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Engineer Manufacturing

Location:
Hyderabad, Telangana, India
Posted:
April 06, 2018

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Resume:

PROFESSIONAL SUMMARY:

Over *years of experience as an Equipment Commissioning, Qualification, Cleaning and Process Validation Engineerin compliance with FDA (21 CFR Part 11,210,211) and ISO standards in Health care and Pharmaceutical Industry.

Involved in the Life Cycle Development process for Prospective, Concurrent and Retrospective validation.

Good practical knowledge on Life Cycle Development protocol which includes Commissioning, Qualification, Revalidation and Decommissioning protocols.

Executed and reviewedvalidation protocols(IQ, OQ, PQ) and SOP’sfor Commissioning, Qualificationand the cycle development process.

Performed and executed Validation, Qualification and Re-Qualification protocols for the Manufacturing Equipment.

Validated equipments such as Autoclave, Heat Bar Sealer, Label Matrix, VWR Incubator, RDN Cutter Machine and UNIVERSAL Pin Wire Driver for Surgical manufacturing facility.

Experience in Cleaning validation (COP and SIP).

Generate Final Reports.

Riboflavin (Spray coverage testing).

ReviewedValidation Master Plan (VMP) as well as Validation Summary Report (VSR) for process lines and cleaning process.

Experienced in reviewing User Requirement Specifications (URS), Design Specifications (DS) and reported Functional Requirement Specifications (FRS).

Experience in temperature mapping of equipment’s usingkaye validator.

Validated production processes: Extrusion, Molding Sealing, Assembly and Packaging for Surgical manufacturing facility

Expertise in performing and reviewing risk assessment usingGap Analysis and CAPA and suggested Remediation Plans to mitigate the non-compliance.

Very good understanding of P&ID diagrams.

Good knowledge of GxP’s (CGMP, GLP and GCP), ICH guidelines.

Possesses excellent written and verbal communication skills with strong abilities in requirement capture, analysis, design and development.

PROFESSIONAL EXPERIENCE:

Genentech, OR Nov 2016- Dec 2017

Validation Engineer

Perform commissioning & qualification project engineer responsibilities during the procurement, installation and implementation.

Performed FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) for equipment using in the production.

Reviewed the test cases and dry run them for completing the validation cycle.

Authoredvalidation documents independently such as OQ and final summary report for the qualification.

Involved in Operation Qualification using thermocouple calibration and Temperature mapping of equipment like autoclaves, TOC, incubators, freezers, refrigerators, ovens.

Experience in documentation of various documents like Validation Master Plans (VMP), Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualification (PQ), incident reports if any, CAPA's and Validation Summary Reports (VSR)

Involved in Commissioning &Qualification/ Validation processes and related documents to standardize and improve compliance, decrease cost and creates value for the company.

Development and execution of commissioning protocols for Incubators, Freezers, Tanks, Chromatography Columns, Lyophilization, Autoclaves and equipment during Start-up project.

Verified commissioning documentation was adequate to perform IQ testing and met corporate requirements.

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

Responsible for inspecting equipment in the regulated pharmaceutical sector in accordance with GXP systems.

Ensured complete 21CFR part 11 compliance assessments for manufacturing systems.

Root Cause Analysis with Design of Experiments to drive out variation in test equipment.

Zimmer Biomet, IN May 2015 – Nov 2016

Validation Engineer

Responsibilities:

Created and executed multiple Protocols (IQs, OQs, and PQs) and generated Validation

Summary Reports (VSR) to summarize the overall validating effort as per FDA regulations and company standards.

Validated production processes: Extrusion, Molding Sealing, Assembly and Packaging for Surgical manufacturing facility.

Validated equipments such as Autoclave, Heat Bar Sealer, Label Matrix, VWR Incubator, RDN

Cutter Machine and UNIVERSAL Pin Wire Driver for Surgical manufacturing facility.

Reviewed and approved multiple protocols (IQs, OQs, and PQs), SOPs, deviations reports and document changes through the Change Control processes for accuracy and completeness.

Participated in the preparation and revision of risk assessments using tools such as Process/Design

Failure Mode and Effect Analysis (PFMEA/DFMEA).

Established and revised Standard Operation Procedures (SOPs) for production equipments,

Manufacturing processes and Quality processes; Trained production operators.

Reviewed and developed Technical Reports and System Specification for new and existing

Disposable and Capital products at Zimmer Surgical.

