POSITION SUMMARY

The Soft gel Encapsulation Machine Operator is responsible for the safe operation, set-up, and cleaning of the soft gel encapsulation machine. Manufactures soft gels according to written instructions and specification. Ensures compliance with standard operating procedures, safety rules and current good manufacturing practices.

ESSENTIAL FUNCTIONS 

Reasonable Accommodations Statement

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. 

Essential Function Statement(s)

• Competently operate encapsulation production equipment independently
• Assure applicable SOPs are followed and production is performed in accordance with written procedures.
• Provide “hands on” training to new encapsulation machine operators
• Document activities in logbooks incorporating good documentation practices
• Disassemble and clean encapsulation machines and related equipment
• Assemble and set up encapsulation machines and related equipment
• Clean Tumblers, working area and raw material/gelatin tanks
• Adhere to batch record specifications and keep the encapsulation process in control
• Perform in process checks for fill weight variation, temperature variation, gelatin ribbon thickness, capsule length, seam check and capsule size
• Practice protective handling of machinery tooling of the encapsulation machine including but not limited to die rolls, thickness gauge, thermometers, and scales/balances
• Document in process checks in the Production Batch Record following GOOD Documentation Practices (GDPs)
• Check for Soft Gel leaks inside the tumblers and at the exit bin of the last tumbler as needed
• Ensure the Spreader’s task completion is correct such as checking each tumbler basket is up and running correctly, spread soft gels on trays and transfer stacks into drying rooms/tunnels, fill out proper documentation for the stacks and drying tunnel/drying room
• Check machines and equipment for proper tag status (Ex.  To be Cleaned, Operating Tag, Ready to use, etc.)
• Control loss and waste of materials
• Ensure transfer bottles or spray bottles are properly labeled
• Report out-of-specification capsules to Lead and/or Shift Supervisor
• Wear the required personal protective equipment
• Adhere to gowning procedures
• Operate equipment in a safe manner
• Notify management of abnormal activities
• Assure MFG, equipment is in proper working order and initiate maintenance work orders when necessary, with Lead, Shift Supervisor
• Performs other duties as assigned.

POSITION QUALIFICATIONS 

Competency Statement(s) 

• Positive – Ability to view all situations with a positive attitude. 
• Innovative – Ability to look beyond the standard solutions and “think outside the box”.
• Detail Oriented – Ability to pay attention to the minute details of a project or task.
• Enthusiastic – Ability to bring energy to the performance of a task.
• Friendly – Ability to exhibit a cheerful demeanor toward others.
• Initiative – Ability to make decisions or take actions to solve a problem or reach a goal.
• Organized – Possessing the trait of being organized or following a systematic method of performing a task.
• Reliability – The trait of being dependable and trustworthy.

SKILLS & ABILITIES 

Education: 

• Minimum High School Diploma or equivalent.
   

Experience: 

• 1–2 years of experience in a manufacturing environment.
• 3+ years’ experience in the pharmaceutical industry is preferred.
• Previous experience working with softgel encapsulation equipment preferred.
• Experience operating and/or working around high-pressure manufacturing equipment preferred.

Technical Skills & Abilities:

• Strong mechanical aptitude and ability to troubleshoot equipment issues.
• Must be mechanically inclined.
• Ability to safely operate, monitor, and maintain high-pressure production equipment in accordance with SOPs and safety standards.