Solid Dose Manufacturing Technician

Solid Manufacturing Technician I

The Solid Manufacturing Technician I is an entry-level role responsible for supporting the manufacturing of solid-dose pharmaceutical products, including granulation, blending, compression, encapsulation, and coating. The technician performs cleaning, equipment setup, material handling, and basic operation under direct supervision. This position ensures all activities follow cGMP requirements, SOPs, and safety standards to support consistent product quality and efficient production flow.

Essential Functions

Equipment Preparation & Operation

• Learns to operate and monitor solid-dose manufacturing equipment, including:
  • Granulators, blenders, oscillators, Fitzmill/Comill systems
  • Tablet presses (e.g., Kikusui Libra, Gemini, Rotapress, Nova)
  • Encapsulation equipment
  • Tablet coating equipment (e.g., coating pans, spray systems)
  • Dedusters, metal detectors, hardness testers, thickness gauges and scales
• Assists in assembling, disassembling, and cleaning equipment according to SOPs.
• Prepares rooms and equipment before and after manufacturing operations.
• Assists in charging materials into equipment under supervision, including coating solutions and slurry.
• Performs basic machine adjustments as directed to maintain product quality.

Material Handling

• Weighs and verifies raw materials with QA present, including excipients, and APIs
• Safely handles raw powders, granulated product, intermediates, and coating materials.
• Ensures materials are properly labeled, stored, and staged for production.

Product Quality & Compliance

• Follows detailed batch record steps and SOP instructions for all unit operations, including coating parameters.
• Conducts in-process checks with guidance, such as:
  • LOD testing
  • Tablet weight, hardness, thickness, friability
  • Coating weight gain and visual appearance checks
• Ensures all work requiring verification is checked by authorized personnel.
• Reports deviations or abnormal conditions immediately to section lead and supervisor.

Documentation

• Accurately documents all work in batch records, logbooks, and cleaning logs, including coating activities.
• Records measurements, observations, and process adjustments in real time.
• Ensures documentation complies with cGMP, GDP, and site requirements.
• Ensures all MasterControl training requirements are completed within the required timeframe and maintains proficiency in printing SOPs, cleaning checklists, and other controlled documents.

Cleaning & Maintenance

• Performs A, B, and S cleans of equipment and production rooms, including coating pans, spray guns, and solution tanks.
• Assists with minor preventive maintenance under supervision.
• Maintains clean and organized work areas to prevent contamination.

Safety Compliance

• Follows all safety procedures and PPE requirements, including those specific to handling solvents or coating materials.
• Reports unsafe conditions, equipment issues, or near-misses immediately to section lead and supervisor.
• Participates in required safety training.

Troubleshooting & Reporting

• Assists in basic troubleshooting of equipment issues across all areas, including coating systems.
• Escalates complex mechanical or process-related concerns to senior staff.

Other Responsibilities

• Participates in on-the-job training to progress toward independent operation in all manufacturing areas.
• Performs additional related duties to support departmental goals

Required Skills/Abilities

• Ability to follow detailed written and verbal instructions.
• Strong attention to detail and documentation accuracy.
• Basic math and mechanical aptitude.
• Dependable and able to work effectively in a team environment.
• Ability to safely lift up to 50 lbs and perform extended physical activity.

Required Education and Experience

• High school diploma or GED equivalent.
• No prior pharmaceutical experience required.
• Minimum of 1 year of experience in pharmaceutical, food, or other regulated manufacturing environments.

Preferred Education and Experience

• Experience in manufacturing, production, or mechanical work environments.
• Familiarity with cGMP, batch records, or regulated industry practices.
• Experience with solid-dose equipment or mechanical systems is a plus.

Position Type/Expected Hours of Work

Employment Type: Full-Time

Shift Schedule:

• First Shift : Monday - Friday, 6:00 AM - 2:30 PM

Flexibility for overtime or weekend work may be required.

Physical Demands

Ability to lift and handle up to 50 lbs frequently.

Prolonged standing, walking, bending, and reaching during operations.

Manual dexterity for equipment adjustments and coating spray components.

Work Environment

Pharmaceutical manufacturing environment with exposure to powders, solvents, and moving machinery.

Required PPE includes safety glasses, gloves, hearing protection, and appropriate garments.

Temperature and humidity may vary depending on processes.