Encapsulation Operator

KVK Tech, Inc.; Newtown (PA); Presencial; USD 42.000 - 58.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) with company match

Health, vision, and dental insurance

Childcare expense reimbursement

Tuition reimbursement

Annual bonus eligibility

Annual merit increases

Paid Time Off and Flexible Holidays

Descripción de la vacante

KVK Tech, Inc. in Newtown, PA is seeking a skilled Encapsulation Operator for the second shift. You will set up, operate, and monitor encapsulation machines, verify components and lot numbers, and maintain strict cGMP documentation.

The role requires 1 year encapsulation experience and strong attention to detail, with opportunities for growth from Operator I to III levels based on experience and proficiency.

Formación

• High school diploma or equivalent required.
• 1 year encapsulation experience in solid oral dose manufacturing preferred.
• Knowledge of cGMP, documentation practices, SOPs, and batch records.

Responsabilidades

• Set up, operate, and monitor encapsulation machines per Master Batch Records and SOPs.
• Verify blends, capsule shells, lot numbers, quantities, and material status.
• Perform in-process checks on weight, appearance, integrity, and product specs.
• Monitor performance and adjust for weight variation, material-flow, defects, or jams.
• Document batch records, logs, cleaning records, reconciliations, and yields.
• Coordinate with Production and Quality on line clearances and deviations.

Conocimientos

Mechanical aptitude

Attention to detail

Problem-solving skills

Communication skills

cGMP knowledge

Educación

High school diploma or equivalent

Herramientas

Encapsulation equipment

Batch records systems

Descripción del empleo

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
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• 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.