Encapsulation Operator

Job Description

Job Description

What You’ll Do

The Encapsulation Operator is responsible for setting up, operating, monitoring, and cleaning capsule-filling equipment in support of oral solid dosage pharmaceutical manufacturing. This role ensures encapsulation activities are performed in accordance with approved batch records, SOPs, cGMPs, safety requirements, and Good Documentation Practices. The Encapsulation Operator works closely with Manufacturing, Quality Assurance, and Maintenance to maintain product quality, meet production schedules, and support safe, efficient operations.

Key Responsibilities:

• Set up and operate encapsulation equipment in accordance with approved batch records, SOPs, and equipment operating instructions.
• Monitor equipment operation and perform required in-process checks, including capsule appearance, integrity, closure, and fill weight, documenting results at specified intervals.
• Make authorized equipment adjustments within approved operating parameters to maintain consistent capsule quality and process performance.
• Identify and promptly report equipment malfunctions, process deviations, and out-of-specification in-process results; coordinate troubleshooting with supervision, Quality Assurance, and Maintenance.
• Accurately complete batch records, equipment logbooks, material reconciliations, and other manufacturing documentation contemporaneously and in accordance with Good Documentation Practices.
• Perform equipment disassembly, cleaning, reassembly, and changeovers as trained and authorized, and support required line clearance activities.

What We’re Looking For

Experience:

• Minimum of 3 years of hands-on encapsulation experience in pharmaceutical manufacturing required .
• Demonstrated experience setting up, operating, cleaning, and troubleshooting capsule-filling equipment in an oral solid dosage manufacturing environment.
• Experience performing in-process checks, completing batch manufacturing records, and following cGMP requirements.

Education:

• High school diploma or equivalent required.
• Technical training or coursework in pharmaceutical manufacturing, mechanical technology, or a related field preferred.

Skills & Knowledge:

• Strong working knowledge of cGMPs, Good Documentation Practices (GDP), SOPs, and batch manufacturing records.
• Knowledge of encapsulation processes, capsule-filling equipment, equipment cleaning, and changeover procedures.
• Ability to identify capsule defects, recognize process inconsistencies, and make authorized adjustments or escalate issues appropriately.
• Ability to perform basic mathematical calculations for weights, quantities, yields, and material reconciliation.
• Strong attention to detail, mechanical aptitude, and ability to follow written and verbal instructions.
• Effective communication and teamwork skills, with the ability to work independently within established procedures.

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 positions (Monday–Friday), with openings on 1st and 2nd shift.
• 1st Shift: 7:00 AM – 3:30 PM
• 2nd Shift: 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.