Encapsulation Operator

KVK Tech, Inc.; Newtown Township (Delaware County); On-site; USD 42,000 - 65,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental Insurance

Annual merit increases

Paid Time Off and Flexible Holidays

Job summary

KVK Tech, Inc. is seeking a skilled Encapsulation Operator to join the second-shift team in Newtown, PA.

The role involves setting up, operating, and monitoring encapsulation machines used in oral solid dosage manufacturing, with emphasis on cGMP and documentation compliance. Ideal candidates have at least 1 year encapsulation experience, strong attention to detail, and good problem-solving and communication skills.

Qualifications

• High school diploma or equivalent required.
• Minimum of 1 year of encapsulation experience in a solid oral dose commercial manufacturing environment.
• Strong working knowledge of cGMP requirements, Good Documentation Practices, SOPs, batch records, and controlled manufacturing procedures.

Responsibilities

• Set up, operate, and monitor encapsulation machines and related equipment according to Master Batch Records and SOPs.
• Verify blends, capsule shells, components, lot numbers, quantities, and material status before processing.
• Perform in-process checks for capsule weight, appearance, integrity, and product requirements.
• Monitor equipment and process performance; adjust to address weight variation, material-flow issues, capsule defects, jams, or other operating concerns; disassemble/clean/reassemble line as needed.
• Complete accurate entries in batch records, equipment logs, cleaning records, material reconciliations, yield calculations, and electronic systems.
• Coordinate with Production supervision and Quality regarding line clearances, equipment problems, deviations, investigations, and product-quality concerns.

Skills

Encapsulation experience

Attention to detail

Problem-solving

Documentation skills

Education

High school diploma or equivalent

1 year encapsulation experience

Job description

KVK Tech is seeking a skilled Encapsulation Operator to join our second-shift team in Newtown, PA.

The Encapsulation Operator will perform the setup, operation, monitoring, cleaning, and changeover of encapsulation machines and related equipment used in oral solid dosage (OSD) manufacturing. This position requires the ability to monitor encapsulation performance, perform required in-process checks, make appropriate equipment adjustments, and maintain strict compliance with cGMP and documentation requirements. Candidates may be considered at the Operator I, II, or III level based on their direct encapsulation experience, demonstrated equipment proficiency, troubleshooting ability, and overall technical capability.

This position’s responsibilities will include, but not be limited to the following:

• Set up, operate, and monitor encapsulation machines and related ancillary equipment according to approved Master Batch Records and standard operating procedures.
• Verify pharmaceutical blends, capsule shells, components, lot numbers, quantities, and material status before processing.
• Perform required in-process checks involving capsule weight, appearance, integrity, and other established product requirements.
• Monitor equipment and process performance and make authorized adjustments to address weight variation, material-flow issues, capsule defects, equipment jams, or other operating concerns. Perform equipment disassembly, cleaning, inspection, reassembly, product changeovers, and line-clearance activities according to approved procedures.
• Complete accurate and compliant entries in batch records, equipment logs, cleaning records, material reconciliations, yield calculations, and electronic systems.
• Coordinate with Production supervision and Quality regarding line clearances, equipment problems, process deviations, investigations, and product-quality concerns.

We are looking for applicants with:

• High school diploma or equivalent required.
• Minimum of 1 year of encapsulation experience in a solid oral dose commercial manufacturing environment.
• Strong working knowledge of cGMP requirements, Good Documentation Practices, SOPs, batch records, and controlled manufacturing procedures.
• Mechanical aptitude and the ability to identify and respond appropriately to capsule defects, weight variation, material-flow problems, and abnormal equipment conditions.
• Strong attention to detail, problem-solving skills, communication skills, and commitment to quality and safety.

What we offer:

• 401(k) with company match
• Health, vision, and dental Insurance
• Annual merit increases
• Paid Time Off and Flexible Holidays

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

All KVK Tech products are made in the USA in strictest accordance with FDA, DEA, and DEP guidelines.