Production Operator - Cleanroom Manufacturing

Production Operator – Cleanroom Manufacturing

Job Summary

We are seeking a dependable and detail-oriented Production Operator to join our manufacturing team. In this role, you will operate production equipment used for aseptic filling, labeling, inspection, and packaging of bottles and vials while maintaining the highest standards of quality, safety, and efficiency.

This position requires working in an ISO 7 cleanroom and Controlled Non-Classified (CNC) manufacturing environment while following Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and company quality requirements. The ideal candidate has previous manufacturing experience, enjoys working in a fast-paced environment, and is committed to producing high-quality products.

Job Responsibilities

• Operate aseptic filling, labeling, and packaging equipment according to established procedures.
• Perform equipment setup, operation, shutdown, cleaning, and changeovers.
• Operate multiple production machines while maintaining quality and productivity.
• Monitor equipment performance and clear minor jams or production interruptions when appropriate.
• Report equipment malfunctions, product defects, or safety concerns to the Line Lead or Supervisor.
• Perform visual inspections of bottles, vials, labels, and finished products to ensure quality standards are met.
• Complete production work orders and manufacturing documentation accurately using both paper and electronic systems.
• Maintain accurate and legible production records in accordance with GMP requirements.
• Follow Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all company safety policies.
• Replenish production materials and supplies as needed throughout the shift.
• Perform routine housekeeping and maintain a clean, organized work area.
• Support production activities outside your assigned work area when needed.
• Perform basic mathematical calculations required during manufacturing processes.
• Utilize Microsoft Office, SAP, and other production software to complete manufacturing transactions and documentation.
• Work collaboratively with production, quality, and maintenance teams to meet daily production goals.
• Wear required cleanroom garments, including coveralls, hood, gloves, and shoe covers while working in controlled manufacturing environments.

Qualifications

• High school diploma or GED required.
• Previous manufacturing experience in a GMP-regulated environment preferred.
• Experience working in an ISO-regulated or cleanroom manufacturing environment preferred.
• Experience operating production or manufacturing equipment.
• Basic computer skills, including Microsoft Office and data entry.
• Experience with SAP or other ERP systems is a plus.
• Strong attention to detail and commitment to quality.
• Ability to follow written work instructions and Standard Operating Procedures.
• Strong communication and teamwork skills.
• Ability to lift up to 20 pounds.
• Ability to wear required cleanroom gowning and personal protective equipment (PPE).

Preferred Skills

• Production Operator
• Manufacturing Operator
• Aseptic Filling
• Bottle Filling
• Vial Filling
• Packaging
• Labeling
• Machine Operation
• Equipment Setup
• Equipment Cleaning
• Quality Inspection
• Visual Inspection
• Medical Device Manufacturing
• Pharmaceutical Manufacturing
• Good Manufacturing Practices (GMP)
• ISO 7 Cleanroom
• Controlled Non-Classified (CNC)
• Standard Operating Procedures (SOPs)
• SAP
• ERP Systems
• Production Documentation
• FDA-Regulated Manufacturing
• Lean Manufacturing
• Continuous Improvement
• Attention to Detail
• Teamwork
• Communication

Physical Requirements

• Ability to stand and walk for extended periods throughout the shift.
• Ability to perform repetitive hand and arm movements.
• Frequent bending, reaching, squatting, and lifting up to 20 pounds.
• Ability to work in an ISO 7 cleanroom while wearing required PPE and gowning.
• Ability to perform detailed visual inspections throughout the workday.

Why Join Our Team?

• Competitive pay
• Full-time opportunity
• Clean, climate-controlled manufacturing environment
• Comprehensive training
• Career advancement opportunities
• Opportunity to work with advanced manufacturing equipment
• Supportive team environment
• Be part of a team that manufactures products that improve patients' lives