SUMMARY

• Over 7 years of experience as aValidationEngineerworking on Commissioning and Qualification of manufacturing equipment, automated systems, validation of process and computer systems and equipment software
• Excellent experience in computer system validation and FDA guidelines
• Excellent experience in authoring SOPs and WIs
• Familiar with 21 CFR Part 11, 820 and ISO 13485
• Developed and executedvalidationprotocols and SOP's for Qualification (IQ, OQ, PQ) for equipment HMI and PLC systems, automated process equipment and packaging vision systems
• Authored and executed FAT, SAT, Installation and operational qualification (IOQ) and performance qualification (PQ) for automated equipment, systems and Cold rooms
• Experienced in preparing documents such asvalidationprotocols that includes Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) andValidationSummary Reports (VSR) of Controlled temperature units like ovens, incubators, freezers and refrigerators
• Authored and executed Commissioning Test Plan (CTP), Installation/ Operational Qualification (IOQ), Performance Qualification (PQ) for the Sterilization Systems
• Experience in Validation of HVAC Systems, RODI water systems, Utilities and clean rooms
• Very good understanding of P&ID diagrams
• Managed all aspects of design, executedValidationProtocols such asValidation Plans (VP), Commissioning Protocols, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Turn Over Packages (TOP)
• Created and executed qualification protocols and accurately recorded, compiled and summarized results using good documentation practices
• Updated requirement traceability matrices for Freezers, Autoclave and incubators
• Strong knowledge and working experience with cGxP (GMP, GDP, GLP, and GAMP) standards
• Participated and coordinated efforts to resolve investigations and CAPA
• Knowledge on enterprise quality management software - Track Wise, enterprise document management system
• Responsible for LIMS database, training, maintenance, routine data archrivals, backups and retrievals
• Demonstrated critical thinking skills and ability to independently develop methods and specification
• Enthusiastic, self-motivated, highly organized team player with leadership skills and possess excellent communication skills

TECHNICAL SKILLS

• CSV
• Computer System Validation
• QA Methodology
• IQ
• OQ
• PQ
• UAT
• CAPA
• CQV
• Commissioning / Qualification and Verification (CQV) Engineer
• Validation engineers
• AHU’s compressed air
• WFI
• Validation Utilities
• SAT or FATs
• GMP
• GMPX
• SOP
• Process Engineer
• Process Validation
• Data Integration
• Cleaning Validation
• Dissolution Baths
• Tablet Press
• Encapsulator
• Ultra-Performance Liquid Chromatography (UPLC)
• High Performance Liquid Chromatography (HPLC)
• Deduster
• Product Blender
• Check
• Weigher or Metal Detector
• Induction Sealer
• Qualification of new equipment
• Fluid Bed Dryer
• Freezer
• Refrigerator
• Veeva QMS
• FDA regulations
• ISPE guidelines and ISO standards including
• QMS systems data and processes
• ST or UAT activities
• Traceability Matrix
• Veeva Quality
• SDLC
• Quality Analyst
• CQV
• Installation
• Qualification

PROFESSIONAL EXPERIENCE

Confidential, IL

Sr Validation Engineer

Responsibilities:

• Responsible for the creation of qualification and validation programs (Equipment, automated systems and Computer Systems) for the manufacturing site, the Quality Control (QC) laboratory, and facility support systems.
• Developed criticalvalidationlifecycle documentation to support the qualification/validationof equipment, software and facilities (IQ, OQ and PQ protocols, Operational SOPs, PM SOPs, Change Controls, User/Functional/Design Specifications)
• Responsible for validation and implementation of PLC, HMI and SCADA software for control systems and equipment
• Responsible for validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software(PLC's and HMI's) design, commissioning, and testing to meet end user requirements
• Developed validation and testing documentation such asValidationPlan Summaries, Test Plans Summaries, URS and FRS, RTM, Qualification Protocols and scripts for PLC, HMI and MES applications as well as documentation of testing defects
• Qualified HVAC systems and also performed Bio-Burden and Pyrogen testing for clean rooms.
• Supportvalidationlife cycle activities by commissioning, continuous process monitoring, change controls, SOP generation, and revalidation activities
• Responsible for the preparation/ execution IQ/OQ/PQ protocols for equipment, facility and utilities as well as related software. Generated qualification report and summarized the results for management review
• Performed re-qualification of equipment, facility and utilities as required
• Identified deviations encountered during IQ/OQ/PQ execution and worked with engineering to implement mitigations
• Executed equipment qualification protocols and accurately documented results of the defined testing; then comparing and reporting those results to predefined/approved acceptance criteria
• Supported the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
• Support the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure.
• Drafted SOPs for new operational equipment.
• Supported process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service.
• Worked with equipment vendors to collect equipment manual and other required documents.
• Closely worked with the maintenance & facility teams to complete new equipment installation as per project requirement
• Experienced in drafting Deviation Reports when the test results failed to meet the acceptance criteria
• Performed Root Cause analysis for all the deviations and generated Corrective and Preventive Action plan

Confidential, NJ

Validation Engineer

Responsibilities:

• Developed and executed IQ/OQ/PQ protocols and completed reports for equipment, process utility, test, and software validations and revalidations
• Developed Standard Operating Procedures, protocols, incidents, and final reports for new processes and equipment, in conjunction with the system owners
• Supported department projects by assisting senior engineers on ongoing projects
• Performed Preventive Maintenance and Calibration tasks as required following existing procedures
• Prepared protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations.
• Responsible for Preparation and review of associated procedures, change controls, standard operating procedures, validation master plans
• Executed protocol and related activities associated with validating equipment/ systems/ utilities/ processes, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Performed statistical analysis for process monitoring.
• Preparation, execution, and review of laboratory equipment validations and analytical data
• Supported internal and external audits by providing data appropriate to the investigation as required
• Developed and executedEquipmentQualificationplans and protocols for manufacturing and packaging equipment
• Generate FMEA documents, validation test protocols, validation reports, other required documents, and perform statistical analysis to support validation activities.
• Supported the investigation of deviations, troubleshoot problems, and determines solutions
• Created and executed commissioning, qualification protocols, and validation protocols (CP/IQ/OQ/PQ/PPQ), including identification and resolution of exceptional conditions
• Provided equipment, system and facility commissioning and qualification guidance and strategy execution during project planning and development phases
• Oversaw and managed validation instrument inventory including calibrations and/or certifications
• Reviewed technical documentation including protocols & summary reports for CQV lifecycle documentation, other testing, and validation SOPs
• Performed temperature mapping and other miscellaneous validation activities
• Managed contractors performing equipment and system commissioning, qualifications, and validation
• Supported process and method transfer validation activities, as necessary by manufacturing and Quality Control labs.
• Reported status and progress of qualification activities or projects to the Leadership team
• Performed investigations and implement corrective actions related to CAPAs and deviations
• Developed technical specifications documents necessary for generation and/or execution of CQV lifecycle documentation

Confidential, NJ

Validation Engineer

Responsibilities:

• Responsible for validation of Process, Computer System Validation, Equipment and Instrumentation Qualification, Test Method Validation, and Facility and Utility Qualification
• Planned and performed validation activities, including Installation Qualification/Operations Qualification/Performance Qualification (IQ/OQ/PQ)
• Performed re-qualification of equipment, facility and utilities
• Identified deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
• Drafted Standard Operating Procedure (SOP) for new operational equipment
• Compiled and analyzed validation data, wrote protocols, reports and made recommendations for changes and improvements
• Facilitated and supported validation training, change management, and periodic review of validated systems
• Collaboratively conducted Risk Assessments and Impact assessments, and established system boundaries
• Generation, Review and editing of Standard Operating Procedures. Review and verification of ETOP’s.
• Generation and execution of protocols for DQ, FAT, SAT, IV OV, IQ, OQ, and PQ
• Supported equipment troubleshooting and close out of discrepancies and deviations
• Responsible for the site requalification plan execution and implementation. Streamlined testing requirements while maintaining regulatory and corporate compliance.
• Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews.