Process Validation Engineer

PRAVALIKA K

Mobile.no: +1-248-***-****

Email: ******************@*****.***

Linkedin Url: www.linkedin.com/in/pravalikak9

mailto:******************@*****.***

Summary: Results-oriented Validation Engineer with over 8+ years of experience. Well versed in effective communication and leadership while creating strong working relationships. Accountable, hard-working individual seeking a challenging work environment within the pharmaceutical manufacturing and FDA regulated industries.

Skills:

Process Validation

Test Method Validation

FMEA

Root Cause Analysis

Quality Audits

Traceability Matrix

FAT, SAT

Validation Master Plan

Validation Summary Reports

Temperature Mapping

Continuous Improvement

SPC

ISO 9001

cGMP

21 CFR Parts 210, 211, 820

ISO 13485

ISO 14971

Process validation including IQ/OQ/PQ

QSR

NCMR

NCR

PFMEA

DFMEA

Gage R&R

PFMECA

Documentation

Risk Management

Quality Records

Product Life Cycles

Professional Experience:

Senior Process Validation Engineer

Cosette Pharmaceuticals NJ March 2024 – Present

Led process validation activities for various pharmaceutical manufacturing processes, ensuring compliance with FDA regulations and cGMP standards.

Authored and executed validation protocols (IQ/OQ/PQ) for equipment and processes including tablet presses, coating pans, and packaging lines.

Conducted risk assessments and FMEA to identify critical process parameters and implemented control strategies to mitigate risks.

Successfully completed the full life cycle implementation of Manufacturing Execution Systems (MES) using Camstar (Siemens Opcenter) and GE Profic

Managed and executed temperature mapping studies for controlled environments and ensured that all equipment met validation requirements.

Collaborated with cross-functional teams to develop and maintain validation master plans, ensuring alignment with corporate quality standards and regulatory requirements.

Provided technical support and training to production and quality assurance teams, ensuring proper execution of validation protocols and adherence to SOPs.

Conducted a gap analysis of existing validation protocols, identifying critical areas for improvement and aligning them with current regulatory guidelines and best practices.

Proficient in Camstar (Siemens Opcenter) for MES, utilizing the platform to streamline manufacturing operations and enhance process control.

Implemented a risk-based approach to process validation, focusing on critical quality attributes (CQAs) and critical process parameters (CPPs) to optimize the validation effort.

Executed stress testing and stability studies for new formulations, contributing to the development of robust shelf-life projections.

Strong understanding of COA, CIO, and MIO interface connectivity, facilitating robust data exchange between MES and external systems.

Spearheaded the definition and implementation of the Factory Model within MES, aligning the system with the manufacturing workflow to enhance productivity and traceability.

Collaborated with the Quality Control department to develop and validate new analytical methods, ensuring reliable testing of in-process materials and final products.

Identified and mitigated project risks by implementing corrective measures during the testing phase.

Senior Process Validation Engineer

Merck NC Jan 2021 – Feb 2024

Author of Validation Lifecycle documents such as the Validation Master Plan, Computer System Validation Master Plan, User Requirement Specifications, Factory Acceptance Tests, Site Acceptance Tests, Installation Qualifications, Operational Qualifications, Performance Qualifications, and Process Validation protocols, as well as change controls, risk assessments, component criticality assessments and the traceability matrix.

Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks including PFMEA updates and escalation of Design Document changes as needed.

Extensive hands-on experience in Commissioning and Qualification (URS, FAT, IQ, OQ & PQ) of custom-built equipment such as Liquid Fillers, Tray Loaders, Filling Equipment, Vial Washers, Autoclave, Incubators, Temperature Controlled Units including Refrigerators, Cold Rooms and Freezers, Incubators and Validation of various other equipment including Process Vessels, Kill tanks, Blenders, Packaging, Bioreactors Coating Machines Packaging lines and other supporting systems.

Defined test plans and methodology to ensure all aspects of design verification and validation (V&V) were covered.

Provided Validation consulting servicesduring thegeneration and execution of qualification, validation and remediation protocols and reports. Reviewedand approved Commissioning, IQ, OQ and PQ protocols, reports, and related documentation .

Completed life cycle implementation of Manufacturing Execution Systems (MES) on COTS products like Camstar Enterprise Platform and GE Proficy, including system upgrades.

Collaborated with cross-functional teams, including Quality, Production, and IT, to ensure successful MES implementation and integration.

Computerized Systems (MES, SCADA, PLC), Equipment, Quality Control Laboratory, Utilities, proficiency in process plant automation, utilities, industrial networks, and gas systems, coupled with flexibility for travel.

