Chemical Engineering Quality Engineer Certified Quality Auditor

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October 08, 2022

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I am a Chemical Engineer holding a Bachelor of Science Degree in Chemical Engineering. Have strong technical validation, and project management knowledge, as well as organizational, influential, collaborative, and interpersonal skills. Experienced in recommending modifications of quality standard procedures to improve manufacturing processes and reduce company expenses due to non-conformances events. Effective working with cross functional teams including project managers and subject matter experts to complete the validation engineering responsibilities within established schedule, budget, and goals for the launch of a new product commercialization in the US. Adept with collaborating across departments to manage, lead, and execute projects, while committed to professional standards and meeting deadlines.

Areas of Experience

-Project Management and Organizational skills

-Leadership

-Automated/controlled systems CSV knowledge

-Utilities Validation: Heat Exchangers, Air Handling Units (AHUs) / Heating and Ventilating Air-Conditioning Systems (HVACs), Oil Free-Air (OFA), Nitrogen (N2), Water Stills, Compressors

-Equipment Validation: Unscramblers, Fillers, Laser Coders, Filtecs, Neckbanders, Labelers, Cartoners, Case Packers, Form Fill and Seal Machine, Checkweighers, Conveyors,

-Knowledge in GMPs, GDPs, GLPs, GEPs

-Internal, External and Regulatory Audit experience

-Manufacturing and Packaging industry experience

-Biotechnology, Pharmaceutical, Health Care and Medical Devices

-Six Sigma Tools for process improvements

-Interpersonal / Facilitation Skills

-Self-starter and works with minimum supervision

-Self-oriented with project goals

-Effective working in teams or individually

Professional Experience

FUJIFILM Diosynth Biotechnologies, College Station, TX

Quality Assurance Specialist, Auditor Apr 2021 to Sep 2022

Sr Compliance Specialist – QA (Consultant, VEQTOR) Oct 2020 to Apr 2021

Responsible for supporting client audits, regulatory inspections, conducting internal and supplier assurance audits.

oFor Regulatory Inspections and Client Audits: supported a total of nine (9) audits in 2021 and five (5) in Q4 2021. Additionally, for Q1 and Q2 2022, there were around ten to twelve (10-12) client audits back-to-back every other week in which I continue leading the backroom and escorting the auditors during the site tours. Preparation activities and having the pre-requests ready for the auditors was crucial for the success of a prompt response to the auditor’s requests.

oFor Internal Audits: successfully led four (4) and supported nine (9) audits. Also, per upper management and business needs, I supported three departmental manufacturing audits in one week. Working hours were shifted to witness the manufacturing activities. Audit finished on time. The purpose was to ensure the company is prepared for Regulatory Inspections and client audits and to mitigate the risk to Critical observations.

oFor Supplier Audit: supported two out-of-town audits for the Warehouse department

Review the performance and/or level of conformity with internal procedures and compliance with regulatory requirements/guidelines. Also identify any issues which may need correction prior to becoming agency/client observations.

Leadership: Work collaboratively with site management to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.

Compliance Delivery: Support to the organization in conducting internal and supplier audits and hosting audits/inspections.

New Business Growth: Work with Quality management to implement quality systems that will enable cGMP manufacturing of preclinical to commercial products.

Compliance: Support the external and internal Audit Programs to be in an acceptable state of compliance. Responsible for audit preparations, conducting internal audits, assisting client audits with site documentation gathering, leading “war room” when required. Support Global Supplier Assurance - work with the global team to participate and represent Texas Site in supporting joint audits.

Hologic, San Diego, CA Sep 2019 to Jun 2020

Quality Engineer II

Ensured validations were addressed according to the QMS, Validation Plan, GMP, ISO and current applicable regulations and guidelines.

Supported internal, external and Regulatory Audit

Supported Validations, sustaining activities, Process Transfer Reviews, Expansion, Revalidation and Remediation Projects - performed Change Order (CO) and NCE/QSI assessments, manages and/or participates on projects including legacy product manufacturing projects to complete validation activities in support of sustaining activities.

