Staffana · 11 hours ago
Validation Engineer (Lab Equipment)
Franklin, TN
Contract
Onsite
Senior Level, Lead/Staff
$45/hr - $52/hr
4+ years expStaffana is a company focused on quality assurance in lab environments, and they are seeking a Quality Assurance Staff Engineer. This role will support lab-based quality processes by developing and implementing process controls, testing, inspection, and continuous improvement initiatives to ensure products meet quality, safety, and regulatory standards.
Outsourcing/Offshoring
Responsibilities
Develop and implement quality methods, procedures, and process controls to ensure products are free from defects and perform as designed
Support lab-based processes, including testing, inspection, and control activities, to maintain quality levels and minimize defect and failure rates
Design, install, qualify, and support laboratory testing equipment (e.g., desktop lab equipment, cell counters), including IQ/OQ/PQ and validation activities
Perform product testing and data analysis, review defect trends, and recommend corrective and preventive actions (CAPA)
Collaborate daily with QE and QS partners to support quality operations and continuous process improvement initiatives
Implement change management and process improvement efforts, including stability processes for internal drug products, quarantine workflows, and lab management processes
Develop, update, and remediate QMS documentation, including SOPs, procedures, forms, and guidance documents to support best-in-class quality standards
Conduct internal audits of lab and quality processes to ensure compliance with established procedures and regulatory expectations
Interface with suppliers as needed to support validation and IQ documentation, contributing to supplier quality improvement efforts
Support quality activities related to internal drug product (PDGF) manufacturing and testing operations
Qualification
Required
Bachelor's degree required (Engineering preferred)
4–5+ years of experience in Quality Assurance, Quality Engineering, or related roles within lab-based, regulated environments
Hands-on experience with laboratory testing, process controls, equipment qualification, and quality systems
Strong working knowledge of process improvement, root cause analysis, CAPA, and change management
Experience developing and maintaining QMS documentation and supporting audit readiness
Ability to apply professional and technical knowledge to resolve quality issues as they arise
Company
Staffana
Staffana helps growing firms reach their full potential by allowing them to develop highly trained global teams in days rather than months.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase