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Engineer Manufacturing

Location:
Hyderabad, Telangana, India
Posted:
October 25, 2018

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Resume:

Karthik

818-***-****

ac7h2a@r.postjobfree.com

Summary:

A Validation professional experienced in Pharmaceutical and Medical device industries with focus on Commissioning & Qualification (C&Q) of lab and manufacturing equipments with strict adherence to GAMP &cGxP regulations (cGMP, GLP, and GCP).

Superior knowledge of GAMP, CFR 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails.

Knowledgeable of cGMP, CFR's, ISO, ICH guidelines applicable to Drug Product, Drug Substance and Combination Product manufacturing.

Experience performing GAP Analysis, Complaint Investigations, Supplier Qualification.

Internal and External Audit management, Deviation Management, Data Trending, Change Management and Training/Certification.

Experience includes roles in Quality Control, Production, Research & Development and Quality Assurance with domestic and international pharmaceutical and medical device manufacturers.

Skilled at driving to root cause through comprehensive and thorough investigations utilizing process and risk based management tools resulting in effective corrective and preventative actions.

Detailed understanding of the Quality Assurance process with respect to system compliance.

Experienced in developing SOPs and User Manuals in preparation to support the production systems.

Expertise in development and modifying documents related to Lifecycle Documentation such as Validation Master Plan (VMP), User requirement specification (URS) Functional requirement specification (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Configuration Management, Validation Summary Report (VSR), Test Summary Report, Periodic review report, designing Requirement Traceability Matrix (RTM), Deviation Reporting, Design Specification (DS), Source code Review (SCR), Risk Assessment, Business continuity plan (BCP), Disaster recovery plan(DRP), Change Control, and Incident etc.

Knowledgeable in domestic and international regulatory requirements for Medical Devices, combination Device/Pharma, MDD, 21CFR part 11, 801, 812, 814, 210, 211)

Proficient in reviewing and documenting validation protocols like Performance Qualification (PQ), Operational Qualification (OQ) and Installation Qualification (IQ) protocols.

Performed Test Method Validation (TMV's) for Medical devices, Receiving Inspection and Return products analysis Labs.

Collaborate with QA/RA on validation activities in preparation of pending regulatory submissions (PMA), and follow-on audits.

Proficient in performing CAPA Analysis and writing Remediation Plans.

Experience working with and validation of Laboratory Information Management System (LIMS), Track Wise, Change Control Management System (CCMS), Adverse Event Reporting System (AERS) Spreadsheet and Report Validation.

Performed various boundary tests as well as data validation to ensure record retrieval and search engine tests.

Extensive experience in ALM (Application lifecycle management) and Quality center.

Excellent Knowledge in Leading, Design and Implementation of Quality Management System.

Validation of COTS Software and Vendor Assessment.

Good Knowledge of MS-Project, HP Quality Center and MS Visio.

Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and as a part of team.

Technical Skills:

Computer System Validation

21 CFR Part 11 (210/211, 814, 820), GAMP, cGMP, GDP, GLP, IQ, OQ, PQ, RTM, SOPs

Testing Tools

HP Quality Center, ALM

Business tools

MS Office (Word, Excel, Power Point, Access, Visio), TrackWise 7.0, Siebel CRM, LIMS, ServiceNow, Documentum and GDocs.

SDLC

Waterfall, V-Model, Agile

Operating Systems

Windows NT/95/98/2000/XP/Vista/7

Instrumentation

Packaging lines, Manufacturing modules, Autoclaves, Incubators, TOC, Labeler, Tray Sealer, HPLC and FTIR, UV spectrophotometer etc.

EDUCATION:

Masters in Manufacturing Engineering from California State University, CA

PROFESSIONAL EXPERIENCE:

BMS, Devens, MA Jul 2018 – till date

Manufacturing Engineer

As a Manufacturing Engineer, performed commissioning and Qualification (C&Q) of manufacturing equipments and the auxiliary systems. Primary responsibilities include:

Involved in the development and execution of validation protocols like Site Acceptance Testing (SAT) and IOQ for manufacturing equipment’s and packaging lines.

Collected Design requirements (DR) and develop Design Qualification (DQ) protocols in addition to IOQ protocols for the systems like - WFI Generation, Storage and Distribution System; Carbon Dioxide distribution system; Nitrogen Distribution system; Clean Air distribution system.

Developed and executed IOQs onPrimary Packaging lines, Manufacturing Modules, HEPA filters etc.

Performed Equipment Change Process (ECPs) for Steris Parts Autoclaves, Sterilizers, HPLCs, Autoclaves etc.

Executed IOQ protocols for Refrigerators, Incubators, Sterilizers, HPLCs, Autoclaves etc.

For the Analytical labs supporting production, perform Temperature mapping using Data Collectors/ Kaye Validators.

Followed change management processes, ensuring adherence both internally and by equipment manufacturers.

Developed Amendments, Addendums and Software Gap Assessments etc. as a part of protocol executions.

Developed and maintained Traceability Matrix to match IOQ test cases to the User/Design requirements.

Reviewed Operational Qualification protocol for equipment related SOPs and functional specification verification.

Investigated and resolved deviations incurred during execution of protocol documents.

Based on CAPA assessments, ensured elements identified were fully validated within the qualification protocols.

