Production Operator II/III or Senior Operator

Production Operator II/III or Senior Operator (Compression, Coating, Granulation, Encapsulation)

Job Summary

The Manufacturing/Production Operator performs essential functions related to the processing of pharmaceutical drug products. This role ensures strict compliance with current Good Manufacturing Practices (cGMP), customer requirements, and Standard Operating Procedures (SOPs).

Operators follow standard procedures to complete tasks of varying scope, sequence, complexity, and timing. They apply their skills and knowledge to identify issues and contribute to improvements in efficiency, throughput, and quality. Key responsibilities include operating processes to meet assigned standards and schedules, participating in debriefs to understand and correct deviations, assisting in troubleshooting process issues, and ensuring the safe and efficient execution of all duties.

Key Accountabilities

• Operations: Operate pharmaceutical production machinery for processes such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, compressing, encapsulating, and coating. Use manufacturing and other commonly used equipment according to SOPs.
• Material Handling: Follow written SOPs to ensure material purity. Properly use scales, including printouts, zeroing, setting tares, and daily calibration verification. Examine product labels, QC release tags, and Batch Production Records to verify raw materials.
• Cleaning and Changeovers: Clean manufacturing equipment and facilities according to established SOPs. Execute machine changeovers from batch to batch.
• Quality Control: Sample batches for quality testing as required. Perform required in-process product quality checks and document the results accurately.
• Scheduling and Standards: Operate processes to meet assigned schedules and standards/routers. Participate in debriefs to understand and correct deviations.
• Documentation: Complete manufacturing process documentation, including batch records, protocols, and logbooks, accurately and in detail. Meet requirements for entries on Batch Production pages and for completing and attaching dispensary and weight verification tickets. Verify manufacturing processes on BPRs accurately and promptly. Provide status updates and report operational challenges on status boards.
• Continuous Improvement: Assist in troubleshooting process issues and refer deviations to the supervisor. Participate in continuous improvement projects.
• Safety and Compliance: Adhere to cGMP, regulatory mandates, and quality requirements. Participate in safety teams, start-up discussions, and incident debriefings. Follow SOPs, policies, and procedures. Maintain a clean and organized work area.
• Training: Meet all training requirements, including company-required and machine-specific training.
• Teamwork and Collaboration: Share acquired knowledge to contribute to team and project success. Collaborate within the cross-functional work unit and, as needed, with contacts outside the unit or department.

Qualifications

We are looking for dedicated individuals with the following qualifications:

All Levels

• Education: High school diploma or equivalent experience.
• Experience: Production or retail store experience.
• Skills and Abilities:
  • Proficiency in operating production machinery.
  • Proficiency in equipment cleaning, including Master Clean/Surface Clean procedures.
  • Proficiency in sampling batches for quality testing.
  • Proficiency in performing basic equipment setups.
  • Ability to participate in continuous improvement projects.
  • Proficiency in manufacturing processes such as weighing, blending, granulation, compression, coating, encapsulation, or potent compound handling.
  • Basic math, reading, and legible writing skills, along with problem-solving abilities.
• Core Knowledge:
  • Knowledge of Good Manufacturing Practices (cGMP).
  • Knowledge of FDA regulations, GMP, lean manufacturing, and Six Sigma.
  • Solid working knowledge and skills in the procedures, techniques, tools, materials, and/or equipment needed for the position.

Operator-Level Specific Requirements

• Level II Operator:
  • Minimum of 2–5 years of pharmaceutical manufacturing experience.
  • Certification in the assigned area, as required, or demonstrated proficiency in relevant competencies.
• Level III Operator:
  • Minimum of 5 years of pharmaceutical manufacturing experience.
  • Certification in the assigned area, as required, or demonstrated proficiency in relevant competencies.

Preferred Qualifications

• Experience with pharmaceutical Glatt equipment, compression, and pan coating.
• Strong background in solid-dose manufacturing, particularly compression, encapsulation, coating, or Wurster coating.
• Experience in pharmaceutical granulation and blending.
• Ability to clean, set up, and operate advanced equipment, including tablet presses and encapsulation machines (e.g., Fette 3200i, Fette P 3030, MG2 Planeta, and Korsch XM 12).

Physical Requirements and Working Environment

• Ability to stand for extended periods, including shifts of up to 12 hours.
• Ability to lift and maneuver at least 50 pounds.
• Ability to climb ladders.
• Ability to wear a respirator and pass associated tests and requirements.
• Ability to wear all required personal protective equipment (PPE), including safety glasses, earplugs, and safety shoes.