Computer Validation Compliance Engineer/Consultant Resume Aiken, SC - Hire IT People

SUMMARY:

Extensive Computer System Validation, Technical Procedural Writer, and product processing background. Thorough knowledge of FDA regulations, cGMPs, OSHA and validation industry standards. Extensive computer validation project development in establishing documentation, reviewing and approving master documentation, and computer validation training. 23 years experience in manufacturing processes with 15+ years in the technical field of process development & computer system validation of applications & software.

EXPERIENCE:

Confidential, Aiken, SC

Computer Validation Compliance Engineer/Consultant

Responsibilities:

Created and standardized CSV project generic governance documents that increased efficiency by 40 hrs per project and improved consistency of computer system validation documentation to current industry standards in conformance with federal regulations.
Identified and standardized business process procedures for computer system within finance, planning, and information technology systems minimizing deviations and improving quality.
Established and implemented IT CSV Lifecycle Quality Management procedure that became "1st factory" meeting corporate initiative of 1 procedure per factory.
Managed and executed validation deliverables for various major computer systems centrally & locally. Met aggressive go - live timelines, replaced legacy systems, increased innovation and value of performance.
Received 2 Global Management System Excellent Awards for the implementation of two innovated systems by "contributing with passion and an unmatched sense of urgency".
Managed CSV quality compliance by meeting factory, corporate, federal and foreign inspections demonstrating regulatory control with no major findings.
Developed, qualified and certified core validation team authors, approvers, super users and testers by becoming 1st and only certified Global Computer Validation Integrated Quality Management System trainer and grader for North America sites.

Confidential, Aiken, SC

Owner / Operator

Responsibilities:

Provided care for up to 10 children, in accordance with Federal and State laws and regulations, including SC Department of Labor, Division of Fire and Life Safety, and Department of Health and Environmental Control.

Confidential, Aiken, SC

Process Engineering Resource

Responsibilities:

Administered and documented training on operation, and validation cleaning, in-process testing procedures and sampling requirements.
Prepared and maintained all documentation required for process and project operations.
Assisted and executed validations on approximately 75 different equipment.
Worked in a team-structured environment and interfaced with Process Development groups, Quality Assurance groups, Regulatory and Compliance personnel, R&D Category teams, Engineering personnel, site personnel and outside suppliers and representatives.

Process Research Scientist / Coordinator,

Confidential

Responsibilities:

Assisted with design of experiments and plant trials validating 3 new products for consumer sell.
Conducted training and maintained training program records for 10 people?
Created and maintained procedures, master batch records, IQ/OQ/PQ, cleaning records, lab data sheets, tables and forms for process data recording required for plant operation.
Assisted manager with administration issues such as budgets/finance, materials management/ procurement/logistics, and health/safety.
Purchased raw materials, operation and cleaning supplies, repair parts, change parts needed to operate plant and laboratory operations. Performed chemical and physical analytical testing in accordance to Quality Compliance Standards (QCS) specifications.

Manufacturing Technician / Temporary Supervisor

Confidential

Responsibilities:

Performed job task to manufacture products, operating a wide variety of manufacturing process equipment while following cGMP, PMIs, SOPs, and OSHA guidelines.
Directed the day to day activities of others while in a temporary supervisor position, including performing multiple task when necessary i.e., perform daily operations, write procedures.
Assisted supervisors and engineers with equipment qualifications and validations.
Developed, and performed PRISM application training to 25 manufacturing technicians.

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Computer Validation Compliance Engineer/consultant Resume

Aiken, SC

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