Excel Engineering ยท 4 hours ago
Validation Engineer (KY)
Lexington,KY,US
Full-time
Onsite
Senior Level
5+ years expExcel Engineering is seeking a team-oriented, highly motivated Validation Engineer for our Lexington, Kentucky area. The role involves supporting projects, technical transfers, and ongoing validation maintenance across various disciplines such as facilities qualification and computerized systems validation.
Industrial AutomationIndustrial EngineeringProject Management
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
Qualification
Required
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
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
Ability to write and speak in the English language
Willingness to travel up to 10% of the time
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
Preferred
Engineer in Training (EIT) registration or ability to obtain such is highly preferred
Benefits
Competitive salary and benefits package
Company
Excel Engineering
Excel Engineering is an automation company that focuses on electrical, transmission, and IT/OT system engineering services.
51-200 employees
H1B Sponsorship
Excel Engineering has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
MICHAEL "RANGER" WILLIAMS
TRANSMISSION LINE INSPECTOR
Recent News
Seattle TechFlash
2025-04-03
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