Sterile Manufacturing Operator Lead (1st shift)

POSITION SUMMARY

The Sterile Manufacturing Operator Lead drives execution across aseptic preparation, mixing, vial filling, documentation, and ISO-classified cGMP operations, protecting product quality, patient access, and production schedules. Owning workflow coordination, workforce deployment, training, escalation, and continuous improvement, this role converts standards into disciplined floor performance. AI serves as a force multiplier by accelerating production analysis, expanding visibility, improving decision quality, strengthening documentation review, and scaling learning without compromising compliance. In Empower's hyper-growth, highly regulated 503A/503B environment, the Lead partners across Manufacturing, Quality, and Technical Operations to sustain readiness, resolve constraints, and raise operating maturity. Success requires strategic thinking, execution rigor, learning agility, sound judgment, and resilience to deliver precise outcomes in a fast-moving sterile manufacturing setting while modeling Empower's values of people, quality, service, and innovation.

RESPONSIBILITIES

Sterile Operations Leadership

• Shift Leadership: Lead daily sterile manufacturing activities across preparation, mixing, aseptic vial filling, cleaning, and disinfection, translating production schedules into clear priorities and coordinated execution. Monitor staffing, material readiness, equipment status, and workflow constraints throughout the shift. Use AI-enabled dashboards and exception alerts to improve visibility, accelerate decisions, and maintain safe, compliant output within Empower's fast-paced 503A/503B manufacturing environment while reinforcing ownership, accountability, performance, and consistent communication across assigned production activities.
• Workforce Coordination: Allocate operators across critical work centers based on qualification, workload, production risk, and schedule demand while supporting breaks, coverage, and rapid response to changing priorities. Coach team members in real time and escalate staffing gaps early. Apply AI-assisted capacity insights to anticipate bottlenecks, balance labor efficiently, and improve throughput without weakening aseptic controls, documentation quality, or employee safety. Support effective handoffs across shifts and departments.
• Floor Ownership: Maintain visible ownership of sterile manufacturing performance by confirming room readiness, line clearance, gowning discipline, material flow, and adherence to standard operating procedures. Identify deviations from expected conditions and initiate timely containment or escalation. Use digital and AI-supported checklists to strengthen consistency, accelerate verification, and identify recurring risk patterns while ensuring production commitments are met with uncompromising attention to quality, service, and patient impact.

Quality and Compliance Execution

• Aseptic Compliance: Execute and reinforce cGMP, ISO-classified, and aseptic processing requirements during compounding and filling activities, including environmental controls, cleaning, disinfection, and contamination prevention practices. Observe behaviors, correct unsafe or noncompliant actions, and involve Quality when required. Leverage AI-guided knowledge tools to retrieve approved procedures efficiently, reinforce training, and improve decision consistency while ensuring human judgment and controlled documentation remain central to each decision and escalation pathway.
• Record Review: Review batch records, logbooks, and manufacturing documentation for completeness, accuracy, traceability, and alignment with approved procedures before routing for formal Quality review. Resolve clear documentation issues promptly and escalate potential non-conformances. Use AI-assisted review capabilities to identify missing fields, inconsistent entries, and recurring error trends, increasing speed and quality while preserving data integrity, operator accountability, and compliance with Empower's regulated 503A/503B requirements.
• Issue Response: Respond to equipment alarms, process interruptions, documentation discrepancies, and potential non-conformances by stabilizing operations, gathering facts, and escalating through established pathways. Support root-cause analysis and implementation of corrective actions within role authority. Apply AI-enabled trend analysis to connect recurring events, prioritize investigation signals, and improve response speed while partnering with Quality, Engineering, and leadership to protect product, people, and production continuity through timely, fact-based actions and documented follow-through.

Performance and Capability Improvement

• Data Improvement: Analyze production, quality, downtime, and labor data to identify trends, recurring losses, and practical opportunities for continuous improvement. Translate findings into actions that strengthen cycle time, schedule adherence, right-first-time performance, and operational reliability. Use AI to accelerate pattern recognition, scenario evaluation, and visual reporting, then validate insights through floor observation and cross-functional review before implementing changes within Empower's high-growth, highly regulated manufacturing environment. Communicate recommendations with supporting evidence and measurable impact.
• Team Development: Train and mentor new hires and developing operators on sterile processes, approved procedures, equipment use, documentation expectations, and disciplined problem-solving. Confirm understanding through observation, feedback, and qualification support. Use AI-enabled learning tools to personalize reinforcement, generate practice scenarios, and identify knowledge gaps at scale while maintaining approved content controls and building a culture of learning agility, collaboration, accountability, safe behaviors, and sustained technical excellence.
• Cross-Functional Partnership: Collaborate with Manufacturing, Quality, Engineering, Warehouse, and Technical Operations to coordinate priorities, resolve constraints, and improve sterile manufacturing readiness. Communicate status, risks, and support needs clearly across shifts and functions. Use AI-supported summaries and action tracking to accelerate alignment, improve follow-through, and strengthen decision quality while contributing floor expertise that enables scalable processes, successful launches, and consistent service to patients and providers.

KNOWLEDGE AND SKILLS

• Working knowledge of sterile compounding, aseptic vial filling, ISO-classified environments, cGMP practices, contamination control, cleaning, disinfection, and controlled manufacturing documentation.
• Ability to lead daily execution, allocate labor, coach peers, manage changing priorities, and communicate risks clearly across Manufacturing, Quality, Engineering, and support teams.
• Proficiency with Microsoft Excel or comparable spreadsheet tools, production metrics, basic math, digital work instructions, and responsible use of AI-enabled analysis and knowledge tools.
• Strong attention to detail, resourcefulness, situational adaptability, accountability, and learning agility, with disciplined judgment in fast-paced, highly regulated manufacturing operations.

EXPERIENCE AND QUALIFICATIONS

• Minimum of one (1) year of compounding experience required.
• High school diploma or equivalent required.
• Demonstrated strong attention to detail, self-motivation, and teamwork skills, with the ability to work effectively in a controlled environment and follow detailed instructions.
• Proficiency in Microsoft Excel or other spreadsheet software and basic math skills required; experience in a lead or mentoring role preferred.