Senior Engineer, Corporate Quality Assurance - Validation

This is a hybrid role located in Sugar Land, Texas.

About the role

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.

Responsibilities

• Ensures analytical methods are validated and transferred in compliance with ICH (e.g., Q2), USP, and regulatory expectations
• Oversees and enforces data integrity controls in accordance with FDA requirements and ALCOA+ principles
• Provides QA oversight of laboratory and validation activities to ensure compliance with internal procedures and regulatory standards
• Reviews 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 documented
• Authors and executes validation deliverables as needed to support business priorities
• Serves as QA representative during audits and regulatory inspections related to validation and laboratory systems
• Partners cross-functionally (QC, Validation, IT, Manufacturing) to ensure validation lifecycle compliance
• Assesses validation impact within change control processes
• Supports investigations involving validation deviations or data integrity issues
• Drives continuous improvement of validation and quality systems
• Provides technical leadership and mentors junior staff and cross-functional teams

Requirements

• 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 industry
• Working knowledge of USP and ICH regulatory requirements
• Experience reviewing and approving validation documentation
• Familiarity with GMP (Good Manufacturing Practices) environments
• Strong background in laboratory validation
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Skills

• Strong attention to detail and critical thinking skills
• Independent judgment and decision-making
• Strong written and verbal communication skills
• Ability to influence cross-functional teams without direct authority
• Risk-based thinking and problem-solving
• High level of integrity and accountability

Qualifications

• Experience in Validation roles rather than execution-focused Quality Assurance roles
• Exposure 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

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental, and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice

About 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.