Senior Sterile Manufacturing Operator 503B

Socket.dev; Houston (TX); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Job summary

Empower Pharmacy, a leading sterile manufacturing and compounding facility in Houston, seeks a Senior Sterile Manufacturing Operator to execute aseptic processes within a highly regulated 503A/503B environment. You will own cleanroom workflows, equipment operation, component prep, and strict documentation to ensure patient safety and quality.

You will contribute to continuous improvement, mentor developing operators, and help maintain production readiness in a fast-moving setting enhanced by

Qualifications

• Advanced knowledge of aseptic technique and sterile manufacturing workflows.
• Working knowledge of cleanroom practices and environmental controls.
• Disciplined execution within controlled pharmaceutical production environments.
• Strong documentation and compliance focus in regulated settings.

Responsibilities

• Execute advanced aseptic manufacturing activities within cleanroom environments.
• Operate sterile processing equipment and perform required calculations and checks.
• Prepare components, operate autoclaves, and perform bubble point testing to maintain readiness.

Skills

Aseptic technique

Sterile manufacturing

Cleanroom practices

Environmental controls

Education

High School Diploma or equivalent

Gown qualification for cleanroom entry

Sterile operations training

Job description

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 OVERVIEW:

The Senior Sterile Manufacturing Operator executes advanced aseptic manufacturing activities that ensure safe, accurate, and reliable production of sterile medications in Empower’s hyper-growth, highly regulated 503A/503B environment. This role owns disciplined execution of cleanroom workflows, equipment operation, component preparation, documentation, and environmental controls while consistently following approved procedures and regulatory requirements.

The operator applies strong judgment to identify issues, protect product quality, and maintain production readiness without compromising compliance or patient safety. As an experienced individual contributor, this position also reinforces proper technique, supports developing operators, and contributes to continuous improvement efforts that strengthen throughput, consistency, and operational control. Success requires learning agility, precision, accountability, and the ability to perform effectively in an AI-enabled organization where technology supports faster, higher-quality decisions and more efficient execution across sterile manufacturing operations daily.

ESSENTIAL JOB FUNCTIONS:

Sterile Production

• Aseptic Operations: Execute advanced sterile manufacturing activities using qualified aseptic techniques, approved batch records, procedures, and established production controls within cleanroom environments.
• Equipment Operation: Operate sterile processing equipment accurately and consistently, completing required calculations, checks, and production steps to support safe, compliant batch execution.
• Component Preparation: Prepare components and materials, operate autoclaves, and perform bubble point testing to maintain production readiness and support reliable sterile processing.

Quality And Compliance

• Procedure Adherence: Follow applicable requirements, including 21 CFR Parts 210 and 211 and USP Chapters 797 and 800, during assigned manufacturing activities.
• Cleanroom Control: Perform required cleaning, disinfection, and sterilization of components, equipment, and work areas in accordance with established cleanroom and ISO controls.
• Documentation Accuracy: Complete production records accurately and contemporaneously, verifying calculations and required entries to support traceability, quality review, and compliant batch documentation.

Operational Excellence

• Issue Resolution: Identify production issues, apply sound judgment, and elevate concerns appropriately to protect quality, safety, workflow continuity, and established manufacturing requirements.
• Process Improvement: Contribute practical improvement ideas that strengthen safety, throughput, consistency, inventory coordination, and workflow efficiency without compromising established quality or regulatory controls.
• Operator Support: Reinforce proper sterile processing techniques with developing operators by demonstrating approved practices, answering procedural questions, and promoting consistent execution across the team.

KNOWLEDGE AND SKILLS

• Advanced knowledge of aseptic technique, sterile manufacturing workflows, cleanroom practices, environmental controls, and disciplined execution within controlled pharmaceutical production environments.
• Working knowledge of 21 CFR Parts 210 and 211, USP Chapters 797 and 800, and applicable ISO cleanroom requirements.
• Strong capability in sterile equipment operation, component preparation, autoclave use, bubble point testing, calculations, and accurate production documentation.
• Proven judgment, problem-solving, communication, and continuous improvement skills for resolving production issues while protecting quality, safety, compliance, and operational consistency.

EXPERIENCE AND QUALIFICATIONS:

• Minimum of 3 years of experience in sterile manufacturing, aseptic processing, or cleanroom production within a regulated pharmaceutical or scientific environment.
• High School Diploma or equivalent required; relevant technical coursework strongly preferred.
• Minimum of 3 years of experience performing work governed by controlled procedures, including the ability to achieve and maintain cleanroom gowning qualification.
• Minimum of 3 years of experience operating sterile manufacturing equipment, performing accurate documentation, and solving operational challenges within a team-driven production environment.
• Gown Qualification for cleanroom entry; sterile operations training; additional aseptic processing or cleanroom certifications strongly preferred.

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.