Gerardo Castillo

Gerardo Castillo Email and Phone Number

Validation Director @ Hughes Engineering, PLLC
Greenville, NC, US
Gerardo Castillo's Location
Greenville, North Carolina, United States, United States
Gerardo Castillo's Contact Details
About Gerardo Castillo

Over twenty (20) years of results oriented experience in manufacturing process, both pharmaceutical and medical device environment. Competitive and responsible, with excellent communications skills, highly motivated, organizational skills, and able to work with minimum supervision. Run all requirements for successful team work and virtual team work, problem solving, highly technical and analytical oriented. Fluent in English and Spanish, and MS Office applications. Daily worked with scientific equipment, validation documents, quality investigations, SOPs, process improvements, safety and regulatory requirements (FDA, ANVISA, INVIMA, TCA and JPMD).

Gerardo Castillo's Current Company Details
Hughes Engineering, PLLC

Hughes Engineering, Pllc

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Validation Director
Greenville, NC, US
Gerardo Castillo Work Experience Details
  • Hughes Engineering, Pllc
    Validation Director
    Hughes Engineering, Pllc
    Greenville, Nc, Us
  • Hughes Engineering, Pllc
    Validation Director
    Hughes Engineering, Pllc Oct 2022 - Present
    Raleigh, North Carolina, Us
  • Merck
    Assoc. Director, Global Engineering Services Dublin Cq
    Merck Aug 2021 - Oct 2022
    Rahway, New Jersey, Us
  • Thermo Fisher Scientific
    Validation Manager
    Thermo Fisher Scientific Jan 2018 - Aug 2021
    Waltham, Ma, Us
  • Zimmer
    Validation Manager
    Zimmer Oct 2014 - Jan 2018
    Warsaw, Indiana, Us
    • Responsible for the successful planning and execution of Zimmer Biomet validation activities for the site. Responsible for the harmonization and adherence of validation activities in accordance to Global and Site procedures. Responsibilities also includes Metrology Engineering to support improvements, changes and implementation of measurement systems as well as automated measurement program control. Responsible for the most important site project, the remediation project “Machining Process Control” including the implementation of new product characteristics critical to quality; a multi-million initiative to enhance and robust the site compliance level.
  • Pfizer
    Technical Services Sr. Supervisor
    Pfizer Jan 2007 - Feb 2014
    New York, New York, Us
    • Responsible for product transfer and formulation, materials changes, process changes and optimizations, packaging validation. • Technology/Process Lead for new multi-million-plant expansion, equipment installation, commissioning, qualification and startup. Hands on discussion with software developers and review teams to bring benefit, value with quality to the user.• Generate, review and approves master records, protocols, reports, risk assessment, validation plans, cleaning risk base plans, labeling work sheet, Validation Master Plan, department budget, investigations/CAPA, and SOPs.• Network SME for Dietary Supplements (Support sites from other regions) • Work directly with solid dosage manufacturing processes and equipment, from Weighing to Film Coating including Bottle packaging.
  • Pfizer
    Senior Project Manager
    Pfizer Jan 2002 - Jan 2007
    New York, New York, Us
    • Responsible for generation and tracking project schedules, resource distribution, cost and budget management, project ROI/feasibility evaluation. Multi departmental and external site support coordination as needed.• Development and completion of the area to perform Accelerated Stability and excursion studies
  • Abbott Labboratories
    Senior Scientist
    Abbott Labboratories Jan 2001 - Jan 2002
    • Hormone therapy process Improvement. Potent compound handling and production usage. • Development of Process validation, Stability Studies, Equipment qualification, and Computer validation.• Vision System improvement, Full packaging line installation and qualification.• Creation and coordination of Change Control committee.
  • Wyeth Pharmaceuticals B.V.
    Research Scientist
    Wyeth Pharmaceuticals B.V. Jun 1997 - Jan 2001
    • Worked with Product transfer and development of Multi-drug product, OC (hormone therapy, contained system), Sugar coating• Compression DOE • Utility Validation Identified potential problems for new and existing equipment

Gerardo Castillo Skills

Corrective And Preventive Action Process Validation Management Product Launch Contract Manufacturing Product Development Pharmaceutical Industry Change Control Cmo Standard Operating Procedure Validation Statistics Strategic Planning Computer System Validation Cleaning Validation Equipment Qualification U.s. Food And Drug Administration Gmp

Gerardo Castillo Education Details

  • University Of Puerto Rico-Mayaguez
    University Of Puerto Rico-Mayaguez
    Chemical Engineering

Frequently Asked Questions about Gerardo Castillo

What company does Gerardo Castillo work for?

Gerardo Castillo works for Hughes Engineering, Pllc

What is Gerardo Castillo's role at the current company?

Gerardo Castillo's current role is Validation Director.

What is Gerardo Castillo's email address?

Gerardo Castillo's email address is ge****@****her.com

What schools did Gerardo Castillo attend?

Gerardo Castillo attended University Of Puerto Rico-Mayaguez.

What skills is Gerardo Castillo known for?

Gerardo Castillo has skills like Corrective And Preventive Action, Process Validation, Management, Product Launch, Contract Manufacturing, Product Development, Pharmaceutical Industry, Change Control, Cmo, Standard Operating Procedure, Validation, Statistics.

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