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, and compliance assessments through maintenance of validation documentation and technical records. Leverages AI-assisted reporting and document management systems to strengthen readiness and documentation accuracy.
Operational Excellence
- Equipment Operations: Supports qualification and operation of sterilization, cleaning, lyophilization, and manufacturing systems supporting production readiness and validation requirements. Utilizes AI-enabled monitoring tools to improve system reliability and process performance.
- Technical Collaboration: Partners with Manufacturing, Engineering, Quality, Regulatory Affairs, Research and Development, and contractors supporting CQV activities. Applies AI-enabled collaboration platforms and analytics to improve communication, issue resolution, and project success.
- Continuous Improvement: Identifies opportunities to improve validation methodologies, documentation processes, and operational efficiency. Utilizes AI-powered analytics and automation technologies to strengthen validation effectiveness, compliance execution, and business performance.
Knowledge and Skills:
- Strong expertise in validation lifecycle management, CQV activities, equipment qualification, process validation, computer system validation, and regulatory compliance.
- Proficiency using AI-enabled analytics tools, validation software, quality management systems, Microsoft Office applications, and digital documentation platforms.
- Advanced knowledge of cGMP regulations, GAMP guidance, 21 CFR Part 11 requirements, sterilization validation, cleaning validation, and risk-based validation methodologies.
- Strong analytical, project management, communication, and problem-solving skills with the ability to manage multiple priorities and maintain compliance standards.
Experience and Qualifications:
- Bachelor of Science degree in Engineering, Pharmaceutical Sciences, Biology, Chemistry, or related scientific discipline required.
- Minimum 3 years of validation experience within pharmaceutical, biotechnology, healthcare, or regulated manufacturing environments preferred.
- Experience with equipment qualification, process validation, computer system validation, change control, CAPA management, and regulatory compliance activities strongly preferred.
- Experience supporting sterile manufacturing, cleaning validation, sterilization validation, and CQV projects preferred.
- Certified Quality Engineer (CQE) or equivalent certification preferred.
- Demonstrated ability to execute with precision, adapt quickly to operational demands, and contribute effectively within high-performance environments.
Key Competencies:
- Customer Focus: Builds trust through customer-centric solutions.
- Strategic AI: Guides responsible AI adoption and adaptation.
- Optimizes Work Processes: Drives efficiency with continuous improvement.
- Collaborates: Partners effectively to achieve shared goals.
- Resourcefulness: Secures and deploys resources efficiently.
- Manages Complexity: Simplifies and solves complex challenges.
- Ensures Accountability: Delivers on commitments with integrity.
- Situational Adaptability: Adjusts approach to shifting conditions.
- Communicates Effectively: Tailors messages to diverse audiences.
Values:
- People: Empowering people defines who we are.
- Quality: Excellence in every product, every time.
- Service: Serving others is our highest purpose.
- Innovation: Advancing care through technology and discovery.
Employee Benefits, Health, and Wellness:
We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/
Physical Requirements:
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.