Validation Engineer

Validation Engineer

This validation engineer is tasked with supporting laboratory instrumentation and computerized systems within a GMP-regulated environment, with an emphasis on data integrity. This position serves as a subject matter expert and system administrator for instruments and systems used in QC testing, analytical, and microbiological analysis instruments. The engineer provides technical oversight, manages qualification activities, and ensures regulatory compliance and data reliability throughout system lifecycles.

Responsibilities

• Serve as a subject matter expert and system administrator for QC laboratory instruments and computerized systems, including analytical and microbiological equipment.
• Ensure all computerized systems are implemented and maintained in compliance with data integrity principles, GMP regulations, and internal policies.
• Manage qualification, validation, and periodic review activities for laboratory instruments and computerized systems.
• Troubleshoot instrumentation/system issues and coordinate resolution with internal teams or external vendors.
• Author and review documentation including SOPs, user requirements, system specifications, and validation protocols.
• Collaborate with IT, validation, and QC personnel on change controls, deviations, and investigations.
• Act as a key laboratory resource for audit/inspection readiness activities; presenting data integrity and system management processes during regulatory inspections.
• Lead and participate in risk assessments and continuous improvement initiatives to enhance system reliability and compliance.
• Provide training to QC staff on the operation and administration of laboratory computerized systems.
• Maintain current knowledge of regulatory expectations and best practices related to data integrity and computerized system validation.
• Foster effective working relationships with internal and external stakeholders.
• Ensure all laboratory activities are conducted in full compliance with cGMP and applicable quality system requirements.
• Implement and maintain robust data backup and disaster recovery strategies for critical laboratory systems.
• Contribute to regulatory inspection readiness through proactive compliance and documentation practices.
• Ensure continued GxP compliance of QC laboratory computer systems and software.
• Perform additional duties and projects as assigned by management.

Essential Skills

• Engineering, quality assurance, quality system, validation, systems engineering.
• Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance, audit, lab equipment, IQ, OQ, PQ.
• Audit and FDA experience.

Additional Skills & Qualifications

• Education in Engineering, Life Sciences, Computer Science, or a related field is required. Master's degree preferred.

The pay range for this position is $100000.00 - $130000.00/yr.

The company operates at the intersection of regenerative medicine and biotechnology, offering opportunities to work on innovative cell therapy technologies. This can be especially appealing to professionals in R&D, clinical development, and manufacturing. Employees have the chance to be part of a company that is changing the standard of care for CKD patients, which can be deeply fulfilling for those motivated by patient outcomes.

This is a fully onsite position in Winston Salem, NC.

This position is anticipated to close on Oct 24, 2025.