Supported Manufacturing Engineering – Supplier & raw materials qualifications - responsible for the implementation of changes and that could potentially have an impact and affect the process or the product’s form, fit and function by the introduction of new, existing or modified parts in the process.

Generated, reviewed, approved, and managed GxP system lifecycle documentation in ValGenesis and Agile: pFMEAs, testing protocols (IQ/OQ/PQ), Validation Reports, SOPs, Risk Assessments, Validation Deviations and Qualification Summary Reports.

Collaborated in the compilation of information to be prepared in the backstage and presented to auditors, ensured personnel were fully trained in procedures, equipment and systems, ensured procedures and practices were up to date and in compliance with current regulations and established guidelines.

Abbott Aerotek– San Diego, CA Dec 2018 to Sep 2019

Validation Engineer III (Consultant)

Ensured validations were addressed according to the QMS, Validation Plan, GMP, ISO and current applicable regulations and guidelines.

Provided support for process validation including new product development and legacy product manufacturing.

Vital Therapies Incorporated– San Diego, CA Mar 2018 to Sep 2018

Senior Validation Engineer

Coordinated validation activities with team support from Validation, Process Development, Manufacturing, Facilities & Engineering, Quality, third parties, and other groups on validation projects.

Generated, reviewed, approved, and managed GxP system lifecycle documentation in Master Control: URS, FRS, testing protocols (IQ/OQ/PQ), Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Validation Deviations and Qualification Summary Reports.

Reviewed protocols or generated/executed commissioning, qualification for 21 CFR Part 11 systems for QC Lab and Regulatory Affairs departments.

Generated validation deviation and supported investigation, troubleshooting and corrective actions to close out discrepancies and deviations.

Reviewed final reports and executions for equipment/ system requalification, periodic reviews, and media fill (Aseptic Process Validation).

Conducted equipment and system risk assessments and impact assessments.

Revised validation documents ensuring compliance with QA, cGMP requirements and industry standards.

Allergan PSC Biotech– Waco, TX Oct 2016 to Mar 2018

Sr. Validation Engineer (Consultant)

Participated in and conducted all types of Facilities, Equipment, Process, and other validation.

Led and coordinated the validation efforts regarding the installation, Operation and Maintenance of the Heating, Ventilating and Air-Conditioning (HVAC) Systems and other utilities systems to provide efficient and effective operational and environmental conditions in the manufacturing area (cleanrooms).

Lead and participated in the improvements of HVAC and related system operations and computerized management systems (i.e. FMS, BMS) that required validation testing.

Drafted Commissioning protocols and led execution in conjunction with technicians and external resources. Some of the testing included:

Installation Verification – PLC Modules, HVAC Filters, Motors, VFDS, Dampers Return/Exhaust/Mixing, Heating and Cooling Coils, Pressure Range, Temperature range, Materials of constructions and slopes of the piping for hot and chilled water, labeling, etc.

Operational/ Functional Verification – Screen navigation verification, environmental conditions (servers work stations and humidity levels), loss of utility, VFD speed, room temperature and humidity (% recovery), Differential Pressure, HEPA Filter Integrity Test, Air Flow Changes and Changes Per Hour, Smoke Test (Air Flow Pattern), Viable Monitoring and Particulate Count PLC Jumper Switch configuration, HVAC Air Balance

Computer-related Equipment and Software testing – Backup verification

Coordinated with Facilities Manager, SMEs and Engineers the validation activities related to new installation, assessments or changes to the existing system made after a component malfunction. That required the parallel coordination with planning and production departments of the timeframes for external contractors to show onsite and perform the services with the assistance of the facilities technicians.

Oversighted the performance of service contractors during shutdown activities, system interventions (i.e component replacement or repairs, troubleshoot and alarm testing), installation of new systems and ensured safety work practices and conditions (i.e confined spaces, working at heights).

Generated LOTO (Lockout/Tagout) Procedures and convey training to personnel involved in the operation and maintenance of the Facilities systems.

Compiled Turnover packages of new systems (Operational Manuals, warranty and manufacturer’s contact information, procedures to follow during installation and maintenance, testing performed during validation, manufacturer’s calibration certificates of critical components i.e. thermostats).

