Job Summary:

The Tooling Specialist is responsible for the management, maintenance, tracking, optimization, and lifecycle oversight of all compression and encapsulation tooling used in solid dose manufacturing. This role supports efficient production operations by ensuring tooling readiness, executing rapid changeovers, troubleshooting tooling-related issues, and maintaining compliance with GMP standards under 21 CFR Part 111. The Tooling Specialist serves as the facility's subject matter expert for tablet press and encapsulation tooling systems and plays a critical role in maximizing production uptime, tooling performance, product quality, and dosing efficiency. The position reports directly to the Dosing Manager.

Job Duties & Responsibilities:

Safety & Workplace Practices

Support lockout/tagout (LOTO) procedures when working on equipment as required.
identify and report unsafe conditions, equipment hazards, or near-miss incidents immediately.
Ensure safe execution of turret installations, removals, and changeovers to prevent injury or equipment damage.
Safely handle tooling components, including proper use of PPE (Personal Protective Equipment) such as gloves, safety glasses, and protective footwear.
Support lockout/tagout (LOTO) procedures when working on equipment as required.
Follow all site safety policies, OSHA guidelines, and GMP safety requirements always.
Requires standing, lifting, and interaction with production equipment

Compliance & GMP Adherence

Operate in a GMP-regulated environment, following 21 CFR Part 111.
Ensure compliance with SOPs, documentation practices, and cleaning validation requirements.
Support audits by maintaining accurate tooling records.

Tooling Management & Inventory Tracking System Management

Maintain, inspect, clean, and store tableting and encapsulation tooling including punches, dies, and turret components.

Ensure tooling meets all specifications, tolerances, and quality requirements prior to use.
Coordinate tooling refurbishment, replacement, and vendor services as needed.
Manage tooling inventory through a structured tooling tracking spreadsheet/system.
Maintain detailed records of tooling lifecycles, including usage history, wear trends, and maintenance intervals.
Ensure accuracy for operational decision-making and audit readiness.

Tooling Performance, Troubleshooting & Optimization

Monitor tooling wear patterns and performance trends to maximize tooling life and maintain product quality standards.
Analyze tooling-related production issues including sticking, picking, capping, lamination, weight variation, encapsulation defects, and other tooling-related quality concerns.
Partner with Production, Quality, and Maintenance teams to identify root causes and implement corrective actions for tooling-related issues.
Evaluate tooling performance and recommend replacement, refurbishment, repair, or modification based on operational requirements and wear analysis.
Verify tooling condition, setup, and readiness prior to production startup to ensure compliance with product specifications and quality requirements.
Assist operators and production personnel during startup and changeover activities to ensure equipment is operating efficiently and producing quality products.
Track tooling performance metrics including tooling lifespan, refurbishment costs, downtime events, and replacement frequency.
Recommend tooling improvements and process enhancements that improve operational efficiency, product quality, and manufacturing throughput.

Communication & Production Coordination

Use Redzone to communicate real-time updates on changeovers, downtime, and tooling status.
Log issues, escalating problems, and document production impacts within Redzone.
Communicate professionally via work email with Production, Quality, Maintenance, and the Dosing Manager regarding priorities, risks, and tooling availability.
Support shift-to-shift communication to ensure continuity.

Changeover Support (High Urgency Operations)

Execute and support urgent and scheduled turret changeovers for tablet presses and encapsulation equipment.
Minimize downtime by ensuring tooling readiness and organization.
Respond quickly to production needs in a fast-paced, high-demand environment.
Fast-paced production setting with time-sensitive demands.

Job Requirements:

High school diploma or GED required; technical certification or associate degree preferred.
2–5 years of experience in nutraceutical, or GMP-regulated manufacturing.
Hands-on experience with tablet press and/or encapsulation tooling strongly preferred.
Ability to lift and handle tooling components (up to ~50 lbs).
Standing, bending, and manual dexterity required for equipment setup and maintenance.
Mechanical aptitude and troubleshooting ability.

Technical Skills - Strong understanding of:

Tablet press turrets, punches, and dies
Encapsulation tooling systems
Tool wear patterns and maintenance practices
Experience working with GMP environments and CFR 111 compliance.
Proficiency in Excel or similar systems for tracking tooling inventory and usage.

Learn more about this Employer on their Career Site

Dosing Tooling Specialist