Handled day to day Quality Issues in department: Molding, Extrusion, Irrigation, Hemovac and Packaging.

Supports improvements by Root Cause Analysis of Non-conformances. Tracks and

trend all Non-conformances and Supplies Weekly Metrics.

Verified the Reproducibility and the Repeatability of existing processes and gages through Variable

and Attribute Test Method Validations.

Reviewed and established Feature Verification Plan (FVP) and Product Inspection Plan (PIP)

for Zimmer Biomet Surgical products.

Investigated and produced summary reports for Nonconformance and Health Hazard Evaluation.

Initiated and investigated Corrective and Preventive Actions taken for nonconformance.

Generated Notification of Gauge Out of Tolerance (NGT) reports and analyzed if Validation and Products Quality Affected by the NGT.

Performed Statistical Analysis of all OQ/PQ/TMV/Monthly Metrics/Capability Analysis results

and created reports using Minitab.

Aurobindo, Hyd Mar 2014- May 2015

Validation Analyst

Responsibilities:

Perform riboflavin spray coverage testing for all vessels and COP.

Generate/execute cycle development protocols and final reports for COP.

Perform visual inspection, swab and rinse samples for all COP process.

Perform manual/process soiling parts for COP part washers for cycle development and PQ runs.

Execute PQ protocols for CIP circuits and COP.

Perform Dirty and clean hold time studies for cycle development and PQ.

Ensure all Validation activities are conducted in compliance with cGMP, company policies, safety standards and applicable SOP’s.

Generate Job Aids (SOP) for COP loads.

Design load pattern for all COP Loads.

Coordinate with other departments and consultants for validation activities.

Train manufacturing personnel to run CIP and taking rinse samples.

Work in COP and manual cleaning validation activities (Manual Washer and Ultrasonic) for cleaning tools, gaskets, hosebarbs, bleedvalves, rotors, impellers etc.,

Determined sampling and analytical methods for recovery and detection of residues swab/rinse.

Developed the cleaning method and analyzed the samples for TOC, Endotoxin, conductivity and bio burden.

Reviewed protocols and cleaning procedures to ensure that everything is on place prior to execution.

Experience in preparing manufacturing batch records and other paperwork related to the production process and ensures accuracy.

Determined the cleaning methods, agents and came up with Acceptance Criteria for residuals.

Performed Verification of COP process through Visual Inspections using Riboflavin and UV light for identifying Particulate matter in pharmaceutical solutions.

Responsible for daily reports of status updates, department communication, document tracking and reporting results to management through daily meetings.

Compile required data using PI and perform data analysis as required per validation protocols.

Analyze PI trends to define recipe parameters (flow rate, path clean time, conductivities, etc.) for CIP cycle development.

Established document evidence at high degree of assurance, specifications and quality attributes.

Gland Pharmaceuticals, Hyderabad, India Oct 2012 - Feb 2014

Validation Specialist

Responsibilities:

Developed and executed commissioning protocols for Incubators, Freezers, Tanks, Chromatography Columns, Lyophilization, Autoclaves and equipment during Start-up project.

Responsible to evaluate, write and close the incidents and deviations that arise during protocol executions.

Involved in commissioning, Qualification and validation of new insulated portable vessels.

Prepared, executed and documented Design Qualification (DQ) protocol and final report for Vessels.

Involved in identifying cleaning methods and agents used for cleaning, developed acceptance criteria for residuals and degree of evaluation required to validate the process.

Involved in development of sampling methods such as swab, rinse, HPLC, dry residue etc., for the detection of residues.

Involved in commissioning and Validation of process equipment in large scale which are used for pharmaceutical product. This equipment includes Vessels, Blenders, tablet press, granulators, dryers etc.

Performed component material selection through the usage of package integrity test methods.

Performed label adhesion testing on small diameter glass packages within multiple test environments.

Authored SOP’s, summary reports for validation and verification.

Involved in development of IQ, OQ and PQ for automated CIP skids (used for equipment such as tanks, Spray dryers)

Collected all the supporting documents (URS, FRS) for preparation of VMP, SAT and Risk Analysis. Involved in authoring VMP, SAT and IOQ’s for different equipment.

EDUCATION

Bachelor of Pharmacy – Pharmaceutical sciences

JNTU, Hyderabad, India

Master of Pharmacy

JNTU, Hyderabad, India



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