Senior Sterile Manufacturing Operator 503B (2nd shift)

The Senior Sterile Manufacturing Operator drives high-impact sterile production ensuring safe, compliant medications reach patients at scale while directly influencing quality, throughput, and regulatory readiness. This role owns execution of aseptic processing, cleanroom operations, and batch integrity within Empower’s fast-scaling 503A/503B environment. Leveraging AI-enabled monitoring, predictive quality insights, and digital batch review, the operator accelerates speed, precision, and deviation reduction. This individual demonstrates rigorous execution, sharp problem-solving, and continuous learning agility. The position integrates advanced sterile techniques with data-driven decision-making to optimize workflows, reduce variability, and enhance compliance. As a key contributor, this role strengthens operational resilience, mentors peers, and ensures consistent adherence to cGMP, USP standards, and Empower’s mission of expanding access to high-quality medications.

Sterile Operations

• Aseptic Execution: Executes complex sterile manufacturing processes within controlled cleanroom environments, applying advanced aseptic techniques and strict adherence to batch records, SOPs, and regulatory standards while leveraging AI-assisted monitoring tools to detect anomalies, optimize interventions, and ensure consistent production quality, throughput efficiency, and contamination control across all stages of sterile compounding and fill-finish operations.

• Process Optimization: Continuously improves sterile workflows by analyzing production data, identifying inefficiencies, and implementing AI-driven recommendations that enhance cycle times, reduce variability, and increase batch success rates while maintaining full compliance with cGMP, USP <797>/<800>, and internal quality systems in a high-throughput, highly regulated manufacturing environment.

• Equipment Mastery: Operates, calibrates, and troubleshoots advanced sterile processing equipment, integrating predictive maintenance insights and AI-enabled diagnostics to minimize downtime, improve equipment reliability, and ensure consistent performance aligned with validated production standards and evolving operational demands.

Quality And Compliance

• Quality Assurance: Ensures uncompromising product quality by executing in-process checks, verifying documentation accuracy, and utilizing AI-supported review systems to identify deviations, strengthen right-first-time outcomes, and uphold strict adherence to regulatory expectations governing sterile pharmaceutical manufacturing environments.

• Regulatory Adherence: Maintains full compliance with FDA regulations, USP standards, and internal policies by rigorously following controlled procedures, supporting audit readiness, and leveraging digital compliance tools to enhance traceability, documentation integrity, and inspection preparedness within a rapidly scaling 503A/503B operation.

• Deviation Management: Identifies, investigates, and resolves deviations using structured problem-solving methodologies augmented by AI-driven root cause analysis, ensuring timely corrective actions, minimizing recurrence risk, and strengthening overall quality systems performance and manufacturing reliability.

Operational Excellence

• Cleanroom Control: Maintains ISO-classified cleanroom environments through disciplined cleaning, disinfection, and environmental monitoring practices, enhanced by AI-enabled trend analysis to proactively identify contamination risks and sustain optimal operating conditions supporting sterile product integrity.

• Production Readiness: Prepares materials, components, and equipment for sterile operations, including autoclaving, part washer, staging, and verification activities, while using data-driven planning tools to ensure seamless production flow, minimize delays, and maximize operational efficiency across shifts.

• Team Mentorship: Guides and mentors junior operators by reinforcing best practices, demonstrating advanced techniques, and promoting a culture of accountability, quality, and continuous improvement, while incorporating digital learning tools and performance insights to accelerate team capability and consistency.

• Advanced knowledge of aseptic processing, cleanroom operations, and sterile manufacturing regulations, including cGMP and USP standards, with the ability to apply precision and consistency in high-stakes production environments.

• Proficiency in interpreting batch records, SOPs, and technical documentation, combined with strong data literacy and ability to leverage AI-enabled systems for monitoring, analysis, and decision support.

• Strong problem-solving, analytical thinking, and deviation investigation capabilities, with experience applying structured methodologies and continuous improvement principles in regulated environments.

• Effective communication and collaboration skills, with the ability to mentor peers, adapt to dynamic production demands, and contribute to a high-performance, quality-driven culture.

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 

• 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.

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.