Manufacturing Lead (Nocturno 4X3 M-S)

Working under limited supervision and following detailed verbal, written, and hands-on instructions, the Manufacturing Lead is responsible for leading and coordinating a team of Production Associates to achieve productivity, quality, safety, training, and operational goals. This role serves as the first line of support for production-related issues, personnel management, material control, inventory accuracy, and manufacturing documentation while ensuring compliance with company procedures and regulatory requirements.

The Manufacturing Lead plays a critical role in maintaining line balance, supporting operator development, coordinating daily production activities, managing ERP transactions, and driving compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) within a regulated manufacturing environment.

WORK SCHEDULE / HOURS: Turno Nocturno 4x3 Miércoles a Sábado 6:00 p.m. – 6:00 a.m.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Perform complex tasks in the manufacturing area.

• Coordinate, support, and monitor daily production activities in accordance with approved procedures, Work Instructions (WIs), Operating Procedures (OPs), and Employee Operating Procedures (EOPs).

• Lead and manage a team of Production Associates to meet productivity, quality, delivery, and safety goals.

• Generate daily staffing and workstation assignments to ensure adequate production coverage.

• Reassign associates as needed to maintain balanced production lines and achieve operational objectives.

• Provide leadership, coaching, mentoring, and support to Production Associates.

• Resolve minor personnel issues and escalate employee concerns when appropriate.

• Support employee development through training, certification, and coaching activities.

• Maintain training compliance and certification coverage for critical manufacturing processes.

• Perform and support operator training and qualification activities.

• Serve as the first point of escalation for production defects, process concerns, and quality issues before escalation to Quality or Engineering teams.

• Review, identify, and support investigation of process defects and manufacturing issues.

• Coordinate material requests and support inventory control activities for production operations.

• Execute material consumption transactions and inventory movements within the ERP system.

• Ensure manufacturing transactions and production records are completed accurately and in a timely manner.

• Monitor inventory accuracy and support daily material management activities.

• Utilize ERP systems such as Epicor, SAP, Oracle, or similar manufacturing systems to support production operations.

• Accurately complete manufacturing documentation, including production records, travelers, logbooks, and supporting documentation.

• Maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

• Read, interpret, and follow Work Instructions, EOPs, engineering drawings, and manufacturing documentation.

• Perform data collection activities and enter information into manufacturing databases and tracking systems.

• Conduct basic to complex visual inspections according to applicable procedures and work standards.

• Utilize microscopes and other inspection equipment when required.

• Maintain clean and organized workstations, material areas, and production environments.

• Obtain and coordinate supplies and materials from warehouse operations when required.

• Support troubleshooting of basic equipment, computer, Servoy, Epicor, and production-related issues.

• Communicate operational issues to Supervision, Engineering, Quality, Maintenance, and other support groups.

• Track and support achievement of departmental KPI’s, productivity goals, quality metrics, and operational targets.

• Participate in continuous improvement initiatives, productivity projects, and safety improvements.

• Communicate production updates and operational concerns through email and other communication tools.

• Complete required production, safety, environmental, and quality training.

• Follow all corporate, quality, safety, and manufacturing procedures.

• Ensure personal and company compliance with all Health, Safety, Environmental, and Quality requirements.

SUPERVISORY RESPONSIBILITIES

Supervise work through planning, scheduling, coordinating daily activities, and reviewing the completion of assigned tasks, and supervises operators

Supervision

Immediate supervision: receives guidance related to work activities and objectives, while independently directing daily production activities and personnel assignments within assigned manufacturing areas.

EDUCATION AND/OR EXPERIENCE

• High School Diploma required.

• Technical education, university studies, or coursework in Engineering, Industrial Production, Business Administration, Supply Chain, or related disciplines is desirable.

• 3 to 6 years of experience in manufacturing environments.

• Experience in the Medical Device industry is strongly preferred.

• Pharmaceutical manufacturing experience may also be considered due to similarities in quality systems, documentation practices, and regulatory requirements.

• Demonstrated experience leading or coordinating manufacturing personnel is required.

• Experience supporting production operations and manufacturing teams is required.

• Experience working with ERP systems such as Epicor, SAP, Oracle, or similar manufacturing systems is strongly preferred.

• Experience with inventory control, material transactions, production reporting, and manufacturing documentation is highly desirable.

• Basic computer skills including: Microsoft Excel, Microsoft Word, Outlook and Manufacturing systems and databases

OTHER SKILLS AND ABILITIES

• Ability to work varying shifts and overtime as required.

• English is not required for this position; basic English proficiency is considered a plus.

• Ability to complete company and department training requirements.

• Ability to work effectively in a team environment.

• Demonstrated experience leading and coaching production personnel.

• Knowledge of Good Manufacturing Practices (GMP).

• Knowledge of Good Documentation Practices (GDP).

• Experience working with production KPI’s and operational performance metrics.

• Experience supporting training and operator certification activities.

• Strong organizational skills and ability to manage multiple priorities.

• Ability to work effectively under pressure while maintaining quality and productivity standards.

• Experience using ERP systems such as Epicor, SAP, Oracle, or similar manufacturing software.

• Experience in Medical Device manufacturing strongly preferred.

• Ability to distribute work and communicate instructions effectively.

• Ability to follow complex verbal and written instructions.

• Ability to read and interpret complex engineering drawings and manufacturing documentation.

• Ability to interpret machine performance data and manufacturing records.

• Ability to apply regulatory requirements (ISO, GMP, QSR) in daily activities.

• Ability to use microscopes, optical comparators, video systems, and magnification equipment.

• Ability to use measurement tools including calipers, micrometers, gauges, rulers, thermometers, and pull-testers.

• Strong problem-solving, communication, and leadership skills.

PREFERRED QUALIFICATIONS

• Medical Device manufacturing experience.

• Pharmaceutical manufacturing experience.

• ERP experience (Epicor preferred; SAP or Oracle acceptable).

• Experience supporting training and certification programs.

• Experience managing production KPI’s and operational metrics.

• Experience coordinating inventory and material control activities.

• Experience using microscopes and visual inspection equipment.

• Experience leading production teams in regulated manufacturing environments.

MANUAL DEXTERITY

Manual dexterity sufficient to reach, handle items, work with fingers, and perceive attributes of objects and materials.

VISION REQUIREMENTS

Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated, and/or air-conditioned indoor manufacturing environment with adequate ventilation.

PHYSICAL DEMANDS

• Lifting or carrying items.

• Moderate noise (manufacturing environment and production equipment).

Physical Activity Level

Light physical activity performing productive, technical, and supervisory responsibilities within manufacturing operations.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those encountered while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this role, the employee frequently works near moving mechanical parts and manufacturing equipment. The employee may occasionally be exposed to airborne particles, fumes, chemicals, electrical equipment, and cleanroom environments. Appropriate PPE and cleanroom garments may be required. Close vision and visual inspection capabilities are essential and must meet company standards.

COMMENTS

This position description is an outline of the major recurring responsibilities of the role and is not intended to be all-inclusive. Employees may be assigned other duties, projects, and responsibilities as required.

Success in this position requires strong leadership skills, experience managing manufacturing personnel, working knowledge of ERP systems, understanding of GMP/GDP requirements, and the ability to support production operations in a highly regulated manufacturing environment. Medical Device experience is strongly preferred, while Pharmaceutical manufacturing experience may also be considered.