Manufacturing Operator

Job Description Job Title: Manufacturing Operator Job Description The Manufacturing Operator works under direct supervision to operate pharmaceutical manufacturing equipment in a cGMP environment, producing clinical supplies and supporting development experiments. This role combines hands‑on equipment operation, meticulous documentation, and collaboration with quality, maintenance, and development teams in a fast‑growing contract manufacturing setting. Responsibilities Train on and consistently follow all applicable policies and procedures, including regulatory requirements, safety guidelines, standard operating procedures (SOPs), work instructions, and related documentation. Perform pharmaceutical manufacturing activities in a GMP or other regulated manufacturing environment while maintaining strict compliance with quality and safety standards. Execute batch record activities and maintain Good Documentation Practices (GDP), ensuring all manufacturing data, entries, and corrections are accurate, complete, and legible. Set up manufacturing lines, perform changeovers, and operate production and packaging equipment according to established procedures. Carry out room and equipment setup, operation, and cleaning for pharmaceutical production, ensuring areas and equipment meet cleanliness and readiness requirements. Use appropriate personal protective equipment (PPE) and engineering controls to perform all tasks safely and in accordance with safety policies. Conduct in-process inspections and sampling to verify product quality and process performance, documenting results as required. Use the designated IT platform and computer systems to enter data, complete electronic records, and support manufacturing and quality processes. Perform developmental manufacturing experiments under the direction of a formulation specialist or process engineer, following experimental protocols and documenting outcomes. Support investigational and quality systems activities, including assisting with deviations, corrective actions, and continuous improvement initiatives. Assist maintenance personnel with preventative maintenance activities, basic troubleshooting, and minor repairs of manufacturing equipment as needed. Participate actively in continuous improvement activities by suggesting process enhancements, efficiency gains, and quality improvements. Remain current with professional and industry trends, incorporating new knowledge into daily work where appropriate. Make positive contributions by offering suggestions for improvement and actively learning new skills, procedures, and processes. Carry out duties in full compliance with all applicable federal and state regulations, as well as company and site policies and procedures. Remain available for additional duties as required to support production schedules and operational needs. Be available for overtime as needed to meet production and project timelines. Essential Skills Associates Degree in a scientific discipline, engineering, or a related field. At least 2 years of experience in GMP pharmaceutical manufacturing, research and development (R&D), or pharmaceutical equipment manufacturing. 2+ years of experience with batch record review, QA operations, and line clearance in a pharmaceutical or CDMO GMP environment. Hands‑on experience as a manufacturing operator or packaging technician in a regulated or GMP manufacturing setting. Demonstrated experience working within QA and compliance requirements in a pharmaceutical or CDMO production environment. Strong knowledge of current Good Manufacturing Practices (cGMP) and their application to daily manufacturing activities. Ability to read and interpret standard operating procedures, manuals, batch records, work instructions, and specifications. Legible handwriting and the ability to complete detailed written documentation accurately and consistently. Clear written and oral communication skills for effective interaction with cross‑functional teams and accurate documentation. Proficiency with basic arithmetic, including addition, subtraction, fractions, percentages, ratios, and proportions, and the ability to apply these concepts to practical manufacturing tasks. Ability to identify simple and moderate problems related to job functions and elevate or resolve them appropriately. Demonstrated deductive reasoning skills to apply general rules to specific problems and produce logical solutions. Demonstrated inductive reasoning skills to combine pieces of information and identify patterns, trends, or relationships. Ability to perform repetitive tasks while ma #J-18808-Ljbffr Actalent