Jorge T. Aponte De Los Ríos

**** ************* *****

Hilliard, Ohio 43026

614-***-****

adv2dj@r.postjobfree.com

Objectives

Pharmaceutical industry facilitator to support the different objectives of Manufacturing, Engineering, Validation, Technical and Technology processes, Optimization (lean Manufacture), Safety, environmental requirements and Quality with compliance. Lead, manage, support and educate the members of the different work groups to carry out the required activities as a team, ensuring to help the staff on the skills and competences development, maintaining the focus to achieve the objectives and delivery deadlines of the different projects and/or requirements. Support the organization development in the industrial branch and offer the knowledge of my experience in the Pharmaceutical industry and technology.

Experiences

2015 – Present, Associate Director Validation Services, Boehringer Ingelheim and transition to Hikma Pharmaceutical, Columbus Ohio

As Validation Services AD, my goal is to maintain and support the manufacturing, cleaning, laboratory, engineering and business areas, ensuring compliance with validation, compliance, quality, safety and environmental standards and regulations. Responsible for the approval and completion of validation documents that meet regulatory guidelines and business requirements for equipment, utilities, facilities, and process control systems. Responsible for controlling risks associated with validation regulatory requirements and leading the Validation Services Department in the effective interpretation and deployment of regulatory requirements through proper documentation, including planning, risk analysis, recovery strategies testing, periodic review and validation assessments. This position provides both short- and long-term strategic direction and ensures alignment with site goals for computerized systems validation, cleaning validation, process validation, and equipment qualification/validation. Responsible for supporting site initiatives such as zero defects and behavior-based compliance, providing launch resources, conducting business reviews to drive site goals, and departmental communication. This position is responsible for a cost center budget in excess of three million dollars. This position also has responsibility for developing future leaders within the organization and supporting the compliance services organization. This position helps uphold the concept of the Dynamic Compliance Model and provides value propositions and guidance to local, BIRI, RLI, R&D, AD and global initiatives, International Information Systems Validation and Compliance Working Group, quality initiatives and compliance. During my activities I managed the risk assessment to improve the change control management process and create different forms of management including change control, repair and emergency change control. In this way, as a single organization, we improve the way we manage work in the facilities and improve our procedures to document properly. One of the biggest achievements was the improvement of communication and recognition between the validation services and the operations departments (manufacturing, engineering, IT and laboratories). Global procedures were created for the computer validation process and training was given to the entire organization globally. This connectivity improves the implementation of new activities with global compliance as part of the implementation.

2014 – 2015, Associate Director Technical Flow, Boehringer Ingelheim, Columbus Ohio

As AD Technical Flow my objective was to maintain and support the areas of manufacturing operations ensuring that manufacturing requirements are met and maintaining compliance with safety, environmental and quality standards. To achieve these objectives in my department, my personal and group approach was important, since support was given to all packaging operations for liquids, combo products, solid (capsules, tablets, and powder), solid and liquid manufacturing areas, and a fully contained operation (HCO)" total of 258 products. This was achieved with a cross-functional engineering group of 10 engineers. My goal was to bring downtime processes to 20% (80% uptime) (by measuring uptime and the time the equipment is affected by equipment problems) and maintain daily operational support by addressing and following up on abnormal events and maintaining open and honest communication between optimizers and manufacturing staff (feedback from coaches and on AD performance optimizers) Strengthen ties to support groups and maintain communication with them to ensure results are up to date In line with manufacturing requirements (feedback from maintenance personnel, process quality and optimizers, trainers, planning, release, validation, cleanup, and change management). Capital cost project management and submission assurance cover all requirements to support operational requirements (information from Capital Engineering Group). Ensure compliance with change control requirements when making changes within the operation. (Information provided by the Change Management department). Support the launch of new products and strengthen the preparation activities and operational requirements of teams (launch group and the quality group and Change Management). Management of the optimizer coverage for the operation, training and support necessary to change the culture of security and compliance. Ensure a culture of continuous improvement by actively supporting the CIA process and setting high standards of training in Lean and Six Sigma behaviors. Strengthen the change management process in operations to ensure proper planning, documentation, evaluation and execution requirements are in place. Develop future plans to improve critical operations and create standardized manufacturing systems. Create an improvement plan for computer systems and definition of when the equipment becomes obsolete. Strengthen the deviation management system by seeking new and better ways to maintain system documentation and compliance. Improve the management system during maintenance or work on the equipment, improving the safety and compliance of the operation.

