Pilot Plant Technician

About the company

Curia

Pharmaceuticals · 1,001 to 5,000 employees

What you'll do

• 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.
• Report to work fit for duty and adhere to assigned work schedules.
• Perform other duties and responsibilities as assigned.
• 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.
• 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.
• 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.
• 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.
• Visual requirements include close vision, distance vision, peripheral vision, color vision, depth perception, and the ability to adjust focus.
• Work schedule is normally 12 hours covering either days or nights, weekends and holidays to support a 24/7 production operation. Must be able to work overtime as required and report fit for duty on scheduled shifts.
• 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.
• Noise level in the work environment is typically moderate.

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