Wrote and executed validation protocols, such as URSs, FATs, System Level Risk Assessments (SLRAs), Component Level Risk Assessments (CLRAs), Technical Assessments (TAs), Commissioning, IQ/OQs, etc.

Utilized competent technical writing skills.

Maintained current knowledge and implementation of cGMP, cGLP, cGCP, cGDP.

Participated in and conducted validation of laboratory equipment as part of the Microbiology Laboratory Expansion Project.

Created, reviewed, and/or modified Standard Operating Procedures (SOP).

Managed and delivered client satisfaction.

Established and maintained positive working partnerships with clients.

Collaborated with Project/Account Managers to develop expanded project opportunities.

Performed additional tasks related to project(s) scope.

Collaborated with support, training and guidance to PSC co-workers and client personnel.

Haemonetics, Inc. – Union, SC Oct 2015 to Jun 2016

Sr. Validation Engineer (Consultant)

Plasma Solution Expansion Project Support – assisted in the expansion of the site to increase production capacity for the sale of solutions and grow sales for Plasma customers. For this, Utilities and Process Equipment were acquired providing validation support for activities consisting of the development and execution of URS, FAT, SAT, Commissioning, IOQ, etc. along with project management skills.

Reverse Osmosis, Multiple Effect Still, Clean Steam, Mixing Tanks, Water for Injection (WFI) Tanks, Fillers, Overwrap Machines, Sterilizer among other equipment and systems were acquired and validated for the new and current process.

Assisted and coordinated Management and Vendors meetings.

Effectively communicated, both technical and non-technical topics with all levels of the organization, verbally and in writing.

Imparted proper training to personnel on how to adequately use new systems and how to adopt and exercise new manufacturing practices inside clean rooms.

Ensure personnel were fully trained and records for trainings were available in the electronic systems.

Actavis Laboratories, Inc. – Salt Lake City, UT Apr 2015 to Sep 2015

Sr. Validation Engineer (Consultant)

Coordinated the execution of validation protocols for packaging line integrated equipment, including scheduling, communication, coordination of execution between Manufacturing Engineers, Technology, and operating groups to meet project goals.

Effectively communicated, both technical and non-technical topics with all levels of the organization, verbally and in writing.

Validation support and Risk Assessment activities for: Capper Machine, Delta Thin Pouching Machine, Filler, Transfer Pump, Check Weigher, Re-torquer, Induction Sealer and Bottle Cleaner.

GlaxoSmithKline (GSK) CPM Panama, LLC. – Panama City, Republic of Panama

Sr. Validation Engineer (Consultant) Sep 2014 to Oct 2014

Worked simultaneously on three (3) projects: Dust Collector Replacement, new AHUs additions to existing HVAC Systems, Improvements to Manufacturing Rooms; providing validation support to Senior Engineers and Project Managers during shutdown activities for nineteen (19) consecutive days in a fast-paced environment.

Lead and participated in the improvements of HVAC and related system operations and computerized management systems (i.e. FMS, BMS) that required validation testing.

Executed testing in conjunction with technicians and external resources. Some of the testing included: Installation Verification – Differential Pressure, HEPA Filter Integrity Test, Air Flow Changes and Changes Per Hour, Smoke Test (Air Flow Pattern), Viable Monitoring and Particulate Count PLC Jumper Switch configuration, HVAC Air Balance, Temperature range, Materials of constructions and slopes of the piping for hot and chilled water, labeling, etc., Loss of utility, VFD speed, room temperature and humidity (% recovery).

Performed IOPQ, Final Reports and supporting documentation for mentioned projects.

Bausch+Lomb EB Validation Services, Inc – Greenville, SC

Validation Engineer (Consultant)

Oct 2014 to Dec 2014

Jun 2013 to Sep 2014

May-Jun 2013

Performed larger validation / remediation activities (IOPQs, Final Reports and other documentation) for Filling Lines and Utilities, this last one includes: Hot Purified Water Systems, Clean Steam Systems, Heating, Ventilating and Air Conditioning (HVAC) Systems, Compressed Air and Point of Use Heat Exchangers.

Generated LOTO (Lockout/Tagout) Procedures and convey training to personnel involved in the operation and maintenance of the Facilities systems.

