Project Management Medical Device

Luis E. Pérez Esquilín

Tel. 787-***-**** // ad5ctc@r.postjobfree.com // Lic. # 12291 EIT

Professional Vision

A proven leader in the Pharmaceutical and Fuel industries. Hard worker and goal oriented, seeking a challenging opportunity to manage and lead teams and projects where my advanced skills, education, training, and many years of experience can be fully utilized.

Career Highlights and Accomplishments

30+ years of Engineering and Management cross functional experience in manufacturing, most of them in the Pharmaceutical and Medical Device industries. Working for the last few years as an independent consultant on CQV Project Management for construction and startup of new facilities, including tech transfer for products and processes. Developed the Validation Master Plan and all related documents templates and Traceability Matrix. Also ensure the facility design is in compliance following the regulations and Good Engineering Practices, based on rooms classification and people and material flow. Managed projects activities; cost control, change orders, RFP, and track project expenditure to be align to capital plan for the current year and projections for the end of project. Developed and implemented the Quality System for all operational areas with their Policies and Procedures, including Validation and Maintenance programs.

Rounded professional experience mostly on Project Management and Capital Projects, Maintenance and Reliability, and Validation and Qualification, which includes Process Validation and Equipment, Utilities, Facilities and Software Qualification (IQ/OQ/PQ), User Requirements Specification (URS) and Functional Specifications (FS), Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Also, vast experience in Regulatory Compliance, Remediation Plan and related activities, Documentation Revision and Approval, Quality Control & Quality Assurance (QA), and Change Control.

Managed Capital Projects for capacity expansion by selecting and acquiring Manufacturing and Utilities equipment for Sterile process areas. This includes the construction of Aseptic areas, with ISO 5 (Class 100) Clean Rooms involving the HEPA filters layout and airflow profiles. Also, the Qualification of Equipment and Validation of the Area and Process.

Broad experience in Facilities Maintenance management. Implemented maintenance programs with Preventive Maintenance (PM), Predictive Maintenance (PdM) and computer management system, developing the system Work Orders and Job Plans.

Extensive knowledge in Pharmaceutical process equipment, such as; Process Tanks, Pumps, Rotating Equipment, VFDs, Lyophilizers, Sterile area Filling machines for bottles and vials, Packaging Equipment; Labeling machines, Testing and Inspection Systems, Cartoners and Case packers. Utilities; AHU, Chillers, Cooling Towers, Autoclaves, Water Purification Systems (WFI), Clean Steam Generators, Air Compressors, Refrigerators, Freezers, Incubators, Cell & Gene technology and Facilities Maintenance.

Managed Technical Team for the development and implementation of Remediation Plan for CQV, Preventive Maintenance, Calibration Program, and Laboratory Equipment. Including Legacy Plan for equipment or procedures that required more time to be in compliance.

Reviewed and approved CQV documents; Facilities, Utilities, Equipment Qualification, Thermal Mappings, Sterilization and Cleaning cycles, Clean Room Validation with HEPA Filters profiles, and Trial Runs packages during the site’s startup.

Experience in Injection Molding Qualification. Molds acceptance process with manufacturer, injection molding process qualification and approval at the supplier’s site (FAT).

Broad experience with fully automated and computerized systems; HMI, PLC, I/Os, Sensors, Interlocks, BMS

Green Belt Certified.

Extensive supervision experience and excellent interpersonal and communication skills.

Trainer, mentor, and coach to my team of professionals.

Professional Experience

November 2022 – Present

August 2022 – October 2022

February 2021 – August 2022

January 2018 – February 2021

January 2020 – April 2020

June 2019 – November 2019

October 2017 – December 2017

January 2017 – October 2017

July 2016 – December 2016

July 2015 – June 2016

Previous

Professional Experience

June 2012 - June 2015

April 2006 – May 2012

March 2005 – March 2006

July 2002 – March 2005

July 1999 – July 2002

July 1997 – June 1999

February 1994 – June 1997

October 1991 – February 1994

Projects Worked as an Independent Consultant

Regeneron Pharmaceuticals (Albany, New York)

Worked on the manufacturing equipment Qualification activities as part of the tech transfer from the actual CMO to the new Regeneron packaging operation building. Equipment and system include Syringes and Vials Filling Machines, Cartoners, Case Packers, Palletizers, and Serialization System. Also, auto-injection devices assembly machines.

