Senior Engineer, Corporate Quality Assurance - Validation

The Senior Engineer, Corporate Quality Assurance – Validation is an individual contributor within the Corporate Quality Assurance organization responsible for ensuring company-wide validation and qualification activities comply with cGMP (21 CFR Parts 210/211), 21 CFR Part 11, and applicable USP and ICH guidelines. This role supports validation of equipment, processes, computerized systems, and analytical methods, including instrument qualification, method validation, and method transfer, while driving risk-based, efficient validation lifecycle practices in an FDA-regulated environment.The position requires strong expertise in analytical validation and data integrity, with a focus on compliance, quality, and continuous improvement. The role partners across Quva sites to standardize and sustain validation methodologies, ensuring consistency and regulatory alignment. Working cross-functionally with IT, Quality, Operations, Engineering, Facilities, and Pharmacy Services, the Senior Engineer ensures validation activities are scientifically sound, compliant, and effectively executed to support both projects and routine operations.The ideal candidate has extensive experience in pharmaceutical manufacturing, deep knowledge of analytical validation, and a strong understanding of global regulatory expectations, contributing to Quva’s mission of expanding access to high-quality, affordable medications.Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.This is a hybrid role, located in Sugar Land, Texas. What the Senior Engineer, Corporate Quality Assurance - Validation Does Each Day:Ensures analytical methods are validated and transferred in compliance with ICH (e.g., Q2), USP, and regulatory expectationsOversees and enforces data integrity controls in accordance with FDA requirements and ALCOA+ principlesProvides QA oversight of laboratory and validation activities to ensure compliance with internal procedures and regulatory standardsReviews and approves validation deliverables (e.g., IQ/OQ/PQ/PV protocols, reports, risk assessments, lifecycle documents, change controls, and Part 11 assessments), ensuring activities are appropriately designed, executed, and documentedAuthors and executes validation deliverables as needed to support business prioritiesServes as QA representative during audits and regulatory inspections related to validation and laboratory systemsPartners cross-functionally (QC, Validation, IT, Manufacturing) to ensure validation lifecycle complianceAssesses validation impact within change control processesSupports investigations involving validation deviations or data integrity issuesDrives continuous improvement of validation and quality systemsProvides technical leadership and mentor junior staff and cross-functional teamsOur Most Successful Senior Engineer, Corporate QA - Validation:Strong attention to detail and critical thinking skillsIndependent judgment and decision-makingStrong written and verbal communication skillsAbility to influence cross-functional teams without direct authorityRisk-based thinking and problem-solvingHigh level of integrity and accountabilityMinimum Requirements for this Role:Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related field (advanced degree preferred)5–8+ years of experience in Quality Assurance, Validation, or related roles within the pharmaceutical or biotech industryWorking knowledge of USP and ICH regulatory requirementsExperience reviewing and approving validation documentationFamiliarity with GMP (Good Manufacturing Practices) environmentsStrong background in laboratory validation, including:18+ years of ageAble to successfully complete a drug and background checkMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visasAny of the Following Will Give You an Edge: Experience in Validation roles rather than execution-focused Quality Assurance rolesExposure to regulatory inspections (e.g., FDA audits) Knowledge of data integrity principles (e.g., ALCOA+) Experience with electronic systems used in laboratory and validation environments (e.g., LIMS) Benefits of Working at Quva:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match17 paid days off plus 8 paid holidays per yearOccasional weekend and overtime opportunities with advance noticeNational, industry-leading high growth company with future career advancement opportunitiesAbout Quva:Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”California Consumer Privacy Act (CCPA) Notice for Applicants and EmployeesJob SummaryRequisition Number: SENIO006004Job Category: 8000-QualitySchedule: Full-Time