validation engineer resume example with 6+ years of experience
Enthusiastic individual with superior skills in working in both team-based and independent capacities. Bringing strong work ethic and excellent organizational skills to any setting. Excited to begin new challenge with successful team.
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Authored Protocols and execution of filling lines, filling equipment,
cleanroom and utilities.
Perfomed qualification activities for New, modular cleanrooms, utilities, and 10-12 aseptic filling lines.Product is liquid media "viral transport media" for COVID-19 test kits.
- Authored Validation Project Plan (VPP) and performed System Impact Assessments (SIA), Risk Assessments, GMP Alarm assessments, GXP evaluations, Electronic Records and Electronic Signature (ERES) assessments, IOQP protocols for Filling and Packaging lines.
- Performed Material assessment to determine the storage conditions of finished products, work in progress material, Active Pharmaceutical Ingredients (API's), excipients and manufacturing components (e.g.
- Vials, ampoules).
- Performed validation studies to determine the worst-case locations for the placement of temperature and humidity sensors in Freezers, Incubators, Stability Chambers and Refrigerators.
- Reviewed the executed data and developed final summary reports.
- Resolved deviations encountered during IOQ executions by investigating the root cause and Corrective Action assessments.
- Maintained the Requirement Traceability matrix and verified all process, performance and quality critical user specifications are met during qualification activities.
- Performed 24 hours and 72 hours temperature and humidity distribution studies in controlled Temperature Units to include Freezers, Incubators, Stability Chambers and Refrigerators.
- Generated, executed and reviewed Temperature and Humidity Distribution Assessment Protocols and developed summary reports upon completion of the approved execution.
- Coordinated with cross functional departments and organized meetings to schedule thermal mapping studies.
- Prepared and executed IQ, OQ and PQ protocols for Air Handling (HVAC) systems for shut down support.
- Performed Gap Analysis and developed Remediation plans.
- Collaborated with Quality and manufacturing for Validation activities, analyzed the results from validation and provided effective resolutions to the issues observed.
- Investigated and reviewed CAPAs to ensure they were completed on time and in compliance with regulations.
- Reviewed change request forms, documentation, summary reports for product specific CAPAs along with tracing Aging records to completion.
- Responsible for tracking all product related CAPAs and ensure they are in compliance with FDA regulations.
- Investigated equipment failures, identified causes and initiated methods to resolve such issues.
- Inspected, calibrated and tested instruments used to manufacture medical devices.
- Presented complex technical data in easily understood terms to individuals without engineering backgrounds.
- Developed and executed the commissioning procedures and installation and operational qualification for utilities.
- Reviewed utilities commissioning and qualification documents.
- Author, review and approve initial Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) validation protocols, periodic review, re-qualification protocols for a variety of manufacturing and packaging equipment.
- Prepared and executed IQ, OQ and PQ protocols for Air Handling (HVAC) systems and process equipments such as Portable Tanks, Pumps, and Portable CIP systems.
- Analyzed IOQ and Commissioning protocols, developed summary reports for various process equipment in solid dosage manufacturing facility like API Weigh/Dispense System, M Mill System, Tablet collection system, Tablet coating system, Coating testing system, blending system, Excipient Weigh/Dispense System, Compression Testing system, Dry Granulation Testing System, Wet Granulation Testing System.
- Developed RTMs for process equipment by gathering the information from URS, Risk assessment, Alarm specifications, Functional Specification and other documents.
- Performed IQ tests like Field Wiring verification, component ID tagging, P&ID verification, Material of construction for equipment like Process equipment (FLM-3, Coating System, Wet Granulation, Dry Granulation, Comill, Parts washer, Blending System, Coating Testing System).
- Developed and executed the commissioning procedures and installation and operational qualification for utilities.
- Reviewed utilities commissioning and qualification documents.
- Performing the verification and inspections walk downs for utilities.
- Working with the manager and team to support the preparation of specification, design, commissioning, qualification/ validation documents for the review and approval process.
- Conducted experiments like Recrystallization, Thin layer chromatography, Column chromatography, Grignard synthesis of Triphenylmethanol reaction.
- Assisted students in handling equipment's like UV Spectrophotometer and Mass Spectrometer.
- Maintained lab equipment, records and materials by following GLP protocols.
- Authored lab protocols, technical reports and SOPS.
Ms. Jessica Claire is a pharmaceutical professional with extensive experience in Commissioning & Qualification for utilities and Oral Solid Dose (OSD), validation, compliance, manufacturing, investigation, CAPA, FMEA and change control. She has extensive understanding of commissioning and qualification and is familiar with cGMP's, pharmaceutical, industry standards, P&IDs, support systems, and process utilities. Ms. Claire' s additional experience includes plant start-up projects and validation efforts (cleaning, biotech, fermentation, oral solid dosage, sterile manufacturing/filling, packaging, clean utilities and clinical facilities). Commissioning & Qualification, Utilities, Oral Solid Dose, CAPA, FMEA, Change control, cGMP (21 CFR part11), CSV Qualification, SIAs, CAs, RAs, FATs, SATs, IQ/OQs, PQs, Traceability Matrix Verification and Validation Reports and SOPs Equipment/System Expertise Oral Solid Dosage manufacturing, packaging and utilities equipment Commissioning, calibration and validation HVAC, WFI, clean steam, USP PW, RO/DI water, compressed air, vacuum Validation Protocols and Summary Reports Sterile injectable and oncology products Involved in installation and manufacturing Involved in Gap Assessment Commissioning and Qualification Processed Air, Compressed Air, Nitrogen System, Misting showers, Purified water Utilities Commissioning and Qualification FLM3, Wet granulation, Dry Granulation, Comil, Tablet Press, Encapsulation, Parts Washer Validation Protocols, Reports and Execution
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Resume Overview
School Attended
- <li>University of Houston-Clear Lake</li><li>B. Pharmacy, Kakatiya University</li>
Job Titles Held:
- Validation Engineer
- Validation Engineer
- Genentech, CA, Validation Engineer
- Research & Lab Assistant
Degrees
- Master of Science
By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy