Validation Engineer

Alliancebiotechsolutions; Raleigh (NC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Industry competitive wage

Flexible Paid Time Off

Medical, Dental and Vision Insurance

Employer paid long term and short-term disability

401k plan with employer contributions

Job summary

Alliance Biotech Solutions is hiring a Cleaning Validation Engineer in Raleigh, North Carolina. This full-time role involves overseeing cleaning validation activities in GMP-regulated environments, including protocol development, deviation management, and documentation. Candidates should have over 2 years experience in this field, proficiency with electronic validation systems like KNEAT, and strong analytical and writing skills. The position offers a competitive salary along with flexible paid time off and comprehensive medical benefits.

Qualifications

• 2+ years of experience supporting cleaning validation in GMP-regulated environments.
• Strong understanding of GMP regulations and global compliance standards.
• Ability to interpret technical documentation including P&IDs and process flow diagrams.

Responsibilities

• Execute and support cleaning validation activities, including protocol development and execution.
• Collaborate with cross-functional teams to ensure validation activities align with project timelines.
• Author and review validation protocols, reports, and technical documentation.

Skills

Cleaning validation

Technical writing

Analytical thinking

Problem-solving

Cross-functional collaboration

Tools

KNEAT

Job description

Alliance Biotech Solutions is currently hiring multiple Cleaning Validation Engineers to supports the execution and coordination of cleaning validation activities across manufacturing equipment and processes in GMP-regulated environments. This role is responsible for protocol development, execution, deviation support, and documentation while ensuring compliance with site procedures, FDA, GMP, and global regulatory standards.

The Cleaning Validation Engineer will work cross-functionally with Manufacturing, Quality, Quality Control and Engineering teams to support the cleaning validation, including cycle development, hold time studies, and lifecycle management. The role requires strong technical writing, analytical thinking, and hands-on execution.

Requirements

Key Responsibilities

• Execute and support cleaning validation activities, including protocol development, execution, and final report generation
• Support Cleaning Validation, Clean Hold Time (CHT), and Soil Hold Time (SHT) studies from planning through completion
• Perform on-the-floor validation execution, including sampling and coordination of cleaning activities
• Support cleaning validation for manufacturing equipment including process vessels, CIP systems, autoclaves, and parts washers
• Investigate deviations, discrepancies, and out-of-specification results; perform root cause analysis and support corrective actions
• Ensure timely closure of validation-related deviations and documentation
• Collaborate with cross-functional teams to ensure validation activities align with project timelines and operational needs
• Author and review validation protocols, reports, and technical documentation
• Support execution within electronic validation systems such as KNEAT

Skills & Experience

• 2+ years of experience supporting cleaning validation in GMP-regulated environments
• Experience with electronic validation systems such as KNEAT or similar platforms
• Strong understanding of GMP regulations and global compliance standards
• Ability to interpret technical documentation including P&IDs and process flow diagrams
• Strong technical writing and documentation skills
• Demonstrated analytical and problem-solving capabilities
• Ability to work independently and manage multiple priorities in a dynamic environment
• Strong communication skills with the ability to collaborate cross-functionally

Benefits & Compensation

• Industry competitive wage as a full-time employee
• Flexible Paid Time Off
• Medical, Dental and Vision Insurance with low employee cost
• Employer paid long term and short-term disability
• 401k plan with employer contributions

About Alliance Biotech Solutions

Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.