Assembler / Packaging Operator / Machine Operator

Device Assembly & Packaging (DAP) Operator

Schedule: 12-hour rotating shift (2-2-3 schedule)

Overview

Our client is seeking Device Assembly and Packaging (DAP) Operators to support manufacturing operations at their pharmaceutical production facility in North Carolina. This role is responsible for executing device assembly and packaging processes while operating and monitoring manufacturing equipment in a regulated GMP environment.

The DAP Operator will help ensure the safe, compliant, and efficient production of pharmaceutical products by adhering to established procedures, maintaining accurate production documentation, and supporting operational goals related to safety, quality, and productivity.

Responsibilities

Manufacturing Operations

• Operate, monitor, and adjust manufacturing equipment used in device assembly and packaging operations.
• Support production schedules while ensuring compliance with safety, quality, and regulatory standards.
• Assist in troubleshooting equipment issues and escalating concerns as needed.

Production Documentation & Compliance

• Complete and verify execution documentation including:
  • Electronic Batch Records (EBR)
  • SAP transactions
  • Cleaning logs
• Maintain accurate and timely documentation in accordance with current Good Manufacturing Practices (cGMP) and regulatory requirements.

Safety & Quality

• Maintain a safe work environment and exemplify safe working practices while supporting site Health, Safety, and Environmental (HSE) goals.
• Follow all procedures, quality systems, and operating techniques to ensure consistent production and product quality.

Operational Support & Collaboration

• Serve as a liaison between operations and support functions to ensure smooth production operations.
• Contribute to departmental performance improvements including:
  • Reducing deviations
  • Increasing productivity
  • Improving safety metrics
  • Maintaining training compliance.Required Qualifications
• High School Diploma or GED.
• 4-8 years of experience in pharmaceutical or GMP-regulated manufacturing environments.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Basic computer proficiency including Microsoft Office and general desktop software.
• Ability to communicate effectively in English (written and verbal).

Preferred Qualifications

• Experience working with Manufacturing Execution Systems (MES) or electronic batch records.
• Familiarity with SAP transactions in a manufacturing environment.
• Knowledge of Lean manufacturing principles (5S).Additional Information
• Position operates on a 12-hour rotating 2-2-3 shift schedule, including weekends and potential overtime.
• Must be able to wear required personal protective equipment (PPE) including safety glasses, gloves, and steel-toed shoes.
• Physical requirements include standing for extended periods (up to 12 hours) and lifting up to 35 lbs.