Performing Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation tasks

Creating/releasing new test methods and revising/annotating existing test methods

Facilities and Process Validation.

Ensured strict adherence to ISO 13485 standards throughout product development, resulting in successful regulatory audits and zero non-compliance issues.

Perform validation activities for processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with 21 CFR Part 11.

Evaluated manufacturing and assembly processes to identify opportunities for improvement and provided actionable design feedback to enhance ease of manufacturing and assembly.

Functioned as a Solution Architect, responsible for upgrade planning, design, coding, and development of CIO/MIO maps and workflows.

Defined test plans and methodology to ensure all aspects of design verification and validation (V&V) were covered.

Authored, executed, and summarized a lyophilizer Authored test methods for some existing work instructions and developed strategies to validate them.

Programmed and calibrated Keyence measurement systems to precisely monitor critical dimensions and tolerances, ensuring accurate and reliable process measurements.

Conducted troubleshooting and maintenance of Rockwell control systems to ensure continuous and reliable operation.

Conducted site acceptance testing (SAT) for the final handover/approval from clients.

Extensive experience in equipment calibration, performance evaluation, and quality assurance, demonstrating the capability to uphold the reliability and regulatory compliance of laboratory systems and procedures.

Collaborated with cross-functional departments to identify process improvements and drive continuous improvement initiatives partnered with the R&D and Tech Transfer departments during development.

Prior employment history as a validation engineer or in a comparable role, indicating hands-on experience and expertise in executing validation activities, ensuring compliance with industry standards and regulatory requirements.

Ensured compliance with regulatory standards and quality management systems throughout the V&V process.

Extensive hands-on experience with Rockwell Automation systems, including programming and configuring Allen Bradley PLCs (Programmable Logic Controllers).

Applied Siemens CAMSTAR knowledge to streamline workflows and enhance MES capabilities in the medical device manufacturing sector.

Collaborated with tooling engineers to design and refine injection molds, enhancing product quality and reducing manufacturing defects

Spearheaded the development and optimization of injection molding processes to improve product quality, reduce cycle times, and increase overall production efficiency.

Successfully integrated Keyence systems into manufacturing processes, improving efficiency, and reducing manual labor costs.

In-depth understanding of manufacturing procedures and a steadfast commitment to upholding safety protocols, underscoring a dedication to maintaining a secure and compliant working environment.

Leveraged Keyence machine vision technology to automate inspection processes, reducing manual labor and ensuring consistent product quality.

Led the successful implementation of ISO 13485 quality management systems, ensuring alignment with regulatory requirements and industry best practices.

Lead the qualification of the depyrogenation tunnel and aseptic vial filling line speed integration.

Provided training to production personnel on best practices for injection molding operation, maintenance, and troubleshooting, resulting in a skilled and efficient workforce.

Responsible for creating and executing validation documents on equipment and facilities under GMP Documentation practices including change management system.

Performed FAT of an isolator-enclosed Shibuya aseptic vial and ampoule filler, suggesting modifications to minimize glassbreakage, and to better adjust for the height discrepancies at the seal placement station.

Performed equipment installation, manufacturing process characterization, capability studies, OperationalQualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as process/test method validation for manufacturing equipment.

Maintenance of GC/GC Headspace Sampler, Microbalances/Analytical balances, and Centrifuges in a laboratory setting.

Conducted detailed process analysis and implemented continuous improvement initiatives to enhance line performance and productivity.

Applied lean manufacturing principles to streamline injection molding operations, reduce waste, and improve overall efficiency.

Provided technical support and training on Siemens automation systems to maintenance and operations personnel.

Experienced in upgrading laboratory equipment to Windows 10 operating system, ensuring seamless integration and functionality.

Designed wireframes and dashboards to visualize MES data, facilitating informed decision-making and process improvement.

Knowledgeable in integrating MES applications with external systems such as ERP, LIMS, and Equipment/HMI, ensuring seamless data flow and process automation.

Strong expertise in CSV (Computer System Validation) as per 21 CFR Part 11 regulations, ensuring compliance with industry standards and regulatory requirements.

Skilled in implementing GAMP5 (Good Automated Manufacturing Practice) guidelines for the upgrade and integration of laboratory systems generating electronic data.

Proven track record in executing successful upgrades while adhering to strict regulatory standards, enhancing efficiency and reliability of laboratory operations.

Created a plan of experiments document (DOE) to evaluate protein formulations, glass vial compositions, lyophilization cycle development, and vial handlingSupported equipment troubleshooting and close out of discrepancies and deviations.

