Empower Pharmacy

Empower Pharmacy

Sterile Manufacturing Operator

Houston, TX

Sponsorship not specifiedDetected 13 days ago
HRISGMPFDA RegulatoryLeadershipCollaborationProblem SolvingAdaptability

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Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • 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.

Responsibilities

  • 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.
  • 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, escalate, 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.
  • 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.
  • Ability to follow SOPs with precision and maintain strong documentation accuracy.

Requirements

  • While performing the responsibilities of the job, the employee is required to talk and hear.
  • 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.
  • Demonstrated ability to follow detailed procedures with a high degree of accuracy.
  • Comfort working in cleanroom environments and complying with aseptic gowning requirements.
  • Conduct cleaning and sanitization of equipment and production rooms, including equipment setup, while maintaining required contamination-control practices.
  • Support internal and external audits through disciplined execution and a strong understanding of regulatory expectations and compliance requirements.
  • High school diploma or equivalent required; technical training preferred.

Nice to have

  • High school diploma or equivalent required
  • technical training preferred.
  • Experience in sterile manufacturing, compounding, or another regulated production environment preferred.

Skills

  • Knowledge of aseptic processing, cleanroom behavior, and contamination-control practices.
  • Familiarity with cGMP requirements, FDA regulations, and sterile manufacturing environments.

Benefits

  • 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.
  • https://careers.empowerpharmacy.com/benefits/
  • Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide.
  • We're proud to be recognized as one of Houston's fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc.
  • 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.
  • It means becoming part of a mission-driven organization that's transforming healthcare at scale.
  • Let's transform healthcare together.

Company info

  • 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.
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This listing is sourced directly from Empower Pharmacy's careers page and normalized into a canonical job model.