Manufacturing Supervisor (1st & 2nd Shift)
7 days ago
Newtown
Job Description 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 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 Manufacturing Supervisor plays a critical role in maintaining inspection-ready operations, resolving shift-level issues, and driving safe, compliant, and efficient manufacturing execution across the production floor. Key Responsibilities: • Supervise and coordinate daily manufacturing activities across assigned oral solid dosage production areas, including weighing, blending, compression, coating, encapsulation, granulation, and drying., • 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., • Partner with Quality Assurance, Quality Control, Validation, Warehouse, Engineering, and Maintenance to resolve operational issues and support reliable manufacturing output., • Drive timely follow-up and support closure of deviations, investigations, CAPAs, and other quality system actions related to manufacturing operations., • Verify that personnel training, qualifications, and required certifications are current before work is assigned., • Conduct routine floor audits to ensure compliance with cGMP, GDP, PPE, housekeeping, line clearance, and area status requirements., • Review shift performance metrics, including output, downtime, labor usage, and rejects, and implement corrective actions as needed., • Provide coaching, performance feedback, and employee development support in partnership with HR and Manufacturing Management., • Support hiring, onboarding, succession planning, and continuous improvement initiatives within the manufacturing organization. What We’re Looking For Experience: • Minimum of 5 years of pharmaceutical manufacturing experience in a cGMP-regulated environment required., • At least 2 years of lead or supervisory experience in pharmaceutical manufacturing strongly preferred., • 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. Education: • High school diploma or equivalent required., • Bachelor’s degree in a scientific, engineering, or related discipline preferred., • Equivalent combinations of education and directly relevant manufacturing leadership experience will be considered. Skills & Knowledge: • Strong knowledge of cGMP requirements, FDA expectations, and applicable safety and regulatory standards., • Experience reviewing, approving, and troubleshooting batch records, SOPs, logbooks, and production documentation., • Familiarity with validation activities, including equipment qualification and related manufacturing support., • Strong leadership, coaching, and team development skills in a fast-paced manufacturing environment., • Strong problem-solving, root cause analysis, and decision-making ability., • Proficiency with Microsoft Office applications and familiarity with ERP or manufacturing inventory systems preferred., • Strong written and verbal communication skills with the ability to work effectively across Manufacturing, Quality, Warehouse, Engineering, Validation, and Maintenance. 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 (1st Shift: Monday–Friday, 7:00 AM – 3:30 PM; 2nd Shift: Monday–Friday, 3:00 PM – 11:30 PM) Company DescriptionKVK 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.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.