ENCAPSULATION MECHANIC / OPERATOR in SOMERSET, New Jersey at ASPIRE PHARMACEUTICALS INC

The Encapsulation Mechanic / Operator is responsible for setting up, operating, assembling, disassembling, cleaning, and troubleshooting encapsulation machines and related equipment. This position ensures consistent and efficient production of soft gelatin capsules in compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (cGMPs), and safety standards. The role requires strong mechanical aptitude, attention to detail, and the ability to maintain equipment performance to meet production quality and quantity standards.

• Assemble, disassemble, clean, and set up encapsulation machines and auxiliary equipment as per SOPs.

• Operate encapsulation equipment efficiently to meet daily production targets while ensuring capsule quality and consistency.

• Perform equipment adjustments, preventive maintenance, and minor repairs as required.

• Troubleshoot mechanical issues to minimize downtime and coordinate with maintenance when necessary.

• Record equipment and production data accurately in batch records and logbooks.

• Follow all cGMP and safety regulations, including use of personal protective equipment (PPE).

• Maintain cleanliness and organization of the work area.

• Assist in training new operators or mechanics as needed.

• Ensure compliance with all company policies, SOPs, and FDA requirements.

• High school diploma or equivalent required.

• Minimum of 2+ year of experience in encapsulation, injection molding, tablet operations, or other mechanical/machine operation roles.

• Fluent English communication skills to read/interpret SOPs, complete documentation, and communicate issues effectively.

• Manual dexterity for handling tools and assembling/disassembling equipment.

• Physical ability to stand and walk for extended periods, and to push, pull, or lift up to 50 pounds.

• Ability to stand/walk for most of the work shift and perform repetitive operations.

• Periodically push/pull large containers (up to 500 lbs with wheels) and lift items up to 50 lbs.

• Exposure to moderate noise levels, warm temperatures, and oily/wet conditions—hearing protection and slip-resistant footwear required.

• Must wear required PPE, including protective eyewear, gloves, uniforms, hairnets, and steel-toed shoes.

• Must be able to perform job duties safely without endangering self or others.