Krystal Biotech (Pittsburgh, PA)

Project Manager for CQV activities for the startup of the new Cell & Gene Tech facilities at Pittsburgh, PA. Led group to follow the Commissioning/Qualification plan and documentation completion for equipment procedures (SOP), and Job Plans.

Biosciences Corp/ OcyonBio (Toa Baja / Aguadilla, PR)

Project Manager for CQV strategy for the startup of the CytoImmune and OcyonBio new Cell & Gene Tech facilities at Toa Baja and Aquadilla, Puerto Rico. Developed validation plan/schedule and related documentation: Validation Master Plan, validation program procedures (SOP), templates for URS, FS, Commissioning, IQ, OQ and PQ for equipment, utilities, and facilities.

Established site Quality Systems, including the development of Policies and Procedures.

Recruited, mentored, and lead the team of professionals working in the CQV, Quality and SOP areas.

Worked with the facility design and modifications to be in compliance and aligned with the current Pharmaceutical Industry guidelines and practices.

Completed transition from Mechanical Completion to site startup by fulfilling the CQV plan with all the stages on time: suppliers coordination, equipment installation, safe startup, FAT, SAT, Commissioning, Qualification, Thermal Mapping and Final Reports with document closing after resolutions for all deviations.

Sr. Director for Maintenance, Metrology and Facilities at OcyonBio facilities at Aguadilla, developed the site Maintenance Department strategy. Established the site services operation with contracting services for facility cleaning, pest control, and waste disposal. Also implemented the EHS program.

Noven Pharmaceuticals (Miami, FL)

Project Manager for Facility Qualification (IQ/OQ/PQ): Qualification of new packaging room facilities, Air Changes, Differential Pressure, and Temperature and Humidity parameters validation. The Air Handling Unit (AHU) and the Compressed Air points of use were qualified as well. (Project Leader)

Utilities Qualification (IQ/OQ): Compressed Air Generation System with one variable speed Compressor and one fixed speed Compressor, two Dryers, one wet and one dry Tanks, and sets of particle, coalescence and carbon Filters. (Project Leader)

Prepared and executed Protocols for Manufacturing Equipment Qualification, such as Pouching Machines, Checkweighters, Coaters, Drying Oven and Thermal Oxidizer. Also performed Laboratory and Quality Equipment Qualification.

Develop the Facilities Qualification live cycle procedures, including the URS, FS and IOQP templates. (Project Leader)

Developed the Test Method Validation (TMV) for the new pouching machine inspection stations.

Dynamix International Group (Ft. Lauderdale, FL)

Project Manager for food industry supplier facility. Define and improve distribution center process and operation. Raw Materials and Consumables receiving and storage, product labeling and packaging, shipping of final product and Invoicing. Also developed process for Customer claims and Orders (PO) processing.

Regeneron Pharmaceuticals (Albany, New York)

Facility Qualification (IQ/OQ/PQ): Qualification of new sampling room facilities, including the Air Handling Unit (AHU); Air Changes, Differential Pressure, Temperature and Humidity parameters, doors interlocks, HEPA filters, rooms illumination.

Process Utilities Qualification: Performed IQ/OQ to CIP Skids and associated tanks.

Baxter Healthcare (Jayuya, PR)

New Clean Room Validation: Commissioning and Qualification of AHU. Air Changes, Differential Pressure, and Temperature and Humidity parameters validation. Manufacturing Equipment Qualification.

Prepared Protocols for product rework based on defects and pre-defined conditions of packaging, serialization and product identification.

