The job role of a Validation Specialist is to manage process validations and provide technical support. Highlighting duties listed on successful Validation Specialist Resume are – implementing operating procedures, analyzing validation test data, identifying deviations, conducting qualification tests on existing and new products, studying product characteristics, conducting internal audits, determining gaps in service, ensuring operations comply with the organization’s standards, and streamlining the workflow of information or data.
Those interested in this occupation should depict these skills – knowledge of process validation and equipment knowledge, relevant technical skills, familiarity with programming languages, and strong analytical skills. Candidates having a bachelor’s degree or an associate’s degree gain eligibility to work as Validation Specialists. However, some positions want the candidates to have a technical education and experience in the relevant area of work.
Worked in a remediation process in manufacturing based on recognizing problems, fixing them and closing the gaps.
Developed a corrective action plan that gets to the root cause and remediation in a timely manner.
Developed and implemented procedures for Validation Activities.
Prepared, reviewed, executed and summarized validation protocol and report manufacturing process and develop cleaning procedures.
Performed and execute Cleaned Validation activities for such as VP, VPR, IQ, IQR, CSV, CSVR OQ, OQR PQ, QPR for manufacturing equipment.
Worked with Change Management System and DMR.
Provided training to other colleagues and external contractors in tasks related to the manufacturing processes and work instructions.
Experience
2-5 Years
Level
Junior
Education
MBA
Validation Specialist II Resume
Headline : Professional with a great foundation built on experience in production, product, and business processes. This experience facilitated in building rapport with peers and business representatives.
Executed and tracked qualification documents for the Process Control System (PCS).
Prepared regulatory documents for submission including applying naming conventions, acquiring references and source documents.
Executed alarms, phase testing, and document searches.
Interfaced with publishing and regulatory staff to ensure submissions are reviewed, approved, and processed efficiently.
Assisted with reviewing submission documentation for completeness, consistency, and compliance with applicable regulations and guidelines.
Executed Installation and Operation Qualifications for Process Control Systems.
Archived of manually pre-approved qualification protocols and executed post-execution approved protocols.
Experience
5-7 Years
Level
Executive
Education
Diploma
Validation Specialist II Resume
Headline : Experience in Validation, Quality Assurance and Technical Services. Background is a broad based GxP experience in all aspects of global regulations across all regulatory science.
Designed and performed equipment installation and operational qualifications.
Investigated process and equipment changes and recommend the necessary re-validation or re-qualification studies.
Reviewed and evaluated Production Batch Records and recommend changes based on Validation study results.
Reviewed and evaluated plant operating procedures and recommend procedure changes based on validation/qualification study results.
Served on assigned project committees to review validation and qualification studies.
Directed activities of Production personnel, validation technicians or other personnel integral to validation and qualification studies.
Monitored stability program results from validation studies and summarizes the data in reports along with conclusions and recommendations.
Experience
5-7 Years
Level
Executive
Education
Master's
Validation Specialist/Executive Resume
Headline : Participate in validation, temperature mapping, and calibration activities. They measure instrument or software performance to determine if tools are performing as described.
Skills : Office Procedures, Technical Skills.
Description :
Followed SOPs and Validation Plan in carrying out different validation activities.
Analyzed Systems Requirements Specification (SRS) and System Design Specification (SDS), developed Test Plan.
Reviewed SRS, URS, SDS, Test plan, pre, and post executed test scripts, Validation Summary report.
Reviewed the Traceability Matrix to ensure that all requirements are tested.
Reviewed pre and post executed test Scripts developed and executed by other testers against SRS.
Provided guidance to other testers in handling test script errors and created defect reports according to company guidelines.
Bugs identified were documented by creating an Incident Report manually.
Experience
5-7 Years
Level
Executive
Education
Diploma
Validation Specialist I Resume
Objective : To obtain an position that leads too an career. A career that believes education is just as important as experience and growth within the position.
Skills : Excel, Medical programs.
Description :
Verified and processed a high volume of vendor invoices for seasonal and event snow.
Interacted regularly with vendors and internal partners.
Frequented phone calls and emails to vendors for required documentation.
Able to understood specific customer billing requirements.
Monitored daily unbilled reports Identify, monitor and escalate inaccuracies and discrepancies timely.
Assisted other members of the group with invoice validation and contacting vendors for paperwork as required by the validation manager.
Assisted in the Document Control process as needed which may include receiving, organizing, distributing and scanning vendor paperwork.
Built relationships with external and internal clients to assist job seekers.
Experience
2-5 Years
Level
Junior
Education
BS
Validation Specialist/Analyst Resume
Headline : Data validation specialists are responsible for ensuring the accuracy of information entered into an organization's electronic systems.
