Manufacturing Operator

Job Summary:Executes quality and manufacturing procedures to meet production demands and regulatory requirements.Ensures on-time production of pharmaceutical intermediates, semi-finished, and finished products meeting quality standards.Assists in setting up equipment operating specifications, SOPs, and improving manufacturing techniques.Supports equipment maintenance, calibration, and troubleshooting.Night Shift Hours: Alternating Wednesdays, plus every Thursday, Friday, and Saturday from 6:00 PM 6:30 AM .Key Responsibilities:Performs semi-routine tasks requiring judgment in problem-solving and recommendations.May guide lower-level personnel on assignments.Executes manufacturing operations per Manufacturing Records, cGMP, and SOPs in a cleanroom environment.Sets up, cleans, and sanitizes manufacturing areas and equipment under supervision.Operates production equipment per Manufacturing Records and SOPs (with supervision).Conducts in-process inspections and testing (with supervision).Accurately documents manufacturing activities in records, forms, labels, and logbooks.Verifies and confirms manufacturing steps performed by others.Follows all company health, safety, and environmental guidelines.Fully qualified to operate ~50% of manufacturing equipment .Other tasks as assigned.Minimum Qualifications:High School/GED + 3-5 years of related experience (or equivalent training).Must pass medical clearance to wear a respirator (PAPR) for full shifts.Must be able to gown/de-gown in 3 layers of cleanroom attire (Tyvek jumpsuit) .Must comply with regulatory standards (FDA, ISO 13485, etc.).Required Skills & Certifications:12-hour shift availability.20% Shift Differential.Experience in production/manufacturing.Comfortable wearing Tyvek suit & respirator.Schedule: 3 days one week, 4 days the next (with OT on 4-day weeks).