Validation Engineer (KY)
At Excel Engineering, we are the power behind our clients’ processes.
We are a full-service engineering consulting firm specializing in electrical engineering, industrial automation, and power systems. For over 30 years, we’ve partnered with leading companies across industries to deliver solutions that improve safety, efficiency, and performance.
Our work spans sectors including life sciences, consumer goods, chemical, oil & gas, and utilities, giving our team the opportunity to work on complex, high-impact projects.
What sets us apart is our approach, we build long-term partnerships by understanding our clients’ operations and acting as an extension of their team. If you’re looking to grow your skills, take on meaningful challenges, and make a real impact, Excel Engineering offers the opportunity to do just that.
We are seeking a Validation Engineer to support projects, technical transfers, and ongoing validation maintenance including, but not limited to, the following major disciplines:
- Facilities, Utilities, and Equipment (FUE) Qualification
- Computerized Systems Validation (CSV)
- Cleaning Validation
- Sterilization Validation
- Materials Validation
- Process Validation
Primary Responsibilities
- Develop, execute, and review validation deliverables including Validation Plans and Reports, User Requirements Specifications, Risk Assessments, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Standard Operating Procedures, and Validation Maintenance packages.
- Perform data collection, analysis, and resolve deviations or non-conformances identified during validation activities.
- Author SOP updates and revisions related to processes, equipment and system modifications.
- Maintain compliance with company policies, cGMPs, regulatory requirements, and safety protocols.
- Operate and program instruments (e.g., temperature/humidity dataloggers) for controlled temperature/humidity chamber qualifications (e.g., lyophilizers, warehouses, sterilizers, incubators).
- Collaborate with engineering, quality, manufacturing, and regulatory teams to ensure successful project execution.