Low Iq Jobs in Raleigh, NC (NOW HIRING)

Description

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

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)

Experience/Skills

  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

Benefits & Compensation

 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

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.