Validation Engineer - Engineering Resume Search
Validation Engineer - Engineering Resume Search
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Validation Engineer Resume


Desired Industry: Engineering SpiderID: 50106
Desired Job Location: Fort Lauderdale, Florida Date Posted: 4/18/2011
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, 25-50%
Highest Degree Attained: Bachelors Willing to Relocate: Yes


Objective:
Within the interest of seeking the mutual benefit of your organization and yours truly, I am taking this opportunity to introduce myself and to offer my services. Included is a copy of my resume, which contains related information about my qualifications, expertise and personal background.
As a self-starter individual, I have the ability of maintaining a full understanding and up to the moment information of the areas and day-to-day activities. I possess the skill of interacting with personnel from different levels, and consider myself capable of supervising and follow instructions effectively, and in timely manner.
I am looking either for a contract, or direct hiring job position, either as a Senior Validation Engineer, a Quality & Compliance Engineer, an Information Technology Engineer, a Computer System Validation Engineer, or an Electrical Engineer. Preferred working areas could be within Medical Devices, Pharmaceuticals, or Manufacturing companies, but open to others, such as Information Technology, or Telecommunications. I am available to work under a regular working schedule, but also available for after-hours, as required.
I expect a job with clearly defined goals, a good compensation package, a clear description of my responsibilities, and a salary in accordance to my position in the company with enough challenges to develop my capabilities and achieve record performance as a top employee.
I assure you that with my knowledge and experience, we can help the organization to perform more efficient and to grow the technological expertise more than it actually is, giving the business more profitable results.
Your attention is greatly appreciated.
Regards,
Carlos E. Viera-Tirado
vierace@yahoo.com


Experience:
Independent Validation Consultant
February 2010 – present time: Validation Consultant Services (Short/Long-Term Contract)
Primary responsibilities: Provided consulting services and support to validation activities and projects. Generate and review System Life Cycle (SLC) documentation, such as Gap Analysis, HLRA, SOP, Part 11 Compliance Assessments and reports. Keep in compliance with GxP, FDA, ISPE, ISO guidelines and site policies and procedures. Conduct meetings with customer to discuss activities status, and compliance issues. Serve as the subject matter expert (SME) on manufacturing equipment/systems and instruments qualifications and validations non-compliance issues, such as protocol discrepancies/deviations, non-conformance (NCR’s) and troubleshooting/solving activities. Generate memorandums and reports. Evaluate and review GxP documentation associated with the Manufacturing Systems from the Quality and Compliance perspective, which includes document correctness, adequacy, and compliance with the regulatory policies, cGXP, FDA 21 CFR Part 11 rules, and ISO requirements. Provide guidance and training to personnel and contract partners in the execution and review of validation related activities, including SOPs, manuals and protocols where applicable.
CIBA VISION Corporation-DSM Engineering, Duluth, GA
February 2009 – February 2010: Senior Validation Engineer; DSM Engineering
Kelly Engineering Resources at CIBA VISION Corporation, Duluth, GA
October 2008 – February 2009: Validation Engineer (Short-Term Contract; Consultant)
Develop and creates relevant System Life Cycle (SLC) documentation. Review and approves validation documentation, protocols and reports. Provide the execution scope outlined in the validation protocols, including the collection, review, analysis of tests and verification of submitted data and reports. Participates in the validation process and protocols execution of existing and new GMP manufacturing equipments, optical tooling instruments, autoclaves, and computerized systems. Serve as the subject matter expert (SME) on manufacturing equipment/systems and instruments qualifications and validations non-compliance issues, such as protocol discrepancies/deviations, non-conformance (NCR’s) and troubleshooting/solving activities. Review Engineering Studies as pertains to the qualification of existing and new GMP manufacturing equipments, optical tooling instruments, autoclaves, and computerized systems, as applicable.
Assess impact of proposed changes to cGMP related systems. Suggest/implement corrective actions/preventive actions as needed to maintain with cGMP/FDA regulation and Site policies and procedures. Propose recommendations and provide support for non-compliance, missing GMP documentation and policies, lack of controls scenarios, and operational improvements. Keep in compliance with GMP, FDA, and ISO requirements. Regularly meets with internal customers and managers to discuss current and future validation activities. Generates validation-related memorandums and reports. Evaluate, and review of validation related documentation associated to existing and new GMP manufacturing equipments, systems, optical tooling instruments, autoclaves, and computerized systems, viewed from the Quality and Compliance perspective, which includes document correctness, adequacy, and compliance with the regulatory aspects, cGXP, FDA 21 CFR Part 11 rules, and ISO requirements, as required. Provide guidance and training to personnel and contract partners in the execution and review of validation related activities, including SOPs, manuals and protocols where applicable. Experience in the use of GE Kaye Validator 2000 Thermal Validation System.
DMCG Inc., at WCHC, Guayama, PR
June 2008 – July 2008: Validation Specialist – Facilities (Short-Term Contract; Consultant)
Primary responsibilities: Provided consulting services and support to the Wyeth Consumer Healthcare (WCHC) Manufacturing Facilities Upgrade initiative, aiming to define and harmonize requirements for the qualification and validation of GxP areas. Generate System Life Cycle documentation. Keep in compliance with GxP, FDA, ISPE, ISO guidelines and site policies and procedures. Conduct meetings to discuss activities status, and compliance issues. Generate memorandums and reports. Evaluate and review GxP documentation associated to the WCHC Manufacturing Facilities Upgrade initiative from the Quality and Compliance perspective, which includes document correctness, adequacy, and compliance with the regulatory policies, cGXP, FDA rules, and ISO requirements.
MD Pharma Services Inc., at CIBA VISION Corporation-Global Quality Operations, Duluth, GA
October 2006 – March 2008: Lead Remediation Consultant
Primary responsibilities: Provided consulting services and support to the Global Quality System Legacy Validation initiative, aiming to define and harmonize requirements for the Validation of GxP applications, and to initiate remediation projects for GxP applications, associated to Computerized Systems processes. Generate System Life Cycle documentation, such as Gap Analysis, HLRA, SOP, Part 11 Compliance Assessments and Remediation Report. Participates in CSV document evaluation of Legacy Manufacturing Systems, as well as Commercial-Of-The Shelf (COTS) applications. Keep in compliance with GxP, FDA, ISPE, ISO guidelines and site policies and procedures. Conduct meetings with customers to discuss activities status, and compliance issues. Generate memorandums and reports. Evaluate and review GxP documentation associated to Legacy Manufacturing Systems from Quality and Compliance perspective, which includes document correctness, adequacy, and compliance with the regulatory policies, cGXP, FDA 21 CFR Part 11 rules, and ISO requirements.


