Equipment Validation Engineer

ALLIANCE BIOTECH SOLUTIONS LLC • Raleigh, NC

5d

About The Position

Alliance Biotech Solutions has multiple openings for Validation Engineers to support the execution and coordination of commissioning, qualification, and validation (CQV) activities for new and existing equipment within a GMP-regulated CDMO environment. These roles will focus on the introduction of new process equipment and updates to existing systems, ensuring all validation activities are executed in compliance with FDA, GMP, and global regulatory standards.

This Validation Engineer will work cross-functionally with Manufacturing, Quality, Engineering, and Automation teams to support equipment qualification, system integration, and potential CSV activities. The role requires strong technical writing, analytical thinking, and hands-on execution to ensure compliant, efficient project delivery within aggressive timelines.

Requirements

• 2+ years (mid-level) or 5+ years (senior) of experience supporting CQV/validation activities in GMP-regulated environments
• Experience with equipment qualification (IQ/OQ/PQ) for manufacturing and/or lab systems
• Exposure to single-use technologies and/or biopharmaceutical manufacturing environments preferred
• Experience with CSV and data integrity concepts is a plus
• Strong understanding of GMP regulations and global compliance standards
• Ability to interpret technical documentation including P&IDs, URS, 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 fast-paced project environment
• Strong communication skills with the ability to collaborate cross-functionally

Nice To Haves

• Exposure to single-use technologies and/or biopharmaceutical manufacturing environments
• Experience with CSV and data integrity concepts

Responsibilities

• Execute and support equipment qualification activities including IQ/OQ/PQ protocol development, execution, and report generation
• Support validation efforts for single-use systems including single-use mixers (SUMs), process pumps, and filtration systems (SUTFF)
• Participate in the qualification of lab instruments such as cell viability analyzers (e.g., Vi-Cell BLU) including potential CSV/data integrity support
• Perform on-the-floor validation execution including system walkdowns, functional testing, and coordination with operations
• Support system integration activities, ensuring equipment and instrumentation operate within defined parameters
• Assist with updates and modifications to existing systems, including parameter and instrumentation changes
• Investigate deviations, discrepancies, and non-conformances; perform root cause analysis and support corrective actions
• Ensure timely closure of validation deliverables and associated documentation
• Collaborate with cross-functional teams to align validation activities with project timelines and operational priorities
• Author and review validation protocols, reports, and technical documentation
• Support execution within electronic validation and quality systems (e.g., KNEAT, TrackWise, Veeva or similar)

Benefits

• Competitive wage as a full-time employee
• Paid Time Off
• Dental and Vision Insurance with low employee cost
• paid long term and short-term disability
• 401K plan with employer contributions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed