KVK TECH H-1B Visa Sponsorship Jobs USA

INTRODUCTION

KVK Tech is seeking an experienced Manufacturing Group Lead to join our team in Newtown, PA.

ROLE AND RESPONSIBILITIES

The Manufacturing Supervisor is responsible for overseeing daily oral solid dosage manufacturing operations to ensure production activities are executed safely, efficiently, and in compliance with cGMP requirements, approved procedures, and established production schedules. This role provides direct leadership to Manufacturing Group Leads and Operators across assigned production areas, with accountability for staffing deployment, floor oversight, documentation quality, training compliance, and operational performance. The ideal candidate will demonstrate strong leadership in a regulated manufacturing environment, sound judgment in managing production execution and personnel, and the ability to maintain inspection-ready operations while driving safe, compliant, and efficient performance.

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

• Supervise and coordinate daily oral solid dosage manufacturing activities across assigned production areas, including weighing, blending, compression, coating, encapsulation, granulation, and drying, to ensure safe, compliant, and efficient execution.
• Direct staffing assignments, room coverage, and labor utilization based on production priorities, training status, and operational needs.
• Oversee floor execution through active presence in manufacturing areas and ensure Group Leads and Operators follow batch records, SOPs, safety requirements, and cGMP expectations.
• Review and approve production documentation, including batch records, equipment logs, and supporting forms, for accuracy, completeness, and compliance with Good Documentation Practices.
• Lead the initial assessment and escalation of production, quality, safety, staffing, and equipment issues impacting shift performance, and partner cross-functionally to support timely resolution.
• Conduct employee coaching, performance feedback, and development activities while supporting training compliance, onboarding, and succession planning for manufacturing personnel.
• Support deviations, investigations, CAPAs, validation activities, and continuous improvement initiatives related to manufacturing operations.

BASIC QUALIFICATIONS

We are looking for applicants with:

• High school diploma or equivalent required; Bachelor’s degree in a scientific, engineering, or related discipline preferred.
• Minimum 5 years of pharmaceutical manufacturing experience in a cGMP-regulated environment required, including at least 2 years in a lead or supervisory capacity.
• Demonstrated experience managing teams, overseeing production schedules, and supporting compliant manufacturing execution in a regulated environment required.
• Prior oral solid dosage manufacturing experience strongly preferred.
• Strong knowledge of cGMP requirements, FDA expectations, Good Documentation Practices, and applicable safety and regulatory standards.
• Experience reviewing, approving, and troubleshooting batch records, SOPs, logbooks, and related production documentation.
• Strong leadership, coaching, problem-solving, and communication skills, with the ability to work effectively with multiple departments.

PREFERRED QUALIFICATIONS

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.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.