2009 – 2014, Manufacturing Associate Director F-2 Operations, Merck Sharp & Dohme, Barceloneta Puerto Rico

Manage the manufacturing operation of two different processes (solids and solvent charges, distillations, methylation, hydrogenation, crystallization, isolation of solids, centrifugation, filtration, drying and grinding) during the last 5 years of the facility, keeping the operation and personnel focused on business needs and customer demand, in addition to preparing the facility for closing and decommissioning. Lead and supervise 5 exempt and 38 to 70 hourly employees. The manufacturing operation was managed maintaining the implementation requirements of the SAS Optimization projects. All facility decommissioning requirements were handled (IQ's documentation, procedures, calibrations, preventive maintenance, and cleaning with a process to maintain the facility in future conditions). Administrative management of all staff for the performance evaluation and objectives. Lead Qualification execution activities to support the demonstration of the new process. Lead as manufacturing representative in evaluation projects. Oversee manufacturing operation to maintain the compliance with GMP, Q7A, Environmental, Safety, SOX, OSHA. Identify, manage and support all manufacturing program requirements to meet the EA and profit plan. Manage changes to documents as required by the operation to ensure proper implementation. Maintain the training of all personnel in the proper way to carry out the operation, ensuring that the procedures are followed and that they remain in compliance with the training profile.

2007-2008, Associate Director Technical Services and Operations on the F-2 operations and optimizations projects support, Merck Sharp & Dohme pharmaceutical, Barceloneta, Puerto Rico

Manage a group of support to the manufacturing activity and projects. Manage and lead a Brine project to optimize and change a single fluid system for manufacturing operations. Support the implementation of Toyota methodology tactical and strategy operation. Implement the same waste reduction project in the manufacturing process with strategies of lean manufacturing; using elimination of waste (muda), value stream mapping, Standardization and six sigma evaluation was implemented in other process. Participate in 2 of 3 trainings for by a black belt “six sigma specialist”. Manage the investigation of atypical and complains were received in the site for the API manufacturing operations. Manage new projects for the Environmental site to the waste treatment and the solvent reuse. Manage evolution of ideas to improve or reduce cycle time in the process. Manage and Support all the implemented system in the manufacturing process to continue improvement.

2006-2007, Manufacture Associate Director in F-3 and Leader of the optimization project for SAS process, Merck Sharp & Dohme pharmaceutical, Barceloneta, Puerto Rico

Manage the operation during the last year of manufacturing of F-3 and prepare the installation for the closed out. Lead and supervise 5 exempts and 15 hourlies. Manage a project to improve the optimize operation of SAS in F-2. Improve the manufacture activities to reduce the cycle time, standardization of the operations, improve the SOP’s and Batch sheets and finally create the entire process map in operation and information. Eliminate all the different waste in the operation. The project was successfully implemented and all the expectations were meet. In this project was needed a total of 5 exempts and 4 hourly. Improvements of operation of the reduction in manpower of the 50 % and improve the manufacturing time cycle in 25 %. Participate in continues improvement group and in the value stream mapping for F-2.

2000-2006, Manufacture Associate Director of F-2 Operations, Merck Sharp & Dohme pharmaceutical, Barceloneta, Puerto Rico

Manage and lead the manufacturing operation during the demonstration in F-2 of 8 different products, those ones came directly from MRL. Manage and manufacture lead the expansion of F-2 for the SAS project for a total cost of 240 M dollars. Manage the profit plan, budget and EA for the F-2 operation. Participate in the certification for Barceloneta in A for MRP II. Lead and manage a total of 24 exempts and 70 indirect hourly personnel, in the operation was managed the PCR’s implementation, modification, shipments, schedule of manufacture, and all the new division strategies. Participate in tactical rings and tactical and strategically meeting for the definition of the business for Barceloneta and Puerto Rico operations. Support and manage the manufacture operation during demonstration of ENALAPRIL to support divisional strategies of inventories and supplies. All the demonstration exceeds the expectations on yield and soft cost and maintains on favorable cost in the profit plan. Manage the schedule generation with the planning department and define the resources needed. Lead all the regulatory teams, as GMP, Safety and Environmental. Support all the requirements for the regulatory requirements, as HAZOP’s, GMP audits, Environmental audits, financial audits and housekeeping initiatives. Participate in the implementation of the new strategy of Merck to improve the business. Prepare the facilities for the new organization system IPT structure. Facilitate and support all the training requirements for the personnel. Support and participate in the generation of the value stream mapping for the F-2 process and began to the lean manufacture strategy and the pull production technique with the measurement of buckets. Working with the initial indicators for the visual control charts in the F-2 manufacturing process, lots status, process time, cycle time, lots per week, on schedule. Generation of all require metrics and indicator for the personnel and operation.

1996-2000, Project Manager, Merck Sharp & Dohme pharmaceutical, Barceloneta, Puerto Rico

Participate in the project of a new product as EPRINEX, in charge of the cleaning and process validation activities. Design the process water system in a remediation plan for the site due to a warning letter. Manage, support and participate in the construction, operation and validation for the process water system for the operation of F-2, F-3, F-4, F-6 and distribution system for the site. Implement the use of UV, and ozone system, hot and cold system, PW-100, 500, endotoxic reduction. The project includes the upgrade of the DI water system in the utilities area and the addition of new technology. During those activities were generated 75 IQ’s, 9 OQ’s and 4 PQ’s, 3 Master Validation Plans. Support DCS project for F-2 in the PROVOX system for the implementation of expansion and the 2000 efforts. Those activities include the generation and execution of DDS, FAT, IQ’s, and OQ’s. In addition, manage the implementation of the critical modules on the expansion project and new product implementation at F-2. Installation and qualification of the BOLZ-SUMIX Conical dryers and blenders, and Vacuum filters COGEIM. In addition I was the technological champion for SUMIX and COGEIM at Merck PR operations and participate on the committee of Merck technology. During the new product introduction, I was the main contact to support and manage the Process Qualification of all the products that use the SUMIX and COGEIM technology to assure we did the proper implementation.

