United States
Proficient Validation Engineer with 5 years of experience in Equipment Validation, Packaging validation, Commissioning and Qualification Activities(CQV), Facilities and Utilities Validation, Computer system validation techniques in the medical device and pharmaceutical industry. Motivated to offer a quality-focused and systematic approach to solving issues and performing daily tasks alongside demonstrating the ability to complete tasks accurately despite interruptions and competing demands with good organizational, prioritization and communication skills.
· Develop and execute IOV (Installation and Operational Verification) protocols to meet regulatory requirements. · Develop and lead a high-performing technical team in Commissioning and Qualification validation engineering. Foster a collaborative environment that encourages innovation and professional growth. · Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for CTU's (cold storage units, freezers, blast freezers, refrigerators, incubators) and PSE units like autoclaves, washers etc · Provide guidance to sites with respect to CQV process deviations and change control as it pertains to systems and test equipment in production. · Support the validation program and procedural changes that enhance safety, compliance, and overall operational efficiency. · Continuously evaluate and identify opportunities for Improvement in existing CQV programs and procedures. · Develop and enhance professional communication skills within the team and across the organization. · Represent the CQV department in meetings, conferences, and industry events, effectively communicating technical concepts and project outcomes to diverse audiences. · Lead the planning, execution, and review of CQV projects, ensuring timely delivery and compliance with applicable regulations and standards. · Work closely with cross-functional teams, including engineering, quality assurance, and production, to ensure that validation processes align with broader organizational objectives.
· Develop and execute validation and equipment qualification protocols to meet regulatory requirements. · Assess and develop any amendments to the qualifications to deliver fully validated equipment into production within agreed timelines. · Qualified equipment's like Autoclaves, Bioreactors, Centrifuges, water bath etc. · Provide guidance to sites with respect to validation/process deviations and change control as it pertains to systems and test equipment in production. · Support the validation program and procedural changes that enhance safety, compliance and overall operational efficiency. · Support the site's adherence to the Validation Master Plan. · Continuously evaluate and identify opportunities for improvement in existing validation programs and procedures. · Participate in device risk management activities including FMEA and PFMEA · Provide direct technical support on production issues (eg. part & assembled product quality dispositions, interim containment actions, root cause analysis, resolution planning. validation, & implementation) under NCMR or CAPA. Use of Tools: DMS (Document Management System), SAP (Systems, Applications and Products in data processing), Track wise, PIMS, SharePoint
· Maintaining educational and professional knowledge by attending educational workshops and reviewing industry publications. · Drafