Summary
Overview
Work History
Education
Skills
Timeline
Generic

Rudra LLC - Candidate 01

Columbus,OH

Summary

Experienced Validation Engineer with background of Commissioning and Qualification (C & Q),
Temperature Mapping, Sterilization Validation, Cleaning Validation & Process validation in areas of
Pharmaceutical/ Biopharmaceutical industry.

Overview

5
5
years of professional experience

Work History

Cleaning Validation Engineer- Onsite (Freelancer.)

Hikma Pharmaceuticals (Boehringer Ingelheim Subsidiary)
09.2023 - Current
  • Revised and updated Cleaning Validation documentation including Validation SOP, Functional Risk Assessment, Validation Project Plan and Cleaning Validation study protocols.
  • Support the optimization of processes including manual and automated cleaning processes.
  • Support the development of cleaning activities to ensure that the system’s validation state is maintained.
  • Designing and authoring technical protocols and reports in alignment with the philosophy defined by the Cleaning Validation engineering team.
  • Compile cleaning verification and validation data, investigations, and change control information for technical reports related to the cleaning program.
  • To ensure policies, procedures, and practices keep systems/processes in good standing and in a validated state.
  • To document and maintain the validated state of cleaning processes.
  • Supporting life cycle implementation of new detergents, new CIP systems, and process improvement.
  • Keeping abreast of industry trends and expectations from corporate requirements and regulatory agencies.
  • Maintaining cleaning validation program consistent with current requirements.
  • Conducting meetings with internal and external groups to outline expectations.
  • Evaluation of equipment for sample locations using multiple criteria including product properties which impact cleaning, equipment usage, site sampling ease.
  • Ensure documents/systems are aligned to decisions.
  • Authoring technical documents/reports using approved templates.
  • Using Technical skills and attention to detail to ensure quality of data and thorough analysis.
  • Using knowledge of cleaning and cleaning validation requirements to ensure requirements of the protocol are met.
  • Executed TACT time, Dirty Time hold & Clean time Hold Protocols for pharmaceutical & bio-pharmaceutical equipment.

CSV/CQV Validation & Compliance Engineer- Onsite (Freelancer.)

Minaris Regenerative Medicine
01.2023 - 09.2023
  • CSV life cycle documentation - Validation Determination, URS User Requirements, Master Plan, Validation Protocol, Validation Plan, Risk Assessment, Test Cases, Final Validation Summary Report, Validation Release, Retirement reports
  • CQV commissioning of general equipment such as Refrigerators, Incubators, Centrifuges, Biological safety cabinets, liquid nitrogen freezers, ultracold freezers, Balances, and Tube sealer.
  • Looking over team responsible for temp/humidity mapping of the equipment, warehouses, cold rooms, etc.
  • Entail periodic review involving reviewing calibration/certification reports, deviation reports, qualification protocols, and look for any deficiencies that require mitigation and validation of HVAC systems.
  • Performed Data Integrity Gap Assessment for simple systems and computerized lab instruments which are connected to network.
  • Involved in all Global DI meetings and report DI activities to Global CSV manager as a CSV specialist.
  • Created remediation plans for the gaps that were identified through gap assessment.
  • Developed user access memo with users list and assigned roles to the users in the systems.
  • Updated DI remediation Tracker every month and making sure all remediation are closed within the due date.
  • Reviewed and Updated Validation SOPs as needed in VEEVA.
  • Drafted Audit Responses for all Observations regarding Data Integrity for Laboratory instruments.
  • Worked with Analytical and Micro team in generating User requirements specifications and Design Specification for all laboratory instruments.
  • Reviewed System Impact Assessment which determines the overall system risk and system GAMP categorization.
  • Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR part 11.
  • Drafted and Executed Computerized Qualification protocol for Unicorn Software, Tiamo Software and Cipher Software and Distek 2500 and 5300 Dissolution Systems, drafted Nonconformance report that was identified during qualification.
  • 21 CFR Part 11 and Data Integrity, Change control, Periodic reviews, validation project lead, engineering documents, audits and inspections etc.

Systems Validation Engineer- Onsite (Contract)

Boehringer Ingelheim Pharmaceuticals
01.2022 - 01.2023
  • Preparing and executing Validation and (IQ), (OQ), (PQ) for process equipment such as autoclaves, Roller mixers, Bioreactors, Tanks, Refrigerators, Skids, Centrifuge, Freezers/Ultra-low freezers and Lyophilizers in compliance with cGMP and FDA regulations etc
  • Microbial and particulate monitoring test and filter integrity testing etc
  • Automation: DCS Emerson DELTA-V/ Siemens PCS7, PLC, SCADA etc
  • FAT, SAT, Commissioning for different utilities.
  • Authoring as SME-Subject Matter expert for Change Control, Risk Analysis, Traceability Matrix, Deviation, Project management, Commissioning documentation etc
  • Sourced new manufacturing and laboratory equipment for testing and usage.
  • Working with Quality and Manufacturing with Non-Conformances and disposition activities.
  • Writing DQ/IQ/OQ/PQ protocols for facilities and utilities as well as related software (GAMP5, ISO, GAMP, ALCOA, Data Integrity, FDA Annex 11).
  • Automation (PLC) & Validation of DCS Delta V, various PLC, various SCADA, BMS (Honeywell EBI), Historian etc
  • Authoring change control activities, calibration updates, drawing updates, SOP updates, and related investigation.
  • Computer System Validation & all SLC System Life Cycle documentation for the various systems & process as per SOP and protocols of FDA, ICH etc

Validation Engineer

Catalent Pharma
10.2020 - 12.2021
  • Responsible for Installation, Qualification, Calibration and Maintenance of all Quality control laboratory equipment.
  • Performed Data Integrity Gap Assessment for simple systems and computerized lab instruments which are connected to network.
  • Involved in all Global DI meetings and report DI activities to Global CQV manager as a CQV specialist on behalf of Kansas Site.
  • Developed user access memo with users list and assigned roles to the users in the systems.
  • Developed local site Admin SOP which aligns with the corporate SOP.
  • Updated DI remediation Tracker every month and making sure all remediations are closed within the due date.
  • Reviewed and Updated Validation SOPs as needed in CDMS.
  • Drafted Audit Responses for all Observations regarding Data Integrity for Laboratory instruments.
  • Managed Deviations, Follow ups , and change control in Trackwise.
  • Performed Periodic User access reviews, Periodic Admin Audit trail reviews that are due every 12 months and managed Trackwise.
  • Reviewed System Impact Assessment which determines the overall system risk and system GAMP categorization.
  • Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR part 11.
  • Drafted summary report and Required traceability matrix for Dissolution systems.
  • Authored and Executed Equipment and Computerized Qualification protocol for Rudolph research Polarimeter which is connected to network.
  • Drafted DIA, VSR and RTM for polarimeter Created CSV IQ/OQ protocol for Mettler Toledo KF titrators, Potentiometric Titrators and Mettler Toledo pH meters.
  • Developed Master Computer Qualification protocol for all the XPR balances in QC and Micro labs.
  • Developed Application Patching Assessment when system is upgraded to higher firmware version.
  • Attended Change Control committee meetings every week to discuss new laboratory systems that are onboarded.
  • Raised three safety concerns in laboratory and one safety improvement and one positive safety behavior.
  • Performed the initial GxP assessment, Part 11 compliance assessment, authored protocols to test the interface and data workflow with multiple instruments for Lab X v8.
  • Validating Aseptic (fill and finish) process: Smoke studies, media fill simulations, worst case approach in APS, operating conditions, process interventions, Lyophilization, incubation and inspection, microbial growth medium, root cause determination and remediation in failures.