Designed and executed process validation studies, including equipment qualification, process capability studies, and statistical analyses, to ensure robust and reliable manufacturing processes for medical devices.

Responsible for the preparation of site validation documentation such as qualification protocols, validationmaster plans, risk assessments and periodic reviews.

Collaborated with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to coordinate validation efforts and address validation findings for AgileMap, Windchill, and SAP PLM deployments

Applies or swiftly acquires proficiency in cGXPs, relevant SOP curriculum, and standard project procedures to ensure adherence to regulatory standards and efficient task execution.

Performed facility qualification, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification) along with utility qualification for the following systems: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), Chilled Glycol.

Previous engagement in Quality Control (QC) Lab operations, particularly focusing on analytical instrument validation and seamless system integration, accompanied by exceptional communication skills tailored to effectively engage with both technical specialists and business stakeholders, facilitating smooth collaboration and cohesive project execution

Outstanding proficiency in both written and verbal communication, crucial for effectively engaging with technical and business stakeholders, delivering executive reports, and facilitating meetings with various parties. Additionally, previous experience in multinational environments highlights adaptability and cross-cultural communication abilities.

Authored test protocols and designed experiments (DOE) to validate system and component performance.

Seagen WA Nov 2019 – Dec 2020

Process Validation Engineer

Responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment: review and approve executed qualification /validation documents, for facilities, processes, and equipment.

Performed IQ, OQ, PQ and TMV for processes in manufacturing.

Prepare the Operational Qualification for Camstar MESSystem, and execute the OQ as part of Validation of the Camstar MES System.

Wrote and executed requalification of VHP Sterilization processes in aseptic manufacturing of CTMs to ensure.

compliance with ISO and Sanofi Corporate requirements for validation.

Authored process validations for two fill lines involving the aseptic processes of Gruenberg ovens and Cozzoli vial fillers,all with Allen-Bradley PLCs.

Assisted in the execution of OQ protocols for VHP-decontamination of, and environmental monitoring (viable and non-viable) of class 100 barrier isolators.

Performed VHP (Vaporized Hydrogen Peroxide) Cycle Development runs to identify critical Cycle Parameters and to make sure Acceptance Criteria was met prior to performing actual VHP Performance Verification runs.

Participated in deviation investigations to identify root causes and define corrective/ preventative actions (CAPAs).

Supported process and product improvement initiatives and analyzed product performance to identify trends as necessary.

Supported the evaluation of existing system modifications to evaluate risk, establish and implement a qualification strategy, as applicable to the specific change

Investigated instances of nonconformance and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions.

Supported validations to assure all processes comply with company specifications to include internal quality systems and ISO requirements as well as applicable regulations.

Reviewed and approved all associated documentation including risk management files and quality records.

Ensured documentation is aligned with corporate standards which includes FMEA, DFMEA, Manufacturing Process Characterization / PFMEA, product life cycles, Gage R&Rs.

Maintenance of CAPA and NCR files. Tracked and reported CAPA and NCR trends.

Developed Site Selection documents and applicable Work Instructions based on the risk assessments and drafted room layouts using AutoCAD to validate cleanrooms through VHP.

Worked on CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconformingmaterial, training effectiveness, and root causes analysis.

Prepared and executed Validation and Installation Qualification (IQ), Operational Qualification (OQ),

Performance Qualification (PQ) for process equipment such as autoclaves, mixers, cold-rooms, storage, facilities,lab equipment (FTIR, HPLC, UV VIS), autoclaves, incubators, cabinets, flow hoods, mixers, aseptic filling machines, bioreactors, and process control systems.

Vertex Pharmaceutical Boston, MA June 2016 - Aug 2019

Validation Associate

Ensured protocols, verifications, validation plans, and summary reports generated during validation/qualification activities are stored according to procedure.

Drafted SOPs, batch records, and line templates.

Worked with cross functional teams (Facilities, Manufacturing, Quality Control etc.) to perform multiple VHP Performance Verification runs till the optimal surface sanitization was achieved.

Participated in developing and updating Equipment and Software validation protocols and change controls.

Identified Equipment and Equipment validation quality critical parameters and updated the specifications.

Wrote, updated, and revised the production batch and Equipment validation reports.

Coordinated and supported the execution of Equipment validation activities.

Reviewed and approved the test methods and sampling plans for Equipment validation.

Participated in technology transfer activities.

Supported in writing master validation plan for Equipment validation activities.

Involved in writing deviations and performing Effectiveness checks.

Education

Bachelors of pharmacy -Vignan’s Institute

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