QA Validation Engineer

Job Description: 

VEQTOR is seeking a highly detail-oriented TrackWise Change Control Specialist to join our team. This position is a full-time on-site role located in Round Lake, Illinois. The ideal candidate will be responsible for managing and coordinating change control processes within the TrackWise system, ensuring compliance with applicable regulations, internal policies, and industry best practices. This role also requires strong equipment validation expertise—including the ability to write protocols, troubleshoot, execute testing—and excellent technical writing skills to produce clear, accurate, and compliant documentation for regulatory and operational use. 

Main Responsibilities: 

• Serve as the primary TrackWise system administrator for change control processes. 
• Initiate, route, and track change control requests within TrackWise, ensuring timely progression through each phase. 
• Collaborate with cross-functional teams (Quality, Manufacturing, Engineering, Regulatory, Validation, etc.) to ensure accurate and complete documentation of changes. 
• Review and approve change control records for accuracy, completeness, and compliance with cGMP, FDA, EMA, and other applicable regulations. 
• Develop, write, review, and execute equipment validation protocols (IQ, OQ, PQ) and associated reports. 
• Troubleshoot validation-related issues and propose corrective actions to ensure equipment and systems meet operational requirements. 
• Execute testing and document results in accordance with established procedures and protocols. 
• Apply technical writing skills to create and maintain SOPs, protocols, reports, and training materials that meet regulatory and company documentation standards. 
• Monitor change control timelines and escalate potential delays to management. 
• Maintain data integrity and ensure adherence to company and regulatory requirements. 

Required Qualifications: 

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related field; equivalent experience considered. 
• 2 years of experience in the pharmaceutical or biotechnology industry with direct experience in change control, equipment validation, and technical writing. 
• Strong working knowledge of TrackWise Quality Management System (QMS), particularly change control modules. 
• Proven experience writing, executing, and troubleshooting equipment validation protocols. 
• Demonstrated ability to write clear, concise, and compliant technical documents for regulatory and operational purposes. 
• Familiarity with cGMP, FDA, EMA, ICH guidelines, and other applicable regulatory requirements. 
• Excellent organizational skills with the ability to manage multiple priorities simultaneously. 
• Strong written and verbal communication skills, with the ability to interact professionally with all organizational levels. 
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).