Pharmaceutical Manufacturing Specialist 503B (1st shift)

The Pharmaceutical Manufacturing Specialist supports compliant, high-efficiency sterile production operations that directly impact product quality, throughput, and patient safety. This role owns execution of manufacturing processes, equipment readiness, and batch reliability within Empower’s fast-scaling 503A/503B environment, ensuring strict adherence to cGMP and USP standards while continuously improving yield and cost performance. Leveraging AI as a force multiplier, the specialist enhances process consistency, accelerates deviation resolution, and improves decision-making through data-driven insights. This individual demonstrates strong execution rigor, problem-solving acuity, and learning agility while contributing to scalable, inspection-ready operations aligned with Empower’s hyper-growth trajectory and regulatory excellence standards. This role is critical to sustaining operational resilience, advancing innovation, and delivering consistent, high-quality pharmaceutical products.

Manufacturing Execution

• Batch Execution: Execute sterile manufacturing processes in strict adherence to SOPs, cGMP, and USP standards, ensuring consistent batch quality and throughput while leveraging AI-enabled monitoring systems to detect variability, optimize cycle times, and enhance real-time decision-making in a high-growth, highly regulated 503A/503B production environment.

• Process Discipline: Maintain rigorous aseptic technique and cleanroom compliance by following validated procedures and utilizing AI-assisted checklists and environmental monitoring tools to minimize contamination risk, ensure reproducibility, and sustain inspection-ready operations aligned with regulatory expectations.

• Throughput Optimization: Support production targets by identifying inefficiencies in workflows, applying AI-driven insights to streamline operations, reduce downtime, and improve manufacturing velocity while maintaining uncompromising quality and compliance standards.

Quality And Compliance

• Deviation Resolution: Identify, document, and support investigation of deviations and non-conformances using AI-supported root cause analysis tools to accelerate issue resolution, strengthen CAPA effectiveness, and enhance overall quality system performance in a regulated manufacturing environment.

• Standards Compliance: Ensure all activities consistently meet cGMP, USP 797/800, and internal quality requirements by leveraging digital systems and AI validation tools to maintain accuracy, traceability, and continuous audit readiness.

• Audit Readiness: Maintain complete, accurate documentation and proactively identify compliance risks, utilizing AI-driven audit preparation tools and data validation systems to support successful regulatory inspections and minimize operational disruptions.

Process Improvement And Support

• Continuous Improvement: Apply lean manufacturing principles and AI-enabled analytics to identify process gaps, improve yield, reduce waste, and enhance operational reliability, contributing to scalable, high-performance manufacturing aligned with Empower’s growth strategy.

• Technology Adoption: Support implementation and optimization of new equipment and manufacturing technologies, using AI-assisted validation and performance tracking to ensure seamless integration and sustained operational efficiency.

• Operational Coordination: Collaborate cross-functionally with quality, engineering, and operations teams while leveraging AI-driven workflow and communication tools to resolve issues, improve processes, and ensure alignment across manufacturing activities.

• Strong expertise in cGMP, USP 797/800, aseptic processing, and cleanroom operations, with ability to apply AI-enabled tools to enhance compliance, documentation accuracy, and operational consistency.

• Proficiency in manufacturing systems, data analysis, and digital tools, leveraging AI insights to improve process performance, deviation management, and production decision-making.

• Solid understanding of lean manufacturing principles, continuous improvement methodologies, and process optimization within regulated pharmaceutical or high-compliance production environments.

• Effective collaboration, communication, and problem-solving skills with demonstrated ability to operate in fast-paced, high-growth environments while maintaining precision, accountability, and quality focus.

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 with cleanroom manufacturing or sterile compounding required.

• High school diploma or equivalent required; degree in a life science or engineering highly preferred.

• Exhibits strong interpersonal skills with adaptability, collaboration, and effective communication in a fast-paced environment.

• Demonstrates expertise in cGMP, aseptic processing, USP 797/800 compliance, and proficiency in Microsoft Office, meeting certification and cleanroom requirements.

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.