Validation Engineer II

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation’s most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we’re redefining what’s possible in personalized medicine and pharmaceutical manufacturing. We’re proud to be recognized as one of Houston’s fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc.

5000 List for 2025. Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we’ve created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care.

From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that’s transforming healthcare at scale.

We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you.

Let’s transform healthcare together. POSITION SUMMARY Validation Engineer II drives compliance and manufacturing readiness across Empower’s 503A and 503B operations through validation activities supporting sterile and non-sterile manufacturing. This role manages equipment qualification, process validation, computer system validation, and compliance documentation ensuring regulatory readiness and operational scalability.

Leveraging AI-enabled analytics, automated workflows, predictive monitoring, and digital quality systems, the position improves decision-making, validation accuracy, and execution efficiency. Success requires strategic thinking, execution rigor, learning agility, and disciplined problem solving within a hyper-growth, highly regulated environment. Talent demonstrates accountability, technical expertise, collaboration, and continuous improvement supporting compliance excellence, manufacturing continuity, and business performance.

RESPONSIBILITIES

Validation Execution Lifecycle Management : Manages validation activities for equipment, facilities, processes, utilities, and computer systems supporting compliant manufacturing operations. Utilizes AI-enabled analytics and workflow automation to improve execution consistency, issue resolution, and validation performance. Protocol Development : Develops, executes, reviews, and maintains validation protocols and reports including IQ, OQ, PQ, FAT, SAT, and process validation documentation.

Applies AI-assisted tools to improve quality, traceability, and execution efficiency. Project Coordination: Oversees multiple validation projects ensuring timelines, budgets, and quality expectations are achieved. Leverages AI-powered project tracking and reporting tools to improve prioritization, visibility, and project execution.

Compliance And Quality Compliance Support: Executes validation activities in accordance with FDA regulations, cGMP

Requirements

, GAMP guidance, and 21 CFR Part 11 expectations. Utilizes AI-enabled compliance monitoring tools to improve oversight, consistency, and inspection readiness. Change Management: Supports change control, CAPA implementation, deviation investigations, and quality events impacting validated systems and processes.

Applies AI-powered trend analysis and risk assessment tools to improve root cause identification and corrective actions. Audit Readiness: Supports audits, inspections, an