Manufacturing Lead Technician

Oversee coordination and operations of the production schedule, shift, and personnel Set up and operate equipment in a biologics processing environment for plasma-derived pharmaceuticals Follow procedures and practices according to FDA regulations Complete documentation according to FDA regulations Follow departmental corporate safety policies Clean facilities and equipment Perform basic process analyses, including pH, refractive index, turbidity, and conductivity measurements Operate ultrafiltration units, chromatography columns, CIP systems, SIP systems, and centrifuges Use touchscreen Operator Interface Terminals Train entry-level personnel Perform complex and advanced job tasks Assist management with coordinating and scheduling day-to-day department operations Serve in a leadership role in the absence of direct supervision Perform other assigned duties Requirements High school diploma or GED required Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines Ability to work independently with minimum supervision Must be proactive, results oriented, and have strong attention to detail Self-starter with strong work ethic and the ability to exercise good judgment Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment Must be able to read, write, and speak English Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint) Must be flexible with working hours/shifts for 24-hour, 7-day plant operation Ability to work in a clean-room manufacturing environment with exposure to biological fluids, chemicals, electrical equipment, moving machinery, noise, extreme cold, and confined spaces Ability to operate forklifts, tractors, and power equipment Ability to stand and walk for 4–6 hours per day, bend and twist for 4–6 hours per day, and perform frequent hand and foot movements Ability to frequently lift and carry 15–44 lbs and 45 lbs, with a maximum lift of 50 lbs Hearing acuity, color perception/discrimination, depth perception, and specified correctable vision required Ability to communicate and understand spoken and written information Core Competencies Demonstrates expertise in overseeing production operations in a biologics processing environment, with a strong focus on compliance with FDA regulations and cGMP standards. Capable of training and leading personnel while effectively managing multiple tasks in a fast-paced setting. Highest-signal resume keywords Biologics Processing Operations FDA Regulations Compliance CGMP Knowledge Leadership and Training Process Analysis Hard Skills Process Analysis Ultrafiltration Operation Chromatography Operation CIP System Operation SIP System Operation Centrifuge Operation Equipment Setup and Operation Documentation Completion Basic Measurements (pH, Turbidity, Conductivity) Forklift Operation Soft Skills Leadership Skills Interpersonal Skills Attention to Detail Proactive Attitude Time Management Industry Keywords Pharmaceutical Industry GMP Environment Clean-Room Manufacturing Biological Fluids Handling Safety Policies Tools & Technologies Touchscreen Operator Interface Terminals MS Office (Outlook, Word, Excel, PowerPoint) #J-18808-Ljbffr Jobtailor