Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Hector Hernandez

Round Rock

Summary

Conscientious Validation Engineer with 20+ years overseeing development on safe, effective products. Specializes in Equipment validation, Software validation and Medical devices systems. Dedicated to maximizing safety and efficacy of deliverables to encourage customer loyalty and drive revenue growth.

Talented managerial skills with expert team leadership, planning and organizational skills built during successful career.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Validation Engineer Sterilization (Contractor)

Flex
10.2023 - Current
  • Lead/Support validation lifecycle, develop validation protocols (IQ/ OQ/ PQ/ TMV / Dose Mapping), master validation plans, risk management plans, and summary reports
  • Support day to day activities to ensure manufacturing operations, as well as support corrective maintenance and recipe changes for the sterilizers
  • Support/lead continuous improvement projects
  • Periodic reviews for laboratory equipment
  • Support/lead NCMR and CAPAs
  • Initiate change controls, ensure all impact is evaluated, and obtain feedback from affected departments
  • Process and validation deviations, support/lead.

Sr. Validation Engineer

Deaton Engineering (at ICU Medical)
04.2016 - 10.2023
  • Lead/support validation, and engineering group by generating validation protocols, engineering studies, supporting protocol execution, and leading the review/approval process in a manufacturing environment for IV fluid transfer bags
  • Lead or support the validation efforts required for pharmaceutical manufacturing, facilities/utilities, solution processes, sterilization, and APCS automated process controls systems/software
  • Work with change owners to define changes to validated systems and the testing required per plant operating procedures
  • Assist change owners in presentation of proposed changes and validation approach to a review board
  • Assist change owners in coordinating validation activities with plant operations and other plant supporting functions such as quality testing and instrument calibrations
  • Write and/or review validation protocols, including change requests and installation, operational and performance qualifications, using standard templates
  • Integrate mechanical, quantitative, and qualitative tests into validation protocols as directed by plant operating procedures.

Quality Engineer FAI

Accenture
11.2015 - 04.2016
  • At Accenture support UTAS Aerospace (client) performing first article inspection to engineering aviation manufacturing parts
  • FAI (First Article Inspection) main activities were to provide objective evidence that all engineering, design, and specification requirements are correctly understood, accounted for, verified, and recorded
  • Quality sampling; verify the correct sampling according to the lot size and to nondestructive / destructive test following AQL per standards
  • Geometric dimensioning and tolerance (GD&T); first article inspection against PO and engineering drawing design characteristics such as dimensions, notes, specifications, part list and drawings called out on the part drawing
  • Supplier/Vendor evaluation; non-conformances follow up, certificate of compliance and/or packing slip verification, testing approved by client requirements
  • Customer Service, daily interface with client-vendor to communicate action items and findings to complete the FAI.

Quality Engineer

BME (Biomedical)
03.2013 - 09.2015
  • At Biomedical Enterprises, as a quality assurance engineer responsibility is to execute planned and systematic activities implemented in a quality system, comply with FDA and ISO regulation for a good quality product
  • Report to Director of QA/RA
  • Customer complaints coordinator: follow up all customer complaints received by customer support department of product return for evaluation, investigate to identify what cause the product to fail
  • Corrective and preventive actions coordinator; as a CAPA coordinator is to follow up on daily basis that each CAPA is being followed with the data required to the investigation of the root-cause, corrective and preventive action items concluding with an evaluation for effectiveness of the CAPA
  • Auditing internal and external; conduct internal audits by following a schedule according to the Quality manual
  • Supplier/Vendor evaluation; perform desk audit to non-critical suppliers, coordinate with audit with external company to conduct all critical level suppliers
  • Quality trends report monthly / quarterly / yearly reports; create a trend report with NCMR, CAPA, audits, sold units vs customer complaints, this was presented to senior staff for further improvement projects
  • Support Engineering team on new product development; approve IQR, design and process V&V protocols and reports and approve drawing release, participant of 5 developing phases for new product.

Manufacturing / Project &Validation Engineer

CR Bard Medical Devices
06.2008 - 02.2013
  • Responsibilities to upgrade, maintain, and improve current process (semi-automatic / manually) by performing research on new technologies or upgrading existing equipment, equipment such as custom semi-automated assembly and packaging machines, FFS Multivac forming machines, bar sealers Doboy, ultrasonic welders Branson, dukane sealers and leak testers; Also lead cost improvement and stay in business projects such as material changes, material upgrades, new product development, line extension and supplier material changes between others
  • New Product Introduction: transfer technologies, transfer products
  • Process Mfg
  • Changes, Engineer Changes (Change requests), Manufacturing Validation (Machinery, Process Improvement, Upgrade technology)
  • CAPA and Non-Conformances team/lead
  • Cost Improvement projects (CIP's)
  • Green Belt project to reduce scrap, increase productivity at minimum or no cost.

Product Engineer

Phillips Consumer Electronics
02.2007 - 05.2008
  • Primary objective as a product engineer was to apply and review new product implementation, for pilot runs and manufacturing processes, such as material, line requirements, implementation of new process/technology and packaging adaptation to existing process/tests
  • Engineering change orders (ECO’s)
  • Testing new products
  • Lead manufacturing process validations
  • Assist in developing test methods
  • Maintain and create BOM’s.

Engineer I / Supervisor

Tyco Health Care
05.2004 - 02.2007
  • Main responsibilities were to track all engineer changes and follow up release of ECO, to keep manufacturing lines documentation to latest change and achieve manufacturing schedule
  • Supervise a small group of 5 change order specialists
  • Improved change approval by 25% (Lean manufacturing)
  • Profitability goals hit 8 consecutive quarters, such as on time schedule production
  • Engineering Procedures changes update documents to keep them up to date.

Education

Bachelor of Science in Production Process Engineering -

UTCJ
Juarez, Mexico
05.2005

Skills

  • Validation
  • Engineering
  • Quality Assurance
  • New Product Development
  • Process Improvement
  • ISO 13485:2003
  • 21 CFR Part 11, 210, 211, & 820
  • ISO11137
  • CGMP
  • GAMP 5 risk bases assessment
  • FDA Knowledge
  • FDA Audit Participant
  • Leadership
  • Effective Communication
  • Equipment Qualification
  • Testing protocols
  • CAPA Management
  • Quality Management Systems
  • Validation Protocols
  • Regulatory guidelines
  • Process Validation
  • Change Control
  • FDA regulations
  • Team Leadership
  • Verbal and written communication
  • Complex Problem-Solving
  • Cross-Functional Teamwork

Certification

  • Certified green belt by ITESM and CR. Bard

Languages

English
Native or Bilingual
Spanish
Native or Bilingual

Timeline

Validation Engineer Sterilization (Contractor)

Flex
10.2023 - Current

Sr. Validation Engineer

Deaton Engineering (at ICU Medical)
04.2016 - 10.2023

Quality Engineer FAI

Accenture
11.2015 - 04.2016

Quality Engineer

BME (Biomedical)
03.2013 - 09.2015

Manufacturing / Project &Validation Engineer

CR Bard Medical Devices
06.2008 - 02.2013

Product Engineer

Phillips Consumer Electronics
02.2007 - 05.2008

Engineer I / Supervisor

Tyco Health Care
05.2004 - 02.2007

Bachelor of Science in Production Process Engineering -

UTCJ

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