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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Validation Engineer

Tampa, FL

Full-time

Onsite

Senior Level

5+ years exp

Kelly Science, Engineering, Technology & Telecom is seeking a Validation Engineer to support the validation of manufacturing and packaging equipment in compliance with regulatory guidelines. The role involves developing validation protocols, managing projects, and ensuring compliance with cGMP standards.

Staffing & Recruiting

Responsibilities

Develop sound scientific rationale/strategy for commissioning and qualification of new or modified cGMP environment, equipment and processes

Design, implement and execute protocols to validate manufacturing equipment, facilities and utilities in a manufacturing environment following the latest cGMP regulations

Partner with Engineering to develop/execute commissioning

On-site support of validation, qualification and requalification activities at the Tampa site

Management of multiple projects and requalification effectively

Participate in continuous improvement projects related to validation programs and procedures

Evaluate test data and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity

Able to don cleanroom garments and enter aseptic manufacturing as required for job responsibilities

Suggest and Participate in CI/CIP/compliance related projects

Communicate the requirements, scheduling, results and impact of the performance of the above projects to ensure efficient and successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical product

Ability to run multiple projects and coordinate personnel

Qualification

Validation experienceCGMP complianceComputer System ValidationUtilities validationSterilization processesTemperature-controlled equipmentContinuous improvementProject managementCommunication skills

Required

Minimum 5 years of Engineering or Validation experience

Preferred

Experience in the following types of validation is desired: Utilities, facilities, manufacturing equipment (compounding, filling, and packaging), sterilization processes including moist heat, dry heat, gamma, e-beam, x-ray and ethylene oxide; Media Fills, temperature-controlled area/equipment

Computerized systems/SQA experience is a plus