Updated three Validation Master Records (VMR) for 2017. Performed data gathering for leading quality indicators, key operational parameters, exceptions, maintenance history, FMEA, CAPA and customer’s complaints.

Amgen (Juncos, PR)

Project Manager for Tech Transfer project for the introduction of two new products to the site. Manage the related Change Controls including Implementation Plan.

Review and approve new processes and equipment documentation, drawings and P&IDs.

Project Plan execution, coordination of scheduled activities, prepare and lead project meetings, prepare weekly status report.

Baxter Healthcare (Jayuya, PR)

Developed the Remediation Plan for the Preventive Maintenance program. Performed a gap analysis of the Facilities and Utilities (RO, WFI, AHUs) and Manufacturing equipment (Steam Sterilizers, Autoclaves, Pumps) based on the Corporate Standards and Regulatory guidelines.

Revised Preventive Maintenances Work Orders instructions and frequencies based on manufacturer’s recommendations, site maintenance data, and my professional experience.

Prepare final reports and approval documents as deliverables to the Management.

Puma Caribe (Virgin Islands)

Project Manager for the construction, refurbish and branding for three new fuel facilities; two service stations and one staging and storage site.

Prepare project plan and followed up on project activities with project team members. Lead project meetings, and prepared agendas and meeting minutes.

Managed project site activities; worked directly with Contractors and government agencies to adhere with the project schedule.

BP (British Petroleum)

Tank Farm Manager

Manage the fuel tank farm at the San Juan International Airport. in charge of tank farm equipment and vehicles fleet operation and maintenance, and Capital Projects for tanks and pumps acquisition and refurbish. Also, Responsible for the fuel receiving, storage and delivery, safeguarding the highest product quality in compliance with the industry and government regulations, and company standards.

Responsible for the regulatory agencies and customer’s audits and inspections, including response reports (FAA, ATA 103, API 653, Fire Department and airlines). Also, responsible for the Safety and Environmental programs.

Perform Suppliers audits to confirm their compliance with standards and regulations. Worked with Suppliers to identify root cause and establish corrective actions for any deviation or defect found.

Responsible for the site Process Safety Management (PSM) program, including documentation and certifications for the vessels and related components. Also, in charge of the regulatory and corporate audits.

Prepare year end reports for the completed projects, audits findings and equipment failures.

Eli Lilly Pharmaceuticals

Maintenance Team Leader

Reviewed and Approved Equipment selection and Qualification documents as part of the expansion project. The documents were prepared by Contractors but based on the Company requirements. Managed project Change Control activities.

Responsible for the calibration and metrology program for manufacturing, utilities and laboratory instrumentation. Also in charge of mechanical equipment maintenance. Manage contract services budget and personnel to ensure compliance with business plans and production schedules.

Lead maintenance predictive/corrective/preventive programs for Manufacturing, Laboratories, Warehouse, Tank Farm and Utilities. Evaluate and recommend improvement methods using Engineering concepts to maximize equipment utilization.

Prepare and provide metrics in order to present overall department service execution and recommend solutions for future maintenance programs to be implemented.

Performed equipment related investigations and change control documentation as needed to ensure process effectiveness and meet business goals.

Accountable for the Process Safety Program. Include equipment verification, documentation, training, PSM observation investigations, corrective and preventive actions.

Develop an EHS certification program to improve line breaking and lock out processes before maintenance intervention to prevent safety or environmental incidents.

Wyeth Pharmaceuticals

Reliability Engineering Manager

Lead Reliability Team to develop the site strategy and implement the program to monitor and improve manufacturing and utilities equipment reliability. Using Reliability Centered Maintenance (RCM) tools, including Risk and Failure Mode Analysis.

Utilized RCM for analyzing the functions and potential failures of plant equipment, and improving maintenance activities by reviewing maintenance frequencies, job plans, spare parts availability, etc.

