Pilot Plant Technician

Essential Duties and Responsibilities

• Safely perform manufacturing and Pilot Plant operations in accordance with approved batch records, SOPs, special instructions, and applicable cGMP, safety, and environmental requirements.
• Set up, operate, monitor, and shut down Pilot Plant equipment and systems used for operations such as reactions, filtration, distillation, drying, milling, and material transfer.
• Monitor process conditions and accurately document observations, operating parameters, activities, and results in accordance with applicable procedures and data integrity requirements.
• Clean, inspect, and verify equipment, vessels, and processing areas in accordance with established procedures and cleaning protocols.
• Maintain process flow and appropriately prioritize assigned work with supervisory or technical oversight.
• Identify and communicate process or equipment concerns and assist in troubleshooting processing issues independently or in collaboration with CRD, Engineering, Maintenance, Quality, and other appropriate functions.
• Work independently on Pilot Plant and CRD projects under the technical direction of a CRD Chemist, Engineer, or other designated technical lead and clearly communicate project progress, observations, and results.
• Maintain a clean and orderly work environment in accordance with cGMP, safety, and housekeeping standards.
• Respond appropriately to abnormal plant conditions, process deviations, alarms, spills, and emergency situations in accordance with established procedures and training.
• Properly use required personal protective equipment (PPE) and respiratory protection and maintain the medical qualifications necessary for assigned PPE and respirator use.
• Safely operate powered industrial equipment, including forklifts, when trained and authorized.
• Perform hazardous waste management activities as assigned, including waste determinations, waste profiling, container labeling, inspections, container management, and spill or emergency response activities.
• Maintain appropriate inventories of process-contact disposables, PPE, and other materials required to support Pilot Plant operations.
• Support the purchasing and procurement of equipment, supplies, and materials needed for Pilot Plant activities.
• Assist with the development, review, and maintenance of Pilot Plant SOPs and other controlled documentation.
• Participate in required training and demonstrate continued proficiency in assigned equipment, processes, procedures, and job responsibilities.
• Provide hands-on training and knowledge sharing to peers and other employees as assigned and qualified.
• Collaborate effectively with CRD, Maintenance, Engineering, Quality Control, Quality Assurance, EHS, and other departments supporting Pilot Plant activities.

Good Manufacturing & Documentation Practices

• Perform all documentation in compliance with ALCOA++ principles and site SOPs.
• Adhere to applicable cGMP documents including SOPs, batch records, protocols, change controls, and controlled forms.
• Keep all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department.

Qualifications Required

• High school diploma or GED equivalent.
• Strong reading, mathematical, and comprehension skills sufficient to accurately follow detailed manufacturing instructions, batch records, SOPs, safety documentation, and other controlled procedures.
• Demonstrated mechanical aptitude and ability to learn the operation of manufacturing and process equipment.
• Ability to perform work with a high degree of attention to detail and accurately document activities in accordance with cGMP and data integrity requirements.
• Ability to follow written and verbal instructions and consistently comply with established procedures.
• Ability to successfully complete all required safety, cGMP, equipment, process, and job-specific training.
• Ability to work independently with limited supervision while recognizing when escalation or additional technical support is required.
• Ability to work effectively as part of a team and communicate clearly with peers, supervisors, technical personnel, and cross-functional departments.
• Ability to meet the physical and work environment requirements of the position.
• Ability to become medically qualified to wear required respiratory protection and other PPE.
• Ability to become qualified to operate a forklift and other assigned powered industrial equipment.

Preferred Qualifications

• Advanced education, coursework, or technical training in manufacturing, chemistry, chemical processing, physical sciences, life sciences, or a related field.
• Previous experience in pharmaceutical, chemical, manufacturing, Pilot Plant, or other industrial processing environments.
• Previous experience working in a cGMP-regulated environment.
• Experience operating chemical processing or manufacturing equipment such as reactors, filtration systems, distillation equipment, dryers, mills, pumps, or material transfer systems.
• Experience reading and executing batch records, SOPs, technical instructions, or other controlled manufacturing documentation.
• Experience troubleshooting mechanical or processing issues.
• Experience working collaboratively with technical, engineering, maintenance, quality, or research and development teams.

Physical Requirements

Regularly required to sit, stand, walk, talk, and hear. Frequently required to use hands and fingers to handle or feel objects, reach with hands and arms, and climb, balance, stoop, kneel, crouch, or crawl. May occasionally lift and/or move up to 55 pounds. Work schedule is normally 12 hours covering either days or nights, weekends and holidays to support a 24/7 production operation.

Work Environment

Regular work in a production area of a typical manufacturing facility. The production environment may include moving mechanical parts, fumes or airborne particles, extreme heat, wet or humid conditions, low levels of toxic or caustic chemicals, and outdoor weather conditions.