Verified continuously if the operators are cleaning the equipment and vessels as per the protocol.

Verified that all equipment and processes are properly configured prior to manufacturing.

Supporting for system configuration and creating new system configuration.

Zimmer Biomet Inc., Warsaw, IN Jan 2017 – Jun2018

CSV Engineer

As a CSV Engineer, performed Commissioning and Qualification (C&Q)Laboratory equipment. Some of the key responsibilities in developing and managing validation deliverables are as below:

Prepared, revised, and implement IQ, OQ, and PQ validation protocols and reports according to GMP guidelines, ensuring execution and documentation of the qualification process for the laboratory equipment to include GC, HPLC, UV-Visible spectrometer, TOC Analyzer, ICPMS, and dissolution.

Supported lab operations team by preparing technical documents such as SOPs, qualification protocols, change controls, periodic reviews.

Drafted and executed Qualification and Re-Qualification protocols for the analytical Equipment such as HPLC, GC, UV-Visible spectrometer, TOC Analyzer, ICPMS.

Performed duties such as up keeping of the laboratory, equipment maintenance, calibration and troubleshooting, and procurements, record keeping, supporting the day-to-day running of the laboratory.

Provided compliance support for instrument lifecycle management.

Maintained compliance requirements for established instrumentation in the lab as well as incoming instrumentation.

Worked in a cross-functional team to support lifecycle qualifications, commissioning, and decommissioning of instruments and equipment in the laboratory.

Performed all duties per cGMP requirements with the ability to follow written SOPs and compendia procedures.

Involved in Laboratory utility management and procurement of MilliQ and distilled water, compressed gases such as compressed air, Nitrogen etc.

Provided support for investigations as needed.

Performed temperature mapping by Kaye Validator 2000 for performing temperature mapping of controlled temperature units including freezers, refrigerators, and incubators.

Coordinated with lab ops team to provide support and documentation for new equipment and instruments to laboratory staff.

Maintained a high level of error free, GMP compliant documentation.

Used Microsoft-based Office applications for report writing.

Used EDMS (glorya) for the control of documents.

Interacted with appropriate departments and individuals to accomplish work independently.

Involved in maintenance of LIMS database, training, data archrivals, daily backups and retrievals.

Ensured each sample in the Retention and Stability programs had the proper lifecycle.

Ensured effective implementation of Good Laboratory Practices as per the applicable regulations as well as the company policies, guidelines, and procedures.

PRA Health sciences, Raleigh,NC May 2016– Dec 2016

Validation Engineer

As Validation Engineer, responsible for developing CSV deliverables for Laboratory equipments. Some of the key responsibilities are as follows:

Overall performed remediation and validation of legacy and new computer systems of laboratory equipment (like Autoclaves, centrifuges) - GLP and GMP assessments, GAP assessments, writing validation plans, user requirements, functional specifications, IQ, OQ, PQ and summary reports.

Involved in collecting Business requirements and working with equipment vendors in delivering equipments that meet company policy and FDA regulations.

Performed GAP analysis on current lab equipment and reported to the IT and Business owners.

Assessed CAPAs and implemented process elements based on findings.

Developed validation IO/OQ, PQ protocol templates for new lab equipments.

Authored and executed IQ/OQ, and PQ, protocols. Authored and executed IOQ protocols for Autoclaves, Bioreactors, Lyophilizers, and Parts Washers, laboratory instruments (HPLC, UV-Visible Spectrophotometer, and Osmometers).

Wrote test method validation protocols for various printed circuit board inspection equipment.

Wrote and developed test method validation protocols used for moisture analysis.

Assisted in developing a test method template for future validation requirements.

Executed Test Method Validation Protocols and wrote Test Method summary reports.

Prepared validation summary and test method summary reports.

Thermo Fischer, Carlsbad, CA Jul 2014 to Apr 2016

Jr. Validation Engineer

As a Validation Engineer, played an active role on qualification, QC testing, calibration mechanism etc. for wide range of Analytical lab equipments.

Performed analytical testing on raw materials, intermediates, and APIs in support of GMP production, process research, and stability projects.

Coordinated receiving, tracking, sampling and testing of raw materials.

Conducted QC testing using analytical laboratory instrumentation: HPLC, UPLC, GC, UV-Vis, Karl Fischer, FT-IR, Moisture analyzer, pH meter, and Refractometer.

Microbiological monitoring of air & Environment, Perform Stability Testing and Cleaning Validation.

Supported production with routine analysis of in-process samples.

Completed and reviewed GMP data for GDP errors and inconsistencies.

Performed Environmental Monitoring of facilities using air samplers and particle counters.

Performed monthly calibrations on analytical laboratory equipment and instrumentation.

Performed Growth Promotion of media and Bioburden testing.

Taking Corrective actions in case of deviations and OOS.

Maintain compliance with occupational safety and health, especially regarding hazardous materials and waste.

Prepared, Reviewed & updated SOPs to ensure compliance with regulations and current practices.

Actively participated in new initiatives involving Lab topics.

Developed and performed Method validations & Calibrations of Equipment.

Served as raw material subject matter expert for newly implemented LIMS.

Created, as well as reviewed HPLC and GC methods within LIMS.



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