Assistant Manager, Packaging

Job Description

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 Assistant Manager, Packaging supports the Packaging Manager in leading the daily operations of the Packaging Department within a regulated oral solid dosage pharmaceutical manufacturing environment. This role provides operational leadership across packaging shifts, lines, and personnel to ensure production schedules are achieved safely, efficiently, and in compliance with cGMP, FDA, DEA, OSHA, and company requirements. The Assistant Manager coordinates closely with Packaging Supervisors and cross-functional departments, supports employee development and performance management, and serves as a designated departmental leader in the Packaging Manager’s absence.

Key Responsibilities:

• Support the Packaging Manager in overseeing daily packaging operations and ensuring compliance with approved procedures, cGMP requirements, safety standards, and production expectations.
• Provide leadership and direction to Packaging Supervisors and other packaging personnel across assigned shifts, lines, or operational areas.
• Coordinate daily and weekly packaging schedules, staffing assignments, material readiness, equipment availability, and production priorities.
• Monitor packaging line performance, schedule attainment, labor utilization, downtime, waste, and other departmental performance indicators.
• Review packaging batch records, logbooks, reconciliation records, cleaning documentation, and production reports for accuracy, completeness, and timely completion.
• Collaborate with Quality Assurance, Manufacturing, Warehouse, Shipping, Engineering, Maintenance, and other departments to resolve issues and maintain production flow.
• Support packaging-related deviations, investigations, CAPAs, change controls, root cause analyses, and other Quality System activities.
• Identify recurring production issues and implement or recommend process improvements to increase efficiency, reduce downtime, and minimize waste.
• Coach and develop Packaging Supervisors, Line Leaders, Operators, Material Handlers, and Mechanics to strengthen performance, accountability, technical capability, and compliance.
• Ensure packaging personnel receive required training on SOPs, cGMP, ALCOA+, data integrity, safety procedures, equipment operation, and departmental expectations.
• Assist with employee performance management, attendance concerns, coaching, corrective actions, and staffing recommendations in coordination with the Packaging Manager and Human Resources.
• Support new product introductions, packaging line trials, equipment qualifications, process validations, and continuous improvement initiatives.
• Ensure packaging information is entered accurately and timely into ERP and production reporting systems.
• Prepare and communicate production updates, performance metrics, staffing concerns, operational risks, and departmental priorities to management.
• Support internal audits and regulatory inspections by maintaining inspection readiness and assisting with document retrieval and operational walkthroughs.
• Serve as the designated departmental leader in the absence of the Packaging Manager within assigned authority.

What We’re Looking For

Experience:

• Minimum of 6–9 years of progressive experience in pharmaceutical packaging, pharmaceutical manufacturing, or another cGMP-regulated production environment.
• Minimum of 2–3 years of leadership, supervisory, or management experience overseeing production employees, packaging lines, or manufacturing operations.
• Demonstrated experience coordinating production schedules, staffing, equipment availability, material readiness, and cross-functional operational support.
• Experience reviewing batch records, reconciliation records, production documentation, and packaging performance data.
• Experience supporting deviations, investigations, CAPAs, change controls, equipment qualifications, or continuous improvement activities preferred.
• Experience coaching supervisors, developing production employees, and addressing performance or compliance concerns.
• Experience within oral solid dosage pharmaceutical packaging strongly preferred.

Education:

• High school diploma or equivalent required.
• Bachelor’s degree in Business Administration, Operations Management, Engineering, Pharmaceutical Sciences, or a related field preferred.
• An equivalent combination of education, technical training, and relevant pharmaceutical packaging experience may be considered.

Skills & Knowledge:

• Strong working knowledge of pharmaceutical packaging operations, cGMP requirements, Good Documentation Practices, ALCOA+, and data integrity standards.
• Strong leadership, coaching, and team-development skills with the ability to provide direction across multiple packaging lines and shifts.
• Knowledge of packaging equipment operation, line setup, changeovers, reconciliation, line clearance, and operator-level troubleshooting.
• Ability to review batch records, logbooks, cleaning records, reconciliation documentation, and production reports.
• Working knowledge of deviations, investigations, CAPAs, change controls, root cause analysis, and other pharmaceutical Quality System processes.
• Familiarity with equipment qualification and packaging process validation activities, including IQ, OQ, and PQ.
• Ability to analyze production data, identify performance trends, investigate operational losses, and implement sustainable improvements.
• Proficiency with ERP or production reporting systems such as SYSPRO, SAP, JDE, or equivalent.
• Proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.
• Strong critical-thinking, problem-solving, organizational, and decision-making abilities.
• Excellent written and verbal communication skills for interaction with employees, management, and cross-functional departments.
• Ability to manage multiple priorities, respond to changing production requirements, and make timely operational decisions.

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, (primarily Monday–Friday, 9:00 AM-6:00 PM) with flexibility required to support packaging operations across multiple shifts, including occasional evenings, weekends, or extended hours based on business needs.

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.