Wyeth Pharmaceuticals

Sustainable Compliance Manager

Lead a team of professionals for the implementation of a Remediation Plan based on the Quality Corporate Standards by redesigning Validation, Maintenance, Calibration and Laboratory Equipment programs, including revising operational procedures, training and execution practices. All accomplished by aligning the corporate Quality System Elements and the FDA Regulations to the different processes.

The Validation Quality System Element was the more complex, in which we developed more than ten different procedures to comprehend the different Validation activities in our site, such as Aseptic areas cleaning methods, Equipment (Sterilization and Lyophilizing cycles) among others.

For the Maintenance Quality System Element we designed a structure of documents and Procedures which simplified the system that was in place. This approach earned the acceptance of other company sites and was recognized as a best practice.

Reviewed and Approved the new expansion buildings Validation and Startup packages with the documentation of the Trail Runs, Equipment Qualification, Autoclaves and Lyophilizers cycles, Clean Room Validation with HEPA Filters profiles and Laboratories Equipment Validation.

In this particular role a direct coaching approach was required to provide guidance and assistance to the personnel developing the documentation. Also, Reviewed and Approved all documents packages, together with the owners of the different areas.

Baxter Fenwal Division

Principal Engineer

In charge of Manufacturing equipment maintenance, supervising engineers and technicians. Responsibilities included operation and maintenance of an E-Beam sterilization equipment.

Responsible for Process and User Requirements document generation, Factory and Site Acceptance Test, equipment validation; Installation, Operational, Performance Qualification and Software Validation. Also perform Injection Molding molds qualification and approvals.

Document revision for new equipment specifications, User Requirements Specification, Functional Requirements, Factory Acceptance Test, and Validation package.

Developed the Equipment and Software Validation procedures including the data collection forms and design requirements.

Lead and participated in Suppliers audits for plastic components. Troubleshoot and performed failure analysis together with Supplier, then define the process parameters and perform mold validation. The continue Supplier process monitoring.

Allergan America, Inc.

Process Engineer

In charge of Manufacturing equipment maintenance, including Compounding, Filling, Packaging and Utilities. Supervised technicians and mechanics, and offered technical support for trouble shooting, training, etc.

Led projects for Aseptic areas, Clean Rooms and Packaging areas. Also, acquired the Filling, Testing and Packaging equipment. And managed all project steps; from capital expense request to User Requirements Specification, Factory Acceptance Test, Site Acceptance Test, IQ/OQ/PQ and process validation.

Also, worked on Engineering Changes and Corrective and Preventive Actions to improve manufacturing efficiency and performance.

In charge of the manufacturing module on the implementation and validation for SAP System.

Chemetronics Caribe, Inc.

Quality Control and Engineering Supervisor

Develop the Quality System for the ISO 9000 implementation. Coordinate between departments for document control and training. Also, in charge of manufacturing equipment and plant facilities maintenance.

Performed Supplier audits, review and approve parts and process changes. Maintain a strong relationship with Suppliers, which helped in improve communication and problem solving response.

Economic Development Adm.

Metal Industry Specialist And North District Coordinator

Worked as Consultant Engineer for support on engineering drawings and specifications. Evaluate, identify and recommended solutions for problems found in the metal industry related to Department of Defense procurements.

Education and Certifications

B.S. Degree in Mechanical Engineering

University of Puerto Rico Mayagüez Campus 1991

Project Management Certification – 2013 - BP

Lean Six Sigma Green Belt Certified – 2011 - Lilly University

Train the Trainer Certified – 2010

Pump Alignment – 2008

Six Sigma Certified – 2000 - Baxter Quality Institute

Certify Quality Engineer (CQE) Academia - 1994 - The American Society for Quality Control

Information Systems

Knowledge

Valgenesis, Maximo, BMRAM, MP2, Data Stream, ProCal, SAP, Trackwise, GxPharma, Word, Excel, Power Point, MS Project, AutoCAD, Visio.

Contact this candidate