1992-1996, Process Engineer in F-3, Merck Sharp & Dohme pharmaceutical, Barceloneta, Puerto Rico

Manage all the equipment modifications and PCR’s for the process. Support the operation in trouble shouting in the Hydrogenation, catalyst kill step, crystallization, distillation, filtration, purification, and centrifugation and drying process. Manage all the subdivision of the material to worldwide and first contact to the planning department. Manage all the “MIMS” system transactions to control and distribute the inventories. Participate and support during the MRP certification class A for Barceloneta operations. Manage the monthly inventories and report the EA to the manufacturing manager. Manage the HAZOPS studies for all the operation and implement all the recommendations to the operation, batch sheets, and SOP’s. Manage the campaign of Human Production Participate (Human product) and represent the manufacturing area important projects for the Veterinary API manufacture change in the filtration with the use sparkler filter, 10X expansion project to increase the capacity from 7 up to 19 batches per week as a record and the continues distillation process to reduce the impurities generated in that step. Manage the improvement to the cleaning strategy and validate the cleaning steps and the manufacture process. Manage the system administrator position during three years and implement the remediation plan for the operation with all require procedures. Participate and lead the groups in the factory for the safety, environmental and GMP. In addition, lead all the regulation implementation requirements in the plant. Generate the Process specific training and maintains update for every year.

1990-1992 Utilities Supervisor, Merck Sharp & Dohme pharmaceutical, Barceloneta, Puerto Rico

Supervise a total of 5 hourly operators and manage the utilities operation (cooling towers, chillers (chilled water and Brine), compressors (air, nitrogen), solid and solvent incinerator, waters (fire water, potable water, process water, DI water), Steam generation with boilers and a turbine with a cogeneration system and the electric distribution system. Manage and operates the waste treatment system for the entire site. Manage and coordinate the maintenance of the unit and supervise the entire shout down activities including the equipment’s and the electric distribution system. Mange the performance evaluation and objectives for the hourly personnel. Performed the sampling during the storm water every 300 day or when heavy rain occurred, execute the interlocks testing for all the air emissions units (solvent and solid incinerator, boilers) every 30 days to compliance with the air permit. Perform the mass balance of the substances in the clean air act and reported to the environmental department. Manage as the Maintenance head during the non-operational hours, after 4:00 pm up to 8:00 am and during the weekends. Due to this I was manage the trouble shooting and all the permit requirements to do the mechanic, electrical and instrumentational works on the facility. In additional be the lead of the emergency brigade and responds team.

Professional skills

SUPERVISION

Development of 12 Engineers to different positions in Puerto Rico and the USA and 6 employees per hour to exempts

Handling of up to 200 employees per hour and 34 exempts

Handling of evaluations of objectives of the direct personnel and indirect reporting

Handling of disciplinary actions and awards due to the executions

ADMINISTRATION

Handling of budget for the manufacture operation up to 150 Million dollars

Handling of budget for expansion projects up to 560 Million dollars

Handling of Chemistry, Bulk manufacture and pharmaceutical Operations

Definition and creation of the objectives for the all departments and the working area

Manage all the Compliance and Quality requirements on the pharmaceutical Business

Experience to manage audit with regulatory agencies and/or vendors/Clients

ENGINEER

Development of design for Process waters systems and the operations to controlled

Development of design for manufacturing plant site and handling of the facilities for engineering operation

Development of design of DCS and PROVOX control system for automatic manufacturing operation

Manage of operations, problem solution and unit operations maintenance for all utilities unit operation (Cooling Towers, solid and solvent incinerators, air compressors, chillers for chilled water and brine system)

Develop and manage manufacture and pharmaceutical operation with different technologies

Manage and evaluate alternatives by the process of six sigma

TACTIC

Development of plans for development of employees

Development and implementation of master plans for continuous improvement on manufacture operations with 5 years plan

Improvement of facilities and expansions of operations for improve and increase manufacture capacities

Strategic

Definition of development plans for the operations in vision of 5 and 10 years plan

Generation and implementation of financial plans (budget, profit plans and EA’s) and efficiencies to optimize the operations and the maintenance with revisions of SOP’s with different tools

Handling with state and federal authorities plans to reduction of costs and manage with the universities plans to improve the education as needs require by the industries

Studies

1984-1990 University of Puerto Rico recinto of Mayaguez (School of Agriculture and Mechanical art of Mayaguez), Mayaguez, Puerto Rico

Chemical Engineering

Specialty in Mathematics, chemistry and kinetics of Reaction

References

The references are available upon request.

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