Job 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 a competitive salary and benefits package.

Excel Engineering is focused on cultivating a high performing culture where a service oriented approach, continuous improvement, and goal orientation are valued. If you enjoy working in a fast paced, challenging and rewarding environment, Excel Engineering is for you!

Excel Engineering is an Equal Opportunity Employer. Applicants will receive consideration for employment regardless of their race, color, religion, national origin, sex, sexual orientation, disability, age, veteran status, marital status, or status with regard to public assistance.

In our commitment to diversity, equity, and inclusion, we strongly encourage applicants from populations that are underrepresented in the engineering field to apply. For applicants who need an accommodation to apply, please contact human resources at ExcelHR@exceleng.net