Sterile Manufacturing Operator (2nd shift
Listed on 2026-08-21
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Manufacturing / Production
Pharmaceutical Manufacturing, Production QC/QA, Validation Engineer, Regulatory Compliance Specialist
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 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 SUMMARYThe 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.
RESPONSIBILITIESAseptic 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.
- 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.
- Throughput Optimization:
Execute production schedules efficiently while meeting output…
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