Fractionation Production Specialist

Role Summary

The role is responsible for overseeing Fractionation processes by utilizing resources in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. You are expected to fully participate in both departmental projects and any quality working teams which may be applicable including problem solving in other functional areas as needed. You will fully understands the regulations and may make recommendations according to their interpretations. You are responsible for the successful transfer of new processes/methodologies into the manufacturing area. You will apply corrective and preventive actions to complex situations and mentor others in quality issue prevention. You will assist in managing quality assurance efforts and provide recommendations for improvements. You will conduct independent root cause analysis of process related issues and recommend improvements.

Responsibilities

• Provide floor-level technical support for manufacturing equipment (setup, changeover, operation support, and troubleshooting).
• Lead and deploy the best practices in the manufacturing organization.
• Diagnose equipment and process upsets using structured problem-solving and implement corrective/preventive actions.
• Partner with Maintenance/Engineering to plan and execute preventive maintenance, critical spares strategy, and reliability improvements.
• Support installation and commissioning activities for new or modified equipment, ensuring readiness for production use.
• Implement and maintain quality control systems to ensure high-quality production.
• Lead continuous improvement initiatives to streamline production processes and reduce waste.
• Monitor and improve process performance (cycle time, yield, scrap/rework, OEE, stability).
• Develop/update process parameters, work instructions, and settings aligned to product and quality requirements.
• Manage, mentor and train a team of production workers, providing direction, support on equipment operation, process parameters, and troubleshooting best practices.
• Prepare production reports and maintain accurate records of production activities.
• Support implementation of change controls, projects and new methodologies to improve production processes.
• Support document revisions, quality investigations and CAPA process.
• Effectively works and communicates with engineers, technicians, managers, and other departments to ensure smooth and seamless production processes.

Qualifications

• High school diploma or equivalent required, Bachelor’s degree in scientific discipline or equivalent certification preferred.
• 4+ years of manufacturing, warehouse, and/or technical office experience, supporting equipment, Maintenance and/or process engineering.
• 2+ years of team leadership or demonstrated experience leading cross-functional teams, preferably including fractionation operations.
• Demonstrated ability to troubleshoot equipment/process issues using data and structured problem-solving.
• Working knowledge of manufacturing KPIs (e.g., OEE, yield, scrap, downtime) and basic statistical tools.
• Ability to work on the production floor and support off-shift/escalation as needed.
• Strong problem-solving and analytical skills are required.
• Strong leadership skills are required.
• Possess knowledge of core manufacturing principles and support systems (Fractionation separation equipment / support systems (WFI / RO / clean steam / compressed gases / HVAC) and facility design.
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
• Self-driven individual that requires minimal supervision.
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
• Prefer experience in Automation Control Systems, EBM (Electronic batch Record), PI Historian.
• Continuous improvement mindset (Utilize continuous improvement tools to drive positive change in department processes).
• Prefer knowledge of Lean Six-Sigma methodology.

Skills

• Problem-solving and analytical thinking
• Data-driven decision making
• Cross-functional collaboration and communication
• Technical aptitude with manufacturing equipment and processes
• Basic statistical tools and KPI interpretation
• MS Office proficiency
• Continuous improvement mindset

Education

• High school diploma or equivalent; Bachelor’s degree in scientific discipline or equivalent certification preferred.

Additional Requirements

• Work in a controlled environment requiring special gowning and protective clothing; possible hearing protection in loud areas.
• Must be able to lift up to 50 lbs; frequent lifting, carrying, pushing, pulling, or moving objects.
• Work on the production floor and in production areas for extended periods.
• Travel for this position will include less than 5% locally, usually for training purposes.
• Work off hours as required during critical operations, deviations, or shutdown/startup activities.
• May be required to enter controlled environments requiring special gowning.