Summary
Overview
Work History
Education
Skills
Certification
Languages
Work Availability
Timeline
Generic

Gregorio E. Frías Fermín

Manatí,Puerto Rico

Summary

Proactive and goal-oriented professional, experienced in developing and implementing improvement initiatives, ensuring regulatory compliance, and optimizing resource use. Capable of motivating and influencing others to execute at their best and get the extra mile, this being a by-product of the excellence in people skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth. Known for adaptability, analytical thinking, effective communication and project oversight.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Sustainability/Environmental Manager – EHS Department

Bacardi Corporation PR
04.2023 - Current
  • Ensure compliance with local, state, and federal environmental regulations
  • Monitor changes in environmental legislation and assess implications for the organization
  • Organize and carry out meetings with local and federal regulatory agencies
  • Develop the audit readiness strategy
  • Develop, implement and improve environmental management policies and procedures
  • Establish and maintain an environmental management system (EMS) consistent with regulatory standards
  • Identify, develop, and oversee sustainability programs aimed at reducing the organization's environmental footprint
  • Promote innovative practices to enhance resource efficiency and waste management
  • Lead the sustainability projects to achieve the organization target at regional and global
  • Design KPIs to ensure the continues improvement
  • Conduct training sessions for employees on environmental policies, procedures, and best practices
  • Raise awareness about environmental issues and foster a culture of sustainability within the organization
  • Collect and analyze environmental data to assess performance and identify areas for improvement
  • Prepare reports for management and regulatory agencies on environmental performance, goals, and outcomes
  • Collaborate with internal and external stakeholders to address environmental concerns and improve practices
  • Respond to inquiries from regulatory agencies, community organizations, and the public regarding environmental impacts
  • Oversee environmental projects, ensuring they are completed on time and within budget
  • Lead environmental audits and assessments to identify compliance gaps and areas for improvement

Process Engineer – Distillery Department

Bacardi Corporation PR
04.2016 - 03.2023
  • Define operational strategies to ensure production plan is achieved
  • Develop and analyze process performance and quality trending charts to ensure compliance avoiding product defects and regulatory deviations
  • Evaluate the operation of Waste Water Treatment Plant to ensure optimal performance and regulatory compliance
  • Analyze the performance of anaerobic digesters, bioreactors and sanitary plant to identify tendencies and define action plan
  • Evaluate process performance and provide recommendations to improve results
  • Monitor the day to day operation and provide technical support to ensure a lean process: maximizing utilities consumption (cooling water, compressed air, process water, steam), reducing energy related costs, maximize resources; mitigate process failure (downtime)
  • Develop and lead the implementation of cost reduction projects
  • Daily support to Global Manufacturing activities to meet the goals established by the corporation
  • Accountable for the equipment maintenance, setup & troubleshooting
  • Accountable for updating and maintaining manufacturing process aligned with current practices
  • Accountable for continuous improvement projects and financial analysis
  • Lead implementation of new distillation system from commissioning to qualification activities
  • Accountable for technical support and process performance monitoring for the Used Water Treatment Plant, Reverse Osmosis Water Treatment and Distillation Waste Treatment (Biogas Fuel Treatment)
  • Responsible for the startup of the biological treatment reactor
  • Responsible for equipment and process qualifications/Validation
  • Support or lead product and process introduction activities from planning to implementation phase
  • Responsible to provide necessary information to maintain appropriate spare parts inventory
  • Investigate non-conforming product events to identify cause, implement controls to eliminate potential failure modes, and assess corrective actions and controls efficacy
  • Ensure compliance with all procedures and all applicable regulatory agency requirements
  • Responsible for the technical development of operators and supervisors
  • Lead the Bacardi Career Development Program for undergraduate students
  • Identified as undergraduate students mentor
  • Responsible for identifying process efficiency and cost reduction projects to be executed, develop project charter and job description for students, establish the project deliverables and timelines

Senior Validation Specialist

Bristol Myers Squibb
09.2015 - 04.2016
  • Company Overview: Manatí P.R
  • Site, Aerotek
  • Design validation protocols to perform installation, operational and performance qualification studies for equipment/systems servicing the parenteral operations
  • Define qualification strategies based on risk based approach, establish validation requirement, develop sampling plans, and technical justifications
  • Develop sterilization cycles for new loads as part of autoclave qualification, SIP systems (tanks / filler machine) qualifications
  • Develop strategies for optimization of sterilization processes
  • Support equipment revalidation program
  • Generate protocol deviations, gap assessments, implement corrective actions based on qualification results
  • Support Regulatory documents updates
  • Perform temperature mapping and qualification of cold storage equipment and Lyophilizers
  • Serve as liaison between BMS and service providers for new cold storage refrigerated trailers, coordinate maintenance and service support
  • Prepared final reports to close the equipment/process qualification phase
  • Coordinate and lead qualification projects execution
  • Revise procedures, issue work orders and Kaye Validator set up and calibration
  • Support closure of CAPAs
  • Manatí P.R
  • Site, Aerotek

Validation Specialist: New Product Transfer

Abbvie
09.2014 - 08.2015
  • Company Overview: Barceloneta P.R
  • ABL Site, MDI Engineers
  • Develop Validation Master Plan in support to new product introduction
  • Develop protocols and execute equipment qualification and cleaning validation activities in support to new product introduction
  • Qualification of sterilization cycles for tanks, filter housings, transfer lines, equipment parts
  • Issuance of validation change request
  • Develop strategies to reduce qualification activities following a Risk Based approach
  • Coordinate execution activities with multiple supporting areas (manufacturing, engineering, quality, etc.)
  • Barceloneta P.R
  • ABL Site, MDI Engineers

Process Engineer: Cleaning Validation Project

Merck & Co., Inc
02.2014 - 08.2014
  • Company Overview: Barceloneta P.R
  • Site, ALPROEM
  • Lead cleaning validation project execution and implementation
  • Develop Process Validation Master Plan
  • Generate protocols and summary report for cleaning validation execution
  • Generate batch records to support the cleaning validation/execution activities
  • Train operators in protocol and strategy prior to cleaning execution
  • Generate and follow up process change request in Trackwise
  • Perform field evaluation of process flow to establish cleaning strategy
  • Barceloneta P.R
  • Site, ALPROEM

Validation Engineer: EBRs Update Project

Abbvie
06.2013 - 02.2014
  • Company Overview: Barceloneta P.R
  • Site, Select Source Int
  • Agency
  • Validation of Manufacturing Electronic Batch Record recipes
  • Develop Change Impact Assessment and discuss strategy with Change Review Board
  • Generate and route documentation for medium and high impact changes to Electronic Batch Records for multiple products
  • Ensure documentation required is completed prior to protocol execution
  • Barceloneta P.R
  • Site, Select Source Int
  • Agency

Process Engineer: New Manufacturing Process Implementation

Merck & Co., Inc
02.2012 - 05.2013
  • Company Overview: Barceloneta P.R
  • Site, ACT-1 Agency
  • Lead successful project plan execution
  • Coordinate meetings to follow up Pre-Execution activities completion
  • Create spread sheet to track the activities execution
  • Generate and follow up process change request in Trackwise
  • Initiate change controls for process improvements, cost reduction and equipment replacement
  • Update Bill of Materials requirements
  • Perform field evaluation of process parameters, equipment, materials, product flow and recipes to support process changes
  • Perform Gap analysis of local procedure against regulatory and internal guidelines to ensure the API bulk manufacturing process complies with quality and regulatory expectations
  • Update Standard Operational Procedure to be in alignment with regulatory guidance
  • Update Site Validation Master Plan to include validation activities to be executed within the year and provide summary of the activities completed
  • Participate in Risk Assessment project to identify the potential failures of the process and implement mitigation activities prior to execution of validation runs
  • Generate supporting documents (protocols, assessment and technical memorandums) for manufacturing process changes
  • Generate batch records to support the cleaning and process validation activities
  • Train operators in validation documents prior to execution
  • Barceloneta P.R
  • Site, ACT-1 Agency

Project Coordinator: Product Transfer Project

Pfizer
01.2011 - 02.2012
  • Company Overview: Vega Baja P.R
  • Site, Weil Group, Inc
  • Coordination of product transfer activities (from manufacturing to packaging process)
  • Liaison between sending and receiving sites for materials procurement
  • Ensure packaging Bill of Material are created and approved for new transferred products
  • Ensure required materials and components are provided by suppliers included in the approved vendor list
  • Ensure materials and components are qualified and approved by the Quality Unit
  • Coordinate testing of materials and components with Analytical laboratories
  • Ensure documentation required is completed prior to execution of Stability runs
  • Coordinate samples shipment in support to Stability runs
  • Ensure successful project plan execution
  • Provide alternatives to solve issues and ensure schedule attainment
  • Lead project meetings and project plan maintenance
  • Identify roadblocks and potential impact to schedule
  • Generate printed packaging components request and track items approval
  • Vega Baja P.R
  • Site, Weil Group, Inc

Lean Six Sigma Trainee

Merck Sharp & Dohme Química
10.2010 - 01.2011
  • Company Overview: Barceloneta P.R
  • Site, Lean Six Sigma Trainee
  • Operational Excellence, Lean Six Sigma Green Belt Certification
  • Trained in Yellow Belt & Green Belt
  • Downtime reduction project associated to secondary packaging line
  • Process mapping, identify areas of improvement, root cause analysis
  • Generated reports using Minitab Software
  • Set Up Status Report Meetings
  • Barceloneta P.R
  • Site, Lean Six Sigma Trainee

Education

Engineer in Training Certificate (EIT) -

Master in Management and Strategic Leadership (MBA) -

Universidad Del Este SUAGM
07.2011

BS - Chemical Engineering, Environmental Engineering Certificate

University of Puerto Rico
05.2009

Skills

  • Office 365
  • Project
  • MatLab
  • MathCAD
  • SAP
  • LIMS
  • Visual Basic
  • AutoCad
  • Hensad
  • CapCost
  • Aspen
  • Visio
  • Minitab
  • TEAMS
  • Leader
  • Excellent communication skills
  • Project Manager Training
  • Kaizen Leader
  • Validation Specialist
  • OSHA safety seminar
  • Bilingual
  • Environmental permitting
  • Hazardous materials management
  • Waste management
  • Environmental policy development
  • Air quality monitoring

Certification

  • Lean Six Sigma Yellow Belt Certified
  • CAPA and Root Cause Certification
  • Certified Firefighter
  • Certified Environmental Manager

Languages

Spanish
Native or Bilingual
English
Full Professional

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Sustainability/Environmental Manager – EHS Department

Bacardi Corporation PR
04.2023 - Current

Process Engineer – Distillery Department

Bacardi Corporation PR
04.2016 - 03.2023

Senior Validation Specialist

Bristol Myers Squibb
09.2015 - 04.2016

Validation Specialist: New Product Transfer

Abbvie
09.2014 - 08.2015

Process Engineer: Cleaning Validation Project

Merck & Co., Inc
02.2014 - 08.2014

Validation Engineer: EBRs Update Project

Abbvie
06.2013 - 02.2014

Process Engineer: New Manufacturing Process Implementation

Merck & Co., Inc
02.2012 - 05.2013

Project Coordinator: Product Transfer Project

Pfizer
01.2011 - 02.2012

Lean Six Sigma Trainee

Merck Sharp & Dohme Química
10.2010 - 01.2011

Master in Management and Strategic Leadership (MBA) -

Universidad Del Este SUAGM

BS - Chemical Engineering, Environmental Engineering Certificate

University of Puerto Rico

Engineer in Training Certificate (EIT) -

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Gregorio E. Frías Fermín