Validation Engineer – Hybrid (Contract)

Pfizer
07.2019 - 08.2020
  • Defined CQV strategies through the implementation of commissioning plans for process equipments.
  • Generate/Execute/Review Validation Protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facility (Production rooms, Warehouse, QA Sampling Rooms.) and utility qualification (Compressed Air system, HVAC system, Humidity control system, Dust collection system, Vacuum system, Purified (De-ionized) water system).
  • Experienced in developing/executing commissioning/qualification documents on the following types of equipment: HVAC Systems that serve classified clean rooms, supporting pharmaceutical utility systems, process equipment, automation systems, and associated instrumentation and controls.
  • Participated in validation execution on Water-for-Injection System, Pure-Steam System, and Cleanrooms.
  • Write, revise, and author SOP’s using document management software.
  • Executed Clean Room (supplied by HVAC Air Handler Unit) OQ Protocol using TAB (Testing, Adjusting and Balancing) Report.
  • Involved in authoring and executing SDLC deliverables such as URS, SRS, FRS, DDS, RTM, Unit, Integration, Commissioning Protocols, Manufacturing Equipment Qualification, UAT, Delta V, FAT, SAT, Validation Planning, IQ/OQ/PQ and (VSR).
  • Aiding validation teams with qualifications of utilities, autoclaves, Lyophilizer, vial washer and heat tunnel.


Validation Engineer -Hybrid (Contract)

Unither Pharma Manufacturing
09.2018 - 05.2019


  • Documentation included detailed project plans, system descriptions, testing plans, procedures, and forms, and incident reports.
  • Commissioning and Qualification of Clean Utility Systems such as: Water for Injection, Clean Steam, Purified Water, Compressed Air for Processes, and Clean Gases.
  • Development and execution of IQ/OQ/PQ documentation for temperature-controlled units such as freezers, refrigerators, and incubators.
  • Oversaw Equipment and Process Validation program to ensure all equipment went through a documented IQ/OQ/PQ & CQV process and all manufacturing processes were properly validated.
  • Reviewed and updated end to end validation documentation for Track Wise (CAPA, Complaints and CCM) to ensure compliance with company policies and procedures.
  • Knowledge of GLP, GMP, HPLC, UV/VIS, TLC, GC and other primary technology requirements and work methods.
  • Effective in the analysis of difficult issues, performing under the challenges of multiple tasks and closing due dates.
  • Ability to work as part of a team, handling details and preparing accurate and valuable documentation.
  • Involved in Operation Qualification using thermocouple calibration and Temperature Mapping of equipment like incubators, freezers, refrigerators, ovens.
  • Performed temperature mapping studies on various process equipment using Kaye Validator System (AVS) and Wireless Data Loggers.
  • Developed and Executed IQ and OQ protocols for Freezers, Refrigerators and CO2 Incubators.

Education

Master of Science - Biomedical Engineering

Wichita State University
Wichita, KS
2018

Bachelor of Science - Instrumentation

University of Mumbai
Mumbai, India
2015

Skills

Good listening skills
Multitasking abilities
Adaptability
Cultural awareness
Critical thinking
Leadership
Supervision
Planning and Coordination

Timeline

Cleaning Validation Engineer- Onsite (Freelancer.)

Hikma Pharmaceuticals (Boehringer Ingelheim Subsidiary)
09.2023 - Current

CSV/CQV Validation & Compliance Engineer- Onsite (Freelancer.)

Minaris Regenerative Medicine
01.2023 - 09.2023

Systems Validation Engineer- Onsite (Contract)

Boehringer Ingelheim Pharmaceuticals
01.2022 - 01.2023

Validation Engineer

Catalent Pharma
10.2020 - 12.2021

Validation Engineer – Hybrid (Contract)

Pfizer
07.2019 - 08.2020

Validation Engineer -Hybrid (Contract)

Unither Pharma Manufacturing
09.2018 - 05.2019

Master of Science - Biomedical Engineering

Wichita State University

Bachelor of Science - Instrumentation

University of Mumbai

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Rudra LLC - Candidate 01