Education:
EDUCATION
Bachelor of Science in Electrical Engineering, Polytechnic University of Puerto Rico, Puerto Rico
Associate Degree in Electronic Engineering Technology, Technological Institute of Puerto Rico, Puerto Rico


Skills:
PROFESSIONAL/TECHNICAL SKILLS
Validation Skills
• cGxP, GAMP and validation experience
• Experience developing and performing factory/site acceptance testing, validation and decommissioning plans
• Experience creating, developing and executing System Life Cycle (SLC) documentation for automated equipment/systems, optical tooling instruments and computer systems, such as High Level Risk Assessment (HLRA), Qualification Need Assessment (QNA), 21 CFR Part 11 Assessment, SOP’s, Validation Master Plans (VMP), Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Conducts risk assessments and determine revalidation or qualification needs based on gap analysis.
• Experience in developing, review and approval of User Requirements, Detailed Design, and Functional Specifications
• Experience conducting 21 CFR Part 11 assessments of software and computer systems
Quality & Compliance Skills
• Assist to implementing continuous improvements to the Quality Systems required to execute and implement current good manufacturing practices (cGMPs) related to the manufacturing of finished medical devices
• Experience reviewing and evaluating System Life Cycle documentation, Computer Validation Protocols, Analytical Laboratories Protocols, and their applicable SOP’s.; Experience in approval of validations documentation associated to Manufacturing, Process, and Engineering related Manufacturing Equipments/Systems, Optical Tooling Instruments, Computer/Computerized Systems, and Analytical Laboratories Systems.
• Ensuring various departments’ acts in accordance with company policies and procedures, and their compliance with the regulatory aspects, cGxP guidelines, FDA Code of Federal Regulations (CFR) rules, and ISO requirements, were applicable.
Engineering Project Management/General Skills
• Project Management and coordination of validation projects
• Technical writing and presentation experience
• Proficient with Microsoft Office including: word processing, spreadsheet, graphics, and GANT chart development
• Strong ability to manage multiple projects, tasks, and goals with tight deadlines
• Excellent planning, technical, and interpersonal skills with the ability to identify and drive issues to closure
• Ability to communicate effectively, both written and oral.
• Strong analytical and problem solving skills.


Additional Information:
ADDITIONAL OR SPECIALIZED TRAINING
Microsoft Certified Professional (MCP) Preparatory Program: MSMCP100; Knowledge and experience on Microsoft Operating Systems (Windows 9X/ NT 4.0 / 2000 / Xp / Vista Workstation); Microsoft Windows NT 4.0 Server Administering & Supporting; Microsoft Windows NT 4.0 Server Core Technologies seminars; Configuring and Troubleshooting Windows Server 2008 R2 Network Infrastructure; Configuring, Managing and Maintaining Windows Server 2008 Servers; Microsoft Office Professional & MS Project applications; Email applications: Lotus Notes, MS Outlook.


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