Sterile Manufacturing Operator

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: The Sterile Manufacturing Operator executes aseptic production processes critical to delivering safe, high-quality compounded medications at scale within Empower's regulated 503A/503B environment. This role owns precise batch execution, documentation integrity, and contamination control while leveraging AI-enabled systems to enhance accuracy, throughput, and deviation detection. Operating with rigorous standards, the operator supports production reliability and compliance while demonstrating P80-P90 talent traits, including disciplined execution, strong problem-solving, learning agility, and a continuous improvement mindset aligned with hyper-growth operational demands and evolving regulatory expectations. Responsibilities: Aseptic Operations Process Execution and Batch Documentation: Perform sterile compounding and/or filling using validated aseptic techniques in compliance with SOPs and cGMP requirements. Maintain accurate batch records and electronic documentation, leveraging AI-enabled systems to support traceability, documentation quality, and operational efficiency. Gowning and Process Recovery: Perform aseptic gowning in accordance with established procedures to support sterile processing activities. Conduct cleaning and sanitization of equipment and production rooms, including equipment setup, while maintaining required contamination-control practices. Equipment Handling: Operate, clean, and maintain sterile manufacturing equipment, including isolators and cleanroom systems, ensuring readiness, calibration compliance, and consistent performance aligned with validated production processes and regulatory standards. Quality and Compliance Deviation Reporting: Identify, elevate, and document deviations, non-conformances, and quality events. Support root-cause investigations and corrective actions while maintaining strict adherence to FDA, USP, and internal quality requirements. Environmental Monitoring: Support cleanroom monitoring activities, including sampling and documentation, to maintain compliance with environmental standards. Use data insights and AI-enabled trend analysis tools to help identify emerging risks and support proactive response. Audit Readiness: Maintain inspection-ready work areas, documentation, and practices at all times. Support internal and external audits through disciplined execution and a strong understanding of regulatory expectations and compliance requirements. Operational Excellence Throughput Optimization: Execute production schedules efficiently while meeting output targets without compromising quality. Use AI-driven insights to support improved cycle times, reduced waste, and enhanced manufacturing performance. Continuous Improvement: Identify process inefficiencies and recommend improvements, contributing to lean initiatives and leveraging technology to streamline workflows, increase reliability, and support scalable manufacturing operations. Cross-Functional Collaboration: Partner with Quality, Maintenance, and Production teams to resolve issues, improve processes, and support seamless operations across functions within a fast-paced, highly regulated manufacturing environment. Knowledge and Skills: Knowledge of aseptic processing, cleanroom behavior, and contamination-control practices. Ability to follow SOPs with precision and maintain strong documentation accuracy. Familiarity with cGMP requirements, FDA regulations, and sterile manufacturing environments. Basic data literacy with the ability to use AI-enabled tools to support operational insights and decision-making. Experience and Qualifications: High school diploma or equivalent required; technical training preferred. Experience in sterile manufacturing, compounding, or another regulated production environment preferred. Demonstrated ability to follow detailed procedures with a high degree of accuracy. Comfort working in cleanroom environments and complying with aseptic gowning requirements. 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: 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. #J-18808-Ljbffr Empower Pharmacy