Validation Engineer (KY)

Description

Excel Engineering is seeking a team-oriented, highly motivated Validation Engineer for our Lexington, Kentucky area. We offer full-service Engineering Consulting services in the US and abroad.  

Since 1990, Excel Engineering has differentiated its services from that of its competition by providing engineering solutions to achieve our clients’ business objectives.  

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.  

Requirements

Education and Experience  

• Bachelor's degree in science, engineering or other related technical field from an ABET Accredited Institution such as Chemical Engineering, Mechanical Engineering, Computer Engineering, or Electrical Engineering.  
• Cumulative GPA of 3.0 or higher on a 4.0 Scale.  
• 5 years of related experience.  

Qualifications  

• Experience applying cGMP principles to equipment, facility, utility, laboratory, and computer systems.  
• Experience supporting commissioning and qualification of major capital projects or facility start-ups.  
• Engineer in Training (EIT) registration or ability to obtain such is highly preferred.  
• Ability to write and speak in the English language.  
• Willingness to travel up to 10% of the time.  

Additional Skills Applicable to the Role  

• Excellent interpersonal skills, as well as verbal and written communications.  
• Ability to work collaboratively with individuals at all levels in the organization in a team environment.  
• Knowledge of relevant technical software.  
• Knowledge of MS Office software products: Word/Excel/Outlook. 

We offer…

• Growth & Development: Ongoing continuing education, hands-on training, and opportunities to expand your skills.

• Career Advancement Support: Assistance in earning professional certifications and pursuing further education.

• Retirement Benefits: 401(k) plan with employer matching.

• Comprehensive Health Coverage: Medical, dental, vision, and life insurance options.

• Wellness Focus: Access to programs designed to support your overall well-being.

• Work–Life Balance: Paid time off and flexible work environment

• Flexibility & Trust: A flexible schedule and work environment built around mutual trust and accountability.

• Share the Talent, Share the Rewards: We value great people recommending great people, which is why our employee referral program is designed to reward you continuously

We offer a competitive salary and great benefits. At Excel Engineering, we’re proud of our positive, high-performing culture where teamwork, continuous improvement, and a service-oriented mindset help us do our best work every day. If you enjoy a fast-paced and rewarding environment, you’ll love being part of our team!  

Excel Engineering, Inc. is proud to be an Equal Opportunity Employer. We welcome and consider all qualified applicants without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, or any other protected characteristic.

We value diverse perspectives and believe they strengthen our work, our teams, and the solutions we deliver to clients. We encourage candidates from backgrounds traditionally underrepresented in engineering to apply. If you need accommodations during the application or interview process, please contact our Human Resources team at ExcelHR@exceleng.net.