Jose Irizarry

• Lead spare parts inventory optimization to reduce storeroom value, optimize operational efficiency, and improve equipment availability across diverse manufacturing facilities
• Work with procurement and suppliers to analyze storeroom operations and usage patterns, achieve proper spare parts stocking levels, and identify supplier management improvement opportunities
• Developed the company's Qlik Sense Spare Parts dashboard that includes cataloging and identification, transaction details, actual lead times, excess stock, ledger summary, and storeroom value to facilitate data-driven decision-making approaches.
• Develop, revise, and manage spare parts-related control processes and documentation, equipment maintenance systems, including maintenance planning cycle, and tooling expensing management
• Facilitate workshops and conducted one-on-one training to educate team members; created $27MM in excess inventory.
• Conduct comprehensive program evaluations, identifying areas for improvement and recommending actionable solutions.
• Identify program obstacles and communicate possible impacts to the team.
• Meet with project stakeholders on a regular basis to assess progress and make adjustments.
• Address and resolve technical, financial, and operational concerns with team members and directors.

• Developed the following equipment maintenance program/tools with their workflows and SOPs (when applicable) and their implementation strategy: Equipment Coaching Program, Oven & Auxiliary Equipment Maintenance Scorecards, Maintenance Day Debrief form, Maintenance Planning Coordinator's Curriculum Map, JD Edwards (JDE) Power User Training for Maintenance Planning Coordinators, P1 Notification Program, Yellow Pages; listing plants' salaried team and active suppliers by equipment.
• Managed cross-functional teams for successful completion of complex projects, resulting in increased productivity.
• Provided expert guidance on best practices, ensuring consistent adherence to industry standards across all manufacturing processes.
• Developed comprehensive training programs for staff, enhancing their skillsets and improving overall performance.
• Collaborated with other departments to identify opportunities for synergy, ultimately leading to reduced costs and improved performance.
• Implemented preventative maintenance plans for equipment, reducing unplanned downtime due to breakdowns or malfunctions significantly.

• Successfully led the implementation of the maintenance standard project (plant level)
• Managed storeroom inventory for washer and wastewater-related materials and ODMs
• Implemented the 5S program in the flammable/explosion-proof room and ODM stores
• Coordinated maintenance schedules to keep plant running at optimal levels.
• Enhanced safety protocols for overall workforce protection and reduced accidents on the job.
• Provided employee training programs focused on skill development, promoting a knowledgeable workforce capable of handling diverse tasks within the plant environment.
• Performed line checks to assess quality of materials, parts and final products.
• Ensured DOT 49 CFR 172.702 and 49 CFR 172.704 compliance; environmental regulations on using, dispensing, or handling hazardous and non-hazardous materials and wastes.

Key Projects

T.H.E.M. Packaging, a Clorox CMO – Marlton, NJ

Role: Food Safety Auditor representing The Clorox Company

• Created and executed a development plan in support of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and food safety practices
• Revised all food safety SOPs to comply with all Safety Food Quality (SFQ) and client requirements
• Developed GMP, GDP, and customized 5S Methodology training modules for packaging staff

Integra Life Sciences – Plainsboro, NJ

Role: Validation Specialist supporting MFG and PACK operations

• Created Installation, Operational, and Performance Qualification (IOPQ) protocols for the new medical transfer facility equipment compliance with FDA Code of Federal Regulations Title 21
• Executed Building Management Systems (BMS) and Facility Monitoring System (FMS) Installation and Operational Qualification (IOQ) protocols
• Executed IOQ protocol for the Packaging Machine and Cut & Inspect Machine at 109 Medical Transfer

The Clorox Company – Pleasanton, CA

Role: Food Safety Auditor-Technical Writer (Research & Development Division)

• Created the SOPs for the new foods pilot plant facility at the Clorox Pleasanton Campus in compliance with the FDA Code of Federal Regulations Title 21, HACCP, and the Food Safety Modernization Act

Genentech, a member of Roche Group – Hillsboro, OR

Role: Packaging Compliance Engineer - Manufacturing Science & Technology (MSAT)

• Global consolidation of bio-pharma packaging design, configuration, and supply chain; creating component designs, material selection, and preparing procurement documentation – developed specifications, reviewed submission, and managed the approval process
• Worked closely with pharmaceutical development, regulatory, quality assurance, and supply chain to oversee and meet all packaging technical and operation activities, including but not limited to regulatory submissions, engineering studies, line qualification, storage, and distribution/shipping testing, to ensure supply of commercial and clinical products
• Author of documents such as Spec, artwork, drawing, URS, Concept Design Freezes, Device Master Records (DMRs), Qualification Project Plans (QPPs), and Shipping Qualification Protocols
• Subject Matter Expert (SME) pre-approver for new products' quality and engineering documents containing product identifiers (serialization) consisting of NDC, serial number, lot number, and expiration date

Janssen Supply Chain, Pharmaceutical Companies of Johnson & Johnson – Vacaville, CA

Role: Packaging & Process Engineer / Project Division / Engineering Administration

• Global artwork change controls (CCs) administrator – partnered with Baxter, Novartis, and Boehringer Ingelheim for UK, Germany, Scandinavia, France, Denmark, and US. Slashed CC approval timelines
• Rolled out global harmonization strategy – selected and managed suppliers and tracked raw materials' performance to ensure compliance with packaging technical and operation requirements, including but not limited to regulatory requirement submissions, engineering studies, and qualifications.
• Supported shipping qualification protocol execution; served as SME to WestPak Testing Laboratory
• Executed raw materials qualification to comply with contract-manufacturing organization agreements
• Adopted lean supply chain practices for materials, artwork, and configuration acceptance criteria related to primary packaging to meet customer and operations component integrity requirements.

• Developed innovative solutions to complex technical problems, resulting in improved system functionality and user experience
• Maintained open lines of communication between management and staff, fostering trust and transparency throughout the organization
• Collaborated with cross-functional teams to achieve production goals and optimize workflow.
• Worked closely with quality, engineering, production control, sterilization, training, and warehouse leaders to ensure comprehensive operations support for the overall business strategy
• Supported nonconforming product handling and disposition assessments and managed all records
• Co-developed a lean project that resulted in volume increases of over $8MM annually
• Awarded with the CooperVision Continuous Improvement Achievement for slashing start-up and ramp-up goals of new manufacturing technology