• Support the successful execution of the organization's strategic project portfolios and programs. • Support monitoring and reporting on the progress of schedules, financial accuracy, and benefits of the portfolios and program components. • Enforce a standardized approach to project management, providing guidance and supporting our Gurabo site portfolios and project initiatives aligned with the Site Master Plan and Site Strategy.• Report to the Site Project Management Office (PMO): - Use project management and Project Portfolio Management (PPM) tools to promote a project management culture. - As a servant leader, ensure the Site Project Management Office (PMO) aligns with J&J standards and steward the organization's change management, agility, and accountability agents.

Operations Leader: Spravato®/: Remicade® Fill & Finish, Combination Product Assembling & Serialized Packaging Operations•Leads Spravato Sterile/Non-Sterile fill & finish, combination product and serialized packaging areas. Also, commercial packaging lines with over 81 launches SKU’s for US, Canada and ROW (Rest of The Word).•Leads Remicade sterile product Optical Inspection bulk packaging lines.•Leads the production scheduling to assure manufacturing process shift leaders and supervisors coordinate with area planners and quality personnel to organized and comply with project and commercial commitments.•Participates actively in the readiness/preparation of area budget and manage company funds and assets.•Support productivity and efficiencies initiative by following performance management at Tier 1, 2 & 3.•Support Spravato technology transfer activities, equipment, qualification, process validation, troubleshooting developmental batches, DEA compliance, by providing the necessary resources, documentation review/approval and process expertise.

Remicade® Parenteral Facility, Fill & Finish, Lyophilization & Bulk Packaging:• Directed the creation of new SOPs, systems and batch records during start-up phase.• Provide technical and operational support to all validation exercise.• Coordinate production planning during validations, project schedule adherence, cost reduction, and budget controls of the parenteral operations including: formulation, filling, sealing, lyophilization, components and equipment preparation and the aseptic area.• Ensured that all departments and its personnel followed company policies, and pharmaceutical regulatory standards.• Managed a facility with $4 million in work-in-progress and $60 million in state of the art Biopharmaceutical Fill and Finish process equipment and its facility.• Support the review and approval of investigations related to Manufacturing Area deviations, including the implementation of preventive and corrective actions.

Responsible for the organization and coordination of the daily activities in the Lyophilization area. On charge of maintenance and production areas. Maintains the area of accountability according to cGMP, company policies and pharmaceutical standards. Prepare, review and approve the batch records documentation. Generate SOP’s, Master Batch Records or other job related instructional aids. Perform investigations of process deviations if required. Prepare and maintain training programs for employees according to the company polices.

Responsible for the organization and coordination of the daily activities in the Equipment Preparation and Formulation Departments (Aseptic / Non Aseptic Areas) by physical presence and according to cGMP, company policies and pharmaceutical standards. Prepare and review batch records documentation. Generate SOP’s, Master Batch Records or other job related instructional aids. Investigations of process deviations using SAP CAPA and SAP Commitment. Prepare and maintain training programs for employees. Coordinate validation on new automated process and areas start up. Coordinate manufacturing team to manufacture and perform test on new automated facilities controlled by Process Control System (PCS), Human Machine Interface (HMI), closed formulation vessels, CIP, SIP, etc. Perform the proper coordination for prevent maintenance, calibration, projects and validations, in order to prevent loss time and maintain the schedule compliance. Train new supervisor and group leaders. Coordinate and maintain manufacturing material and components inventory.

Perform Trouble shooting in order to solve technical problems with a low impact on the manufacturing process. Collaborate preparing event report investigations of process deviations. Prepare and maintain training programs for employees. Coordinate manufacturing team to performed test on automated formulation and equipment preparation facilities: PCS with HMI, close formulation vessels, CIP, SIP, autoclaves, ultrasonic washers, cabinet washer and stopper processors like HUBER and ICOS machine. (Acting Supervisor).

Responsible for the organization and coordination of the Formulation and preparation area Aseptic / Non Aseptic daily activities. Maintains area accountability according to cGMP, company policies and pharmaceutical standards. Prepare and review batch records documentation. Generate SOP’s, Master Batch Records or other job related instructional aids. Help investigations of process deviations. Prepare and maintain training programs for employees. Coordinate manufacturing team to performed test on automated formulation and equipment preparation facilities: PCS with HMI, close formulation vessels, CIP, SIP, autoclaves, ultrasonic washers, cabinet washer and stopper processors like HUBER and ICOS machine. (Acting Supervisor).

Responsible for the calibration of GMP critical and No-Critical instruments on aseptic / non-aseptic core; like: RTD’s, scales, valves, autoclaves, ovens, stopper treatment machines, load cell etc. Create calibration methodologies and job guides. Perform Trouble shooting in order to solve technical problems with a low impact on the manufacturing process.

Responsible for the formulation, weighting and filtration process of lyophilized products like Piperacillin and ZOSYN. Perform hydrophobic and hydrophilic filter integrities tests using Paltronic Flow Star machines. Weight, formulate and filtrate aseptic process simulations. Operate autoclaves (Fedegari), ovens (ICOS), stopper treatment processors (ICOS, HUBER). Prepare different filling equipments and components; formulate disinfectant agents like Clorox, LPHse, Vesphene and Exspor. Unload stopper treatment machines in accordance with aseptic techniques. Perform trouble shootings and repair any GMP equipment.