and apply GLPs and GMPs. Ability to apply validation engineering to production. Able to develop solutions to routine technical problems of limited scope.


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