Coating Operator (1st Shift - 7:00am-3:30pm)

Coating Operator (1st Shift)

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 Coating Operator serves as a senior, highly skilled production operator responsible for independently setting up, operating, and optimizing coating systems used in oral solid dosage (OSD) manufacturing. This role performs advanced troubleshooting, leads changeovers, and ensures the highest standards of quality, efficiency, and compliance in coating operations. The position also provides on-the-job training, technical guidance, and mentorship to junior operators while supporting continuous improvement and deviation investigations across Manufacturing.

Key Responsibilities:

• Independently set up, operate, and monitor coating systems and related OSD equipment (e.g., perforated pan coaters, air handling systems, dust collectors, and ancillary process units) in compliance with approved Master Batch Records (MBRs) and SOPs.
• Perform in-process testing and inspections to confirm coating weight gain, uniformity, and appearance meet established specifications.
• Troubleshoot coating process issues (e.g., spray patterns, drying, adhesion, weight variation) and implement corrective actions to minimize downtime and ensure consistent product quality.
• Lead or support complex equipment changeovers and cleaning procedures in accordance with validated and documented processes.
• Complete accurate, contemporaneous, and legible documentation in batch records, logbooks, and electronic systems following ALCOA+ data integrity principles.
• Review batch documentation for accuracy and completeness; communicate deviations or anomalies to Quality Assurance and Manufacturing Supervision.
• Partner with Quality Assurance, Technical Services, and Engineering to support process validations, equipment qualifications, and improvement initiatives.
• Serve as a subject matter expert (SME) for coating and other manufacturing processes, providing technical insight during investigations and CAPA implementation.
• Train and mentor Manufacturing Operator I and II personnel on equipment operation, documentation standards, and cGMP compliance.
• Recommend and support process optimization initiatives focused on improving yield, safety, and efficiency.
• Adhere to all safety protocols, PPE requirements, and 5S housekeeping standards in the manufacturing area.
• Perform other duties as assigned to support production goals and compliance requirements.

What We’re Looking For

Experience: Minimum 2-5 years of pharmaceutical manufacturing experience in a cGMP-regulated environment with demonstrated proficiency in two or more manufacturing processes, including coating operations.

Education: High school diploma or equivalent required; technical training or coursework in manufacturing or mechanical systems preferred.

Skills & Knowledge:
• Advanced knowledge of coating equipment, parameters, and process troubleshooting in oral solid dosage manufacturing.
• Strong understanding of cGMP, FDA regulations, and data integrity requirements.
• Proven ability to perform complex equipment setups, changeovers, and cleaning procedures.
• Experience conducting in-process testing and interpreting results to ensure batch compliance.
• Skilled in mentoring and training operators to maintain procedural consistency and quality.
• Excellent attention to detail, documentation accuracy, and problem-solving skills.
• Effective communication and collaboration across cross-functional teams.
• Commitment to safety, quality, and continuous improvement in all operations.

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 day-shift position. Flexibility required for overtime, weekend coverage, or alternate shifts based on production demands.