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JC
Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Professional Summary
Certified Lean Six Sigma Green Belt *Highly experienced and enthusiastic pharmaceutical engineer in Biotechnology and Pharmaceutical industry *Risk Assessment and FMEA/ Change Control and CAPA./Process Validation/Cleaning Development (CIP) *System life cycle management/ Management of GMP controlled Document *Equipment Qualification (IQ,OQ,PQ) and commissioning *Working knowledge of process validation, statistical methods, risk management *Good Documentation Practice/ Good Manufacturing Practice/21CFRPart 210/211/11/820 *Excellent communication skills, team player with strong problem solving abilities. *Experienced in the validation of support systems, clean environments, processing equipment, utilities as well as processes by planning and coordinating the communication for prerequisites, resources, schedule and sequence of execution with cross-functional team members. *Hands-on working experience in the validation/qualification of processing systems, equipment, utilities and clean environments. *Good understanding of development of technical packages (URS, FRS, SOPs,), project plans, risk assessments, change controls and validation master plans *Good Knowledge of Quality Assurance experience in a QSR (GMP), disposable medical device environment Cell Operating System Experience working in a team environment Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42 EEC).
Skills
  • Guest services
  • Inventory control procedures
  • Merchandising expertise
  • Loss prevention
  • Cash register operations
  • Product promotions
Work History
03/2015 to Present Validation Engineer Iconma, L.L.C. | New York City, NY,
  • Responsible for Protocol Execution and Report Writing of Filter Integrity Tester.
  • Responsible and involved in Decontamination cycle development study and PQ execution of autoclave.
  • Perform commissioning activity such as Completing Engineering Turnover package, Intro package, and mechanical completion for system likes Particle management system, freezers, Refrigerators.
  • Prepared Functional and component criticality assessment completion for equipment used in sterile manufacturing.
  • Executed critical test protocol and non-critical test protocol including empty and loaded chamber by temperature mapping using thermocouples, data loggers and Kaye Validator.
  • Provide support services to process owners in thermal mapping activity for Lyophilization system.
  • Performed System level impact assessment for equipment such refrigerator, freezer.
  • Responsible for the resolution of deviations, CAPAs, root cause analysis techniques during deviation investigational process.
  • Principal Investigator for All major Deviation for Temperature mapping study.
  • Uses portal such as eRoom, eDOC, ISOtrain on daily basis.
to Bickford Senior Living | , IA,
  • Provide support services to process owners to author and execute validation protocols for IQ, OQ, and PQ for the processing equipment as well as utilities and facility are utilities such as HVAC system, USP water, Clean Compressed air, Nitrogen as well as processing equipment such as homogenizer, processing skids, dispensing and filling are qualified / validated to current regulatory requirements.
  • Authors and execute the qualification of production equipment.
  • Developing and executing the IQ, OQ, PQ of production equipment's related to Topical manufacturing for e.g.
  • Ross Homoginizer, Pharmalab, Becomix etc and support equipment such as refrigerators, ovens, stability chambers, etc.
  • Resolve deviations, analyze test results and prepare final Reports for all qualification and validation projects.
  • Perform facility and utility qualification, which includes developing and executing the IQ/OQ/PQ for Purified Water System, Compressed Air Systems, Nitrogen System, HVAC System and Area Qualification.
  • Regular monitoring and tracking of instrument calibration reports for all equipment and HEPA filter certification, airflow balancing etc.
  • including troubleshooting and coordination.
  • Qualification of stability chambers using data loggers, to accommodate stability sample storage requirements.
  • Create Standard Operation Procedures (SOP) for Setup, operation and Preventive maintenance of production equipment's and facility utilities.
  • Provide validation requirement inputs to the design engineering and construction team members to assure desired features and capabilities are part of the installation to achieve desired cleanliness, segregation and sampling on an ongoing basis for the pharmacy room, processing rooms, utility room, packaging, warehouse, staging and shipping.
  • Daily activity also includes acquiring quotation from different vendors and issuing purchase orders for procuring required parts.
01/2015 to 12/2015 Validation Engineer & Teaching Assistant Living Spaces Furniture | Phoenix, AZ,
  • Performed Design of Experiment (DOE) and Statistical Process Control studies (SPC) as a part of the process development, improvement, simulation to get a product of desired specifications.
  • Process Capability, Gage R&R, ANOVA using Minitab 17.
  • Prepared SOPs, URS (User Requirement Specification), Validation Master Plan, Validation development and protocols (Design qualification, IQ, OQ, PQ, Cleaning validation, Temperature Mapping).
  • Analyzed the data and process using Minitab-17 (DOE, Control charts, Gage R&R) and Made necessary changes to get the product of desired specification and reduce variability.
  • Worked with a team for technical review of cGMP documentation for compliance to cGMP.
  • Prepared GMP documentation in support of production activities.
  • Identified various deviations from the process and performed Root Cause Analysis and implemented CAPA.
  • Determined critical process parameter for manufacturing of pharmaceutical product using FMEA/FMECA.
  • Learned and used Electronic Document Management System (M-Files) to increase the working efficiency.
  • Executed IQ, OQ and PQ protocols for manufacturing equipment and Process Validation at lab scale.
  • Performed and coordinated for internal audit to ensure compliance of research center with cGMP Standards (21CFR Part 210/211/11/820).
  • Gained the knowledge of Kaye Validator - GE, Minitab 17, Sievers TOC Analyzer.
  • Validated the analytical method as well as the process parameter used in various steps using Minitab software.
  • Prepared SOPs and protocols, Documented all SOPs and protocol as per cGMP.
08/2012 to 01/2015 Product Specialist Biocon Pvt. Ltd | City, , India
  • Prepared IQ/OQ documents for autoclave and PQ for their load qualification.
  • Supported authoring of validation protocol and their execution.
  • Team member for review and approval process of quality policy and batch records documents.
  • Participated in review and approval process of Functional Requirement for "GMP Critical" equipment.
  • Participated in Calibration of the analytical instruments and equipment.
  • Performed quality test - Tablet disintegration and dissolution tests, hardness, API concentration determination.
  • Participated in preparation of validation plan.
Affiliations
Compliance and Documentation, Sampling techniques for Cleaning & process Validation, Risk Assessments & Mitigation, HVAC Design, Operation, Troubleshooting, Aseptic Processing, Design of Experiments, Pharmaceutical Facility Design, Computer life cycle management. *Formulation and development of different Pharmaceutical dosage form including tablets, Calibration of equipment, cleaning validation, swab sampling. Risk Assessment - Fish bone (Ishikawa) diagram, Root cause analysis, Process Validation, Familiar with operations and tooling of tablet punching machine, Tablet Evaluation Equipment, Autoclave, Incubator, Analytical Techniques- Operated various equipments like High Performance Liquid Chromatography (HPLC), TOC analyzer, UV visible spectrophotometer, bioreactor cell culture.
Education
Expected in MS | Pharmaceutical Manufacturing Engineering Stevens Institute of Technology, Hoboken, NJ GPA:
Pharmaceutical Manufacturing Engineering
Expected in Introduction to Pharmaceutical Manufacturing, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, GMP in Pharmaceutical Facility Design, Project Management, Quality in Pharmaceutical Manufacturing, Lean Six Sigma in Pharmaceutical Manufacturing, Manufacturing and Packaging of Pharmaceutical Oral Solid Dosage Products, contemporary concepts of validation. Process analytical technology, Quality by design | , , GPA:
Expected in MS | Biotechnology Lovely Professional University, , Punjab GPA:
Biotechnology
Expected in BS | Biotechnology North-eastern Hill University, Shillong, GPA:
Biotechnology

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School Attended

  • Stevens Institute of Technology
  • Lovely Professional University
  • North-eastern Hill University

Job Titles Held:

  • Validation Engineer
  • Validation Engineer & Teaching Assistant
  • Product Specialist

Degrees

  • MS
  • Introduction to Pharmaceutical Manufacturing, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, GMP in Pharmaceutical Facility Design, Project Management, Quality in Pharmaceutical Manufacturing, Lean Six Sigma in Pharmaceutical Manufacturing, Manufacturing and Packaging of Pharmaceutical Oral Solid Dosage Products, contemporary concepts of validation. Process analytical technology, Quality by design
  • MS
  • BS

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