Ensured personnel were fully trained in procedures, equipment and systems, ensured procedures and practices were up to date and in compliance with current regulations and established guidelines.

Planned and prioritized the project work load to ensure that validation activities ran smoothly and project deadlines were met; this includes coordinating and performing validation activities within or without production schedule, tracking and reporting the progress of activities, managing project strategies to anticipate or remove obstacles to validation activities.

Corporate Offices, Caguas, PR - Revised and approved SOPs to comply with cGMPs, standards and regulatory requirements.

Validation & Engineering Group, Inc Apr 2013 -May 2013 / Apr 2012-2013

Validation Engineer / Specialist (Consultant)

Olay Cayey, PR - Assisted with cleaning (CIPs) and sanitization (SIPs) validation executions and documentation, as well as, equipment qualification and process validation.

Novartis Humacao, PR - Developed and executed new facilities and equipment Validation and Documentation. Experience included development of IOQs/PQs, User Requirement Specifications (URS), Technical Assessments, Equipment Validation Re-evaluation to comply with regulatory requirements, and Functional Requirements Specifications (FRS).

Provided support in the execution of CSV tests for PLC, HMI, and software applications.

Amgen Manufacturing Limited Kelly Services – Juncos, PR Dec 2010 to Apr 2012

Validation Engineer (Consultant)

Re-evaluated SOPs for better understanding and execution regarding manufacturing processes. This included interaction with personnel from manufacturing areas and quality department, working with documents through an electronic system and applying knowledge of chemistry and engineering principles to improve daily operations that complies with cGMPs requirements.

Provided recommendations for modifications within quality standard procedures to improve manufacturing processes and to reduce company expenses due to non-conformances events.

Pfizer Manpower – Caguas, PR Jul 2010 to Dec 2010

Technical Writer and Facilitator

Provided support to analysts (QA and QO Technical Specialists) in batch records compilation and filing.

Assisted QA in the backstage using electronic systems to gather the requested information for external audits.

Assisted the QA Department with strategies to reduce time in the batch records release process.

Danosa Caribbean Inc. – Bayamón, PR Mar 2010 to Jul 2010

Chemical Engineering Professional Services

Liaison between engineers and operators to include interacting and interviewing operators to develop process improvement recommendations to evaluate and implement future modifications in the development on polymers, asphalt, and other products for the production of waterproof membranes.

Provided support to engineers working in R&D of new formulas for products, QC/QA inspections, technical writing, and laboratory support.

Unilever Co. Caribbean Temporary Services (CTS) – Las Piedras, PR Jun 2009 to Feb 2010

Group Training Leader, Machine Operator

Coordinated daily task group to meet the production goal for Manufacturing Production areas.

Provided trainings of the machine operation and process logistic to new hire employees.

Skills identification between group members, to assign positions and delegate tasks in production lines.

Reported feedback on production details to supervisor on duty.

Education / Memberships

ASQ Certified Quality Auditor

ASQ – World Headquarters Issued Jun 2022 -Expires Jun 2026

Credential ID 54015523

Member of the American Society for Quality (ASQ)

Science in Chemical Engineering

Bachelor of Science in Chemical Engineering

UNIVERSITY OF PUERTO RICO - MAYAGUEZ, PR

Certificate in Industrial Biotechnology

UNIVERSITY OF PUERTO RICO - MAYAGUEZ, PR

Continuous Education / Seminars

Certified Quality Auditor Certification Self-Preparation

Project Management Trainings

cGMPs; FMEAs, Lean Six Sigma tools for improving Process Quality, Speed and Complexity (DMAIC, 5-Whys, Pareto Analysis, Fish Bone Diagrams, etc.)

Workshops in Lyophilization and Cleaning Validation Processes

Introduction to Computerized Validation Systems presentation/workshop

Wastewater Treatments and Water Purification Certification

Process/Piping and Instrumentation Diagram (P&IDs) workshop

Better Process Control School as prescribed by the USFDA

Languages

Spanish - Native language

English - Fluent in both reading/writing and spoken

Italian - Intermediate understanding/reading and basic conversational

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