Validation Engineer II

Empower Pharmacy is a visionary healthcare company dedicated to making quality affordable medication accessible to millions of patients nationwide. As the nations most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility were redefining whats possible in personalized medicine and pharmaceutical manufacturing. Were proud to be recognized as one of Houstons 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 weve 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 thats 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. Lets transform healthcare together.

POSITION SUMMARY

Validation Engineer II drives compliance and manufacturing readiness across Empowers 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: 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.