Skills : Computerized System Validation, Project Coordination.
Description :
Authored, developed, executed, reviewed protocols (IQ.OQ, PQ) and final reports for process equipment, facilities.
Experienced with validation change control processes.
Worked to ensure utilities and equipment parameter defining processes.
Ensured efficient workability and/or flow to meet regulations provided by such acceptance criteria.
Contacted with engineering and outside vendors to troubleshoot then ensure the resolution of any and all related issues/ discrepancies.
Assisted in IOQ's for CIP bioreactors, transfer panels, and utilities.
Worked safely is a condition of employment.
Experience
5-7 Years
Level
Executive
Education
BA
Validation Specialist/Technician Resume
Objective : Compilation and review of vendor documentation, and preparation and execution of CD and IQ/OQ/PQ protocols for pharmaceutical facilities including critical utilities.
Skills : Technical Skills, Analytical Skills.
Description :
Responsible for the generated and executed of the IOQ protocols for the Honeywell Paperless Chart Recorders.
Developed the Validation Plan for the Calibration Manager and the Cold Chain Manager.
Developed the IQ and PQ protocols for the Calibration Management System.
Responsible for the execution of the IQ protocol for the Calibration Management System.
Developed and executed the IOQ protocol for the Honeywell Paperless Chart Recorder, the PLC and OIT for the Cold Room.
Assisted with the execution of the IQ/OQ Protocol Amendments for the Chromatography Systems.
Developed the Operational Qualification Protocol Amendments for the Bioreactors.
Experience
2-5 Years
Level
Junior
Education
B.S
Asst. Validation Specialist Resume
Objective : Extensively worked with Product Development to bring new products to the commercial floor and Technical Services with improvements to current processes.
Skills : Excellent Computer skills, Medical insurance.
Description :
Scheduled validation activities and materials with production and established timelines to complete work.
Executed and prepared final packages for warehouse thermal mapping protocols.
Executed and prepared final packages for walk-in cooler thermal mapping protocols.
Generated, executed, and prepared final packages for qualification protocols.
Generated re-qualification protocols to continue the validated status of equipment as a part of company validation policies.
Generated User Requirement Specification (URS) documents for imprinters.
Revised documents including the blender URS and processed through the Change Control system.
Experience
2-5 Years
Level
Junior
Education
Process Engineering
Validation Specialist/Co-ordinator Resume
Objective : Prior experience in mechanical areas of the Pharmaceutical Industry. Areas of strength include facility, equipment, utility, process and cleaning validation, commissioning.
Skills : Problem Solving Skills, Analytical Skills.
Description :
Assisted with walking down and verifying plant P&ID's.
Trained in gmp procedures for plant documentation.
Responsible for coordinated timelines and validation efforts.
Responsible for oversaw team management and assigning duties.
Responsible for the preparation, review, and execution of Installation and Operational Qualification (IOQ) protocols for the HVAC System.
Led also coordinated with the validation of the Siemens HVAC Controls.
Developed protocols for OQ Packaging Vacuum System.
Experience
2-5 Years
Level
Junior
Education
AS
Validation Specialist/Director Resume
Objective : Proactive, self-motivated, quick learner seeking Office Administration position with a company or organization where can utilize skills.
Skills : Quality Auditing, Quality Systems Remediation.
Description :
Participated in various projects for legacy and new packaging equipment.
Developed validation documents such as IQ/OQ/PQ protocols, Commissioning Documents, Engineering studies for existing processes.
Developed summary reports for completed validation studies.
Performed Factory Acceptance Test (FAT) to pre-qualify equipment prior to delivery to the client manufacturing site.
Performed Site Acceptance Test (SAT) following equipment delivery.
Participated in projects to support equipment validation.
Complied with FDA regulations. Obtain samples to be analyzed per qualification/validation protocol requirements.
Experience
0-2 Years
Level
Entry Level
Education
Certified ISO
Validation Specialist Resume
Headline : To obtain a rewarding career in which can demonstrate knowledge of the Quality System. This includes verifying the functionality, quality and security of a product or service and determining if it meets marketing objectives.
Skills : Analytical Skills, Technical Skills.
Description :
Developed final reports for IQ/OQ facility protocols.
Generated and investigated Non-Conformance Reports (NCRs).
Utilized quality tools such as Fishbone Diagram for Root Cause Analysis.
Implemented Corrective and Preventative actions.
Performed and assisted with CAPA Effectiveness monitoring to ensure Corrective Actions are sustained.
Performed GAP analysis between FDA Regulations and corporate/site procedures to verify compliance.
Documented testing results invalidation/qualification protocols as per protocol requirements.
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