Validation Engineer

Responsibilities: Develop URS, SIC and SRA for new and existing aseptic facilities and equipment. Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and according to specifications. Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions. Ensure all documentation is compliant with regulatory requirements and internal quality standards. Conduct risk assessments and implement mitigation strategies for aseptic processes. Ability to work closely and effectively with other workgroups to successfully complete projects on time and thoroughly. Work independently or within a team environment. Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the Company. Proficient in the use of word processing, spreadsheet, and presentation software programs. Proficient in use if Kaye Validator AVS and Val Probe Systems. Knowledge on following equipment qualifications: Homogenizers, Pump Skids, SIP & CIP Skids, Temperature control units Tanks, Requalification of CTU's. Develop and implement validation plans for computerized systems, ensuring that systems are compliant with regulatory standards and internal policies. Conduct risk assessments to identify potential issues related to system functionality and data integrity. Create and maintain comprehensive documentation, including system classification, system overview, test scripts, and reports that demonstrate compliance with regulatory requirements. Execute CSV protocol, to verify that systems function as intended. Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity. Excellent interpersonal skills. Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the company. Comprehensive knowledge of pharmaceutical manufacturing equipment and processes. Ability to work closely and effectively with other workgroups to successfully complete projects on time and thoroughly. Requirements: Bachelor's degree preferably in Engineering or Science discipline. 3 - 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment. Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs.

Created: 2026-04-02