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Process Engineer Resume Example

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PROCESS ENGINEER
Professional Overview
Bioprocess Manufacturing and Process Development Engineer 9+years of Industrial experience as Process Engineer in Bioprocess and vaccine development/cGMP manufacturing process.
Summary of Skills
Filtrations systems (TFF, UF/DF) * Identification cGMP requirement for regulatory Inspections * Sterile filtrations &single use systems * Working cross-functionally with QA/QC and RA departments * Chromatographic separations (SEC, HIC and Affinity) * Knowledge of safety according to OSHA regulations.
Education
Bachelors of science : Biotechnology, 2004Sri Venkateswara UniversityBiotechnology
Masters of Science : Biotechnology, 2006Biotechnology Bangalore University India Biotechnology
Professional Experience
Process Engineer
March 2012 to CurrentJN International Medical Corporation － Omaha, NE
  • Working as Process development engineer for development of Meningococcal meningitis conjugate vaccine, for serogroups A/C/Y&W-135.
  • Handled vaccine production activities including Master and working cell banks preparation, bacterial growth media optimization, seed development, fermentation process, purification of polysaccharides and conjugation of polysaccharide with carrier protein for use in final vaccine preparations.
  • Conducted pilot and production scale fermentation of clinically important bacterial cultures and biosafety level 2 organisms.
  • Inform Process Development decisions with respect to facility fit and the manufacturability.
  • Providing Process Development with the information required to develop fit for Suite/Site processes (i.e.
  • raw material preferences, standard procedures, preferred operating methodologies.
  • Interact regularly with Manufacturing technicians, Manufacturing Science department, automation engineers, Validation and Quality, Lead support in data trending for process improvements and issue resolution.
  • Author, review, and approve change controls, deviation investigations (NCEs), standard operating procedures (SOPs), batch records, work orders, etc.
  • Participated in the manufacturing of meningitis conjugate vaccine for immunization against serogroups A/C/Y&W-135 for use in Phase-3 clinical trials.
  • Development of Diphtheria toxoid for use in conjugation process as a carrier protein.
  • DT polishing process to remove glycan impurities using HIC chromatography Executed microbial culturing using aseptic handling; Handling polysaccharide production and purification of meningococcal polysaccharides and have strong expertise in endotoxin removal techniques and column chromatography; Qualified and trained to handle microbial pathogens such as meningococci, pneumococci, salmonella and diphtheria.
  • Responsible for Good documentation practices, Document control system; Change control, Validation support; Personnel training program, Supplier qualification, Raw materials & product inventory management, Internal and external auditing.
  • Oversight of Environmental Monitoring Program, Oversight of manufacturing process validation, and works in tandem with QC and regulatory departments.
  • Upstream & Downstream Processing: Developed in-house bacterial growth medium for culturing meningococcal bacteria and Diphtheria.
  • Optimization of fermentation process enabled with SCADA system with 21CFR compliance, growth curve determination, Batch mode process, determination of harvest time, optimizing fermentation parameters and fermentation process validation activities, Harvest, Inactivation and upstream processing steps for isolating polysaccharide from host cell impurities.
  • Downstream process development and product purification.
  • Hands-on experience with set-up, operation of equipment used in downstream processing, Enzymatic treatment for removal of contaminating proteins and nucleic acids to obtain purified polysaccharide.
  • Ultra-diafiltration (UF/DF) and TFF systems, Ultracentrifugation and sartobind Q filtration for endotoxin removal.
  • Experienced and Qualified in BSL II lab and clean room environment.
  • Chromatographic methods Include (SEC and Hydrophobic interaction) Handed Chemicals used in manufacturing process and their disposal.
  • Experienced in qualification, validation of downstream purification Process and related Equipment systems.
  • Conjugation: Technical expert in the bacterial vaccine process including preparation of Polysaccharide-protein conjugates and troubleshooting non-conformance occurrences in manufacturing.
  • Knowledge of protein-polysaccharide chemistry, conjugation chemistry, Polysaccharide-protein activation methods, conjugation methods, reductive amination, and polysaccharide-protein conjugate purification.
  • Performed and lead investigations required for the completion of project.
  • Validated and performed serum bacterial assay on Phase-II clinical trial samples, experienced in handling "ProtoCOL3" automated colony counting system.
  • Wrote and maintained documentation of work performed as per cGMP requirement.
  • Followed Compliance with all lab Safety requirements and procedures.
  • Implemented cGMP regulations, worked on process validations, in process Quality system design.
  • Deviation management, CAPA implication, change controls and process troubleshooting support.
  • Manufacturing Executive and Quality Compliance.
January 2012 to CurrentJN-International Medical Corporation － Omaha, NE
  • Summary of skills Core Industrial experience in Biologics/Biopharmaceutical and vaccine manufacturing process, Expert knowledge in Process design, development, Fermentation process, Upstream/Downstream processing Purification, executing process validations required for vaccine manufacturing process, Assures consistency of manufacturing process - Technology transfer/ Reproducibility of process design evaluated commercially - Provides assurance of commercial readiness, validation activities, risk assessment evaluating at all manufacturing steps and tech transfer process.
  • Writing validation master plan, Technical writing, summarizing results, data analysis and Facilitate corrective and preventative action completion by leading cross-functional teams through root cause identification and corrective action determination exercises.
  • Experienced in investigating deviations and drive continuous quality improvements.
  • Deviation reporting and closure support, Management of CAPA's and Change Controls to ensure due dates are achievable and actions are consistently completed on time.
  • Worked on Bacterial vaccines development, which includes production of Bacterial polysaccharide conjugate vaccines like Meningococcal meningitis polysaccharide conjugate vaccine, Haemophilus Influenzae type b conjugate vaccine, Typhoid Vi-capsular polysaccharide and Vi-Polysaccharide -Tetanus toxoid conjugate vaccine and development of Diphtheria toxoid and Handling mammalian cell cultures.
  • for development of Meningococcal conjugate vaccine, currently working on manufacturing of Clinical trial material for use in Phase-III Trial.
  • Preparing facility to adhere cGMP compliance, working on preparing protocols and executing cleaning/process validation activities.
  • Processing lot-lot consistency batches.
  • Providing daily on-the-floor technical support and technical leadership in process failure and related investigations.
  • Developing strategy for process validation activities.
  • Maintaining the Process Control Strategy and Operating Control Strategy.
  • Identifying and implementing commercial process/product life cycle improvements.
  • Defining relevant operational/technical standards and practices for the site.
  • Support large and small projects deemed important to the safety, quality, efficiency and effectiveness of the bacterial antigen production facility.
  • Provide operational input regarding new equipment and process changes.
  • Serve as a scientific and technical interface with suppliers of equipment and materials.
  • Handle Process Validation, Technical Transfer to cGMP Operations, Risk analysis generation, Product/Buffer/Medium Hold Times, process equipment's qualification and validations, ensure compliance on leachable / extractable, Container Closure.
  • Ensure Stability of product at the various stages of the process, Filter Integrity testing systems.
  • Identification of Non-conformances in production process and facilitation of interdepartmental process improvements.
  • Utilize root cause analysis techniques during deviation investigational process Work cross functionally, to develop and implement continuous process improvements Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
  • Qualified to write, review and author SOP, s, MPCR, BPR, process/cleaning validation protocol generation, Master validation plan Ensure and promote compliance with applicable cGMP regulations as per company SOP, s/Provides Quality GMP oversight at Biologics manufacturing facility.
  • Available for guidance and answer questions by providing 'on the floor' support during all aspects of manufacturing.
  • Support timely closure of batch records including Batch records and Release of Product as needed Review and comment on open Deviation Reports to improve documentation of incidents and support timely closure of reports.
  • Develop preventative measures to avoid recurrence as appropriate, Support the qualification of the Biologics equipment and facilities and systems for the Biologics manufacturing.
  • Assist in the generation of Annual Product Reviews.
  • Review documents such as protocols, reports or any other controlled document.
  • Expert knowledge in handling upstream fermentation process, scale up studies, pilot and production scales using stainless steel fermenters via SCADA system, Handled Sartorius BIOSTAT D-DCU and Bioengineering fermenters (10, 20, 50 & 150L scale fermenters) centrifugation devices, chromatography skids and Dialysis process, TFF, UF &DF filtration systems, Depth filtration, Ultracentrifugation, IEx, SEC, Affinity and Hydrophobic Interaction chromatography.
  • Sartobind Q filtration.
  • Practical exposure to cGMP regulations, Process Optimization, and Validation and comparability studies required in vaccine manufacturing.
  • Developed and implemented Standard Operating Procedures (SOPs), Manufacturing protocols, and maintained records and logbooks of all equipment as per current Good Manufacturing Practices (GMPs).
  • Practical knowledge of CMC sections specifically in process validations, risk assessment, knowledge of technical writing and regulatory filling experience.
  • Co-ordinated with Quality Control and Quality Assurance for deviations, change control, batch production records, updating process requirements and product change over requirements.
  • Evaluate process development requirements, equipment status, solutions, materials and processes by reviewing the pertinent records and Monitored processes to identify opportunities for continuous improvement for good productivity.
  • Associated with Quality system teams and played key role in WHO an USFDA regulatory audits.
December 2006 to February 2012Bharat Biotech International limited － Hyderabad, India
  • Perform record review of all production-related records to ensure compliance with applicable Standard Operating Procedures, Current Good Manufacturing practices.
  • Maintain Quality records per Standard Operating Procedures.
  • Initiate and support investigation of any non-conforming events (NCE) identified during record review.
  • Support of CAPA investigations and plan implementation.
  • Support of Complaint investigation and report generation.
  • Support the Document Control process as needed.
  • Review and maintain equipment calibration and preventive maintenance documentation and cleaning validation protocols.
  • R&D Expertise- Worked as Executive in R&D, scale up and manufacturing process for development Polysaccharide conjugate vaccine, Development of Haemophilus Influenzea type b vaccine and Typhoid Vi-capsular polysaccharide and Vi-Polysaccharide-Tetanus toxoid conjugate vaccine, also worked in mammalian cell culture vaccine production for manufacturing of rabies vaccine using Vero cells.
  • Handled scale up of upstream, downstream and conjugation processes.
Accomplishments
  • Upstream & Downstream Processing- Preparation of medium (MEM), Preparation of working Cell Bank (VERO Cells), Cell splitting and scaling up of cells, Virus infections, Viral Harvest and Clarification, Purification of virus, Inactivation of virus, Handling of Cell Stacks (1to 40 layers), Media & solutions preparations, Scaling up of Vero cells, Affinity, IEx Chromatography, Membrane UF/DF and sterile Filtration techniques.
  • Culture media Optimization-Synthetic media, Veg-media for production form animal source free vaccines.
  • Fermentation Studies-Batch and fed batch mode process, Optimization of Parameters like pH, Dissolved oxygen (DO) requirement, Supplements, Growth Kinetics, Culture Inactivation.
  • Cell separation, Hexadecyltrimethylammonium bromide treatment, Deoxycholate (DOC) treatment for removal nucleic acid, removal of Lipo-polysaccharide, Ultrafiltration, Sterile filtration techniques, Isolation of purified Poly ribosylribotolphosphate(PRP) and Vi-capsular polysaccharide removing other host cell impurities.
  • Development of conjugation methodologies- PS Activation, size reduction, carrier protein modification, cynalation, PS-Pr coupling methodologies, Chromatographic Columns (GPC)-For Purification of polysaccharide-protein conjugates, conducted vaccine challenge study in Mice models.
  • Identification of Strains- Revival of Haemophilus Influenzae type b strain.
  • Colony morphology, Microscopy Examination for checking purity, Grams staining, Agglutination with Hib type b antiserum, X&V factor requirement test, Oxidase reaction, Catalase reaction, Glucose Fermentation, Sucrose Fermentation, Lactose Fermentation.
  • Master cell bank and Working Cell Bank Preparations.
  • Publication Venkatesan R*, A.
  • Praveen Kumar and V.K.
  • Srinivas.2011.
  • A challenge study to assess the protective efficacy of typhoid Vi-Polysaccharide-protein conjugate vaccine in laboratory animals.
  • INT J CURR SCI 2011, 1: 45-4 http://www.currentsciencejournal.info/issuespdf/99_nov6.pdf Skills cGMP manufacturing, DOE, Process validations.
  • Bacterial fermentation process, mammalian cell culture, polysaccharide-protein conjugation chemistry, cleaning validations, clinical trial manufacturing, continuous process improvement, data analysis, UF/DF, TFF Dialysis process, Documentation control, Downstream processing, purification, chromatography methods (IEx,SEC,HIC and Affinity), Endotoxin removal techniques.
  • Internal and external auditing experience, CMC knowledge and regulatory filling, Practical knowledge of regulatory compliance 21CFR Part 211 and ICHQ7,Good Laboratory Practices, immunization, inventory management, manufacturing process, materials, works, Process optimization, Personnel training, process design, Process development, SOP's, MPCR,BPR protocols preparation and execution, Quality Control, Quality Assurance, requirement, risk assessment, Safety, SCADA, SOP, system design, tandem, technical writing, process troubleshooting and supervisory experience.
Skills
approach, automation, Biotechnology, BPR, C, calibration, cell culture, chemistry, cleaning validation, clinical trials, continuous improvement, data analysis, Dialysis, documentation, Downstream, engineer, external auditing, filling, functional, GMP, immunization, inventory management, leadership, manufacturing process, materials, works, Optimization, Personnel training, Process Control, Process design, Process Development, processes, process equipment, protocols, Quality, QA, Quality Control, Quality Assurance, reporting, requirement, Risk analysis, Risk assessment, Safety, SCADA, scientific, SOP, Strategy, system design, tandem, technical support, Technical writing, troubleshooting, type, Upstream, vaccine, vaccines, Validation, Vi, Author
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Resume Overview

Companies Worked For:

  • JN International Medical Corporation
  • JN-International Medical Corporation
  • Bharat Biotech International limited

School Attended

  • Sri Venkateswara University

Job Titles Held:

  • Process Engineer

Degrees

  • Bachelors of science : Biotechnology , 2004
    Masters of Science : Biotechnology , 2006

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