Encapsulation Operator III (3:30pm-12:00am)

Job Description

Job Description

Encapsulation Operator III

About KVK Tech

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

What You’ll Do

The Encapsulation Operator III serves as a highly experienced technical resource within pharmaceutical encapsulation operations. This position independently performs complex equipment setups, changeovers, operation, cleaning, and advanced troubleshooting while maintaining strict compliance with approved batch records, SOPs, cGMP, safety, and quality requirements. The Encapsulation Operator III also supports operator training, process improvement, deviation investigations, and the resolution of recurring equipment or process problems.

Key Responsibilities:

• Independently set up, operate, monitor, clean, and troubleshoot assigned encapsulation machines and ancillary equipment across a variety of products, capsule sizes, formulations, and processing requirements.
• Execute complex product changeovers, including the installation, inspection, adjustment, and verification of machine parts, dosing components, tooling, and product-contact equipment.
• Monitor equipment and process performance, make authorized adjustments, and resolve issues involving capsule weight variation, capsule defects, material flow, feeding, locking, equipment jams, reject rates, and production output.
• Perform and verify required in-process checks, material reconciliations, yield calculations, equipment inspections, and production documentation.
• Serve as a technical resource for encapsulation operations by training operators, demonstrating proper equipment practices, and assisting with the resolution of complex or recurring manufacturing problems.
• Support deviation investigations, root-cause analysis, corrective and preventive actions, process improvements, and revisions to SOPs, batch records, or equipment procedures.
• Coordinate significant equipment or quality issues with Production supervision, Maintenance, Engineering, and Quality while maintaining a clean, safe, compliant, and inspection-ready manufacturing area.

What We’re Looking For

Education:

• High school diploma or equivalent required.
• Technical training or an Associate’s degree in Manufacturing, Pharmaceutical Technology, Industrial Technology, Mechanical Technology, or a related field preferred.

Experience:

• 5 or more years of pharmaceutical or nutraceutical manufacturing experience, including substantial direct hands-on experience with encapsulation equipment.
• Demonstrated mastery of encapsulation machine setup, operation, disassembly, cleaning, reassembly, changeovers, adjustment, and troubleshooting.
• Experience operating encapsulation equipment across multiple products, formulations, capsule sizes, or processing requirements.
• Demonstrated ability to diagnose and resolve complex equipment, material-flow, capsule-quality, and process-performance issues.
• Experience training or mentoring operators and serving as a technical resource within a cGMP manufacturing environment.
• Experience supporting deviations, investigations, root-cause analysis, corrective actions, or manufacturing process improvements preferred.
• Level III placement is based on demonstrated equipment mastery, technical capability, and scope of responsibility—not tenure alone.

Skills & Knowledge:

• Advanced knowledge of pharmaceutical encapsulation processes, cGMP requirements, Good Documentation Practices, SOPs, batch records, and controlled manufacturing procedures.
• Advanced mechanical aptitude and demonstrated mastery of encapsulation equipment, machine components, dosing systems, change parts, and ancillary equipment.
• Ability to diagnose and resolve complex capsule defects, weight variation, feeding problems, material-flow issues, equipment jams, and abnormal operating conditions.
• Ability to analyze process performance, recognize developing problems, and make authorized equipment or process adjustments within established parameters.
• Strong understanding of in-process controls, material accountability, yield calculations, reconciliation requirements, and contamination-control practices.
• Ability to train and mentor operators, communicate technical information clearly, and collaborate effectively with Production, Maintenance, Engineering, and Quality.
• Strong leadership, problem-solving, documentation, organization, and decision-making skills.
• Ability to work around pharmaceutical powders while wearing required personal protective equipment.
• Ability to stand for extended periods and regularly bend, reach, push, pull, and lift or move materials weighing up to 50 pounds, with or without reasonable accommodation.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 3:30 PM–12:00 AM)

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

Company Description

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.