Summary
Overview
Work History
Education
Skills
Timeline
Hi, I’m

Luis Lugo Crespo

Hatillo,Puerto Rico

Summary

Utility operator and manufacturing +6 in the pharmaceutical industry and biotechnology industry. Knowledge in the operation and solution of equipment. Experience in GxP regulated environment and aseptic environment. Prepare microbiology equipment, samples, data form and labels for testing. Experience in microbiology testing such as pH testing, environmental sampling with MAS-100, Climex, viable, non-viable and passive sampling testing and water sampling. Responsible, organized, punctual, dynamic, quality oriented and team member to perform multiple tasks simultaneously with minimal supervision. Excellent interpersonal relationship and communication. Perceptive Utility Operator with six years of experience overseeing functionality of vital building utilities with varying system configurations. Mechanically fluent troubleshooter of problems with complex HVAC, plumbing and electrical systems. Versatile in installation of heating, air conditioning and plumbing systems for large facilities with acute knowledge of latest building utility technology.

Overview

6
years of professional experience

Work History

Bristol Myer Squibb Biotechnology

Manufacturing Tecnichian Parenteral
01.2023 - Current

Job overview

  • Enhanced safety procedures by conducting regular inspections of utility systems and reporting any concerns or issues.
  • Collaborated with other departments to coordinate utility usage, minimizing disruptions to plant operations.
  • Maintained compliance with industry regulations through careful documentation of utility system readings and adjustments made.
  • Collaborated with cross-functional teams to expedite the drug development process, resulting in faster time to market.
  • Aseptic techniques and drug product filling
  • Collaboration with media fill
  • Maintained compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines.
  • Documentation reviewer
  • Preparation and mixing and filtration for further process needs
  • Preparation of buffer and mixing
  • Write and review standards operating procedures, formulation, cleaning and batch records
  • Operation of general production equipment such as Autoclave, Analytical scale, part washer
  • Parental Manufacturing Virtuosi- Aseptic technique Certification.
  • Improved product quality, implementing rigorous testing procedures and quality control measures.
  • Collaborated with cross-functional teams to expedite the drug development process, resulting in faster time to market.

Swanson Health Vitamins

Manufacturing Operator
01.2022 - 01.2023

Job overview

  • Blending process follow GMP
  • Cleaning the machines
  • Bring the products to the manufacturing area
  • Fill the information that are needed to CMS program
  • I am forklift certificated
  • Knowledge CMS program and Mozart
  • Knowledge in solve mechanical problems and trouble shootings in the machines
  • I have trained people in manufacturing area for the whole process of blending, documentation and encapsulate and sanitization
  • Solve troubleshooting of the equipment
  • Performs equipment set-up and changeover.

Boehringer Ingelheim Pharmaceutical

Utility Operator
01.2021 - 01.2022

Job overview

  • Operate equipment following safety practices and operating guidelines
  • Monitor and document the performance of the equipment following the practices of the GMP documents
  • Water treatment plant
  • Raining water sampling
  • Troubleshooting to identify and correct deviations
  • Sampling of water test for micro lab tests and documentation
  • Sanitize equipment as necessary and established
  • Document the rounds of wwt, ipure system, chillers, towers as established following GMP practices
  • Monitor and control environmental regulatory parameters, pH in the basin area
  • Monitor and change flow and pH graphs
  • Open and close prase
  • Inject acid or caustic to control pH in the TA-9010 and TA-9011 tanks
  • Realization of pH meter verification
  • Operate chillers and towers
  • Emptying of the dam
  • Inspection of trenches
  • Verification of graphics in warehouses
  • Checking and status of the fire system
  • Load acid and caustic following safety regulations.
  • Maintained safe working conditions by adhering to safety protocols and proper handling of hazardous materials.
  • Maintained accurate records of plant operations, including daily logs, maintenance reports, and regulatory documentation.
  • Adhered to EPA and OSHA regulations.
  • Enhanced water treatment efficiency by optimizing plant operations and conducting routine maintenance.
  • Disinfected water with chemicals such as ammonia and chlorine in exact concentrations.
  • Performed routine maintenance and repairs on water-treatment plant equipment to reduce downtime.
  • Monitored water quality and adjusted chemical dosages to meet regulatory standards.
  • Collected water samples to test alkalinity, hardness, and residual levels.
  • Prepared reports and documentation related to plant operations.
  • Optimized chemical usage by conducting regular analyses and adjusting treatment protocols as needed.
  • Monitored water production and tested water samples to evaluate quality and safety.
  • Utilized SCADA systems to monitor and control plant operations.
  • Operated equipment such as front-end loaders, forklifts, and slakers regularly.
  • Ensured compliance with safety regulations by conducting regular inspections and addressing potential hazards promptly.

Boehringer Ingelheim Pharmaceutical

Manufacturing Technician
01.2018 - 01.2021

Job overview

  • Environmental testing
  • Packaging operator
  • Operate packaging equipment
  • Responsible for performing product inspection for defect classification and product sampling
  • Sanitization of the areas
  • Perform equipment cleaning and disassembly as necessary
  • Document inspection results and lot classification in batch record
  • Document cleaning of equipment and areas in the corresponding cleaning records as indicated in the procedure
  • Configure product information on the team's HMIs
  • Component and product transfer to the production area
  • Validation in F4 packaging area and Nexgard Manufacturing area thermoformer.
  • Manufacturing area F6 and F4
  • Major and minor cleaning including sanitization of the area by procedure
  • Knowledge and execution of the grinding, mixing and drying area process
  • Product sampling and inspection
  • Cleaning with CIP solution, LPH according to the procedure
  • Preparation of solutions
  • Knowledge in SAP
  • Assembly of parts, assembly and disassembly of the equipment and necessary assistance.
  • Troubleshot equipment issues, minimizing downtime and keeping production on track to meet deadlines.
  • Maintained a safe work environment by enforcing safety protocols and conducting routine inspections.
  • Made sure that products were produced on time and are of good quality.
  • Increased overall productivity by training new technicians and providing ongoing support to team members.
  • Assembled and tested parts and components to meet safety and performance standards.
  • Recorded and documented all maintenance activities in accordance with company policies and procedures.
  • Performed routine equipment calibration to maintain consistent product quality and adherence to specifications.
  • Documented all manufacturing activities, maintaining accurate records for reporting purposes and quality assurance audits.
  • Improved production efficiency by implementing standardized procedures and streamlining workflow.
  • Calibrated machines to maintain required productivity levels and adherence to quality standards.

Education

Universidad Catolica De Puerto Rico

Associate Degree in Science from Optical Science
01.2017

University Overview

Skills

  • Good Manufacturing Practices
  • Documentation Review
  • Equipment Calibration
  • Hazardous waste disposal
  • Chemical Inventory Management
  • SCADA System Management
  • Time Management Aptitude
  • Performance metrics analysis
  • Quality Control Processes and Inspection
  • Quality Assurance Abilities
  • OSHA Standards and Compliance Familiarity
  • Teamwork and Collaboration
  • Time Management
  • Critical Thinking
  • Excellent computer skills

Timeline

Manufacturing Tecnichian Parenteral
Bristol Myer Squibb Biotechnology
01.2023 - Current
Manufacturing Operator
Swanson Health Vitamins
01.2022 - 01.2023
Utility Operator
Boehringer Ingelheim Pharmaceutical
01.2021 - 01.2022
Manufacturing Technician
Boehringer Ingelheim Pharmaceutical
01.2018 - 01.2021
Universidad Catolica De Puerto Rico
Associate Degree in Science from Optical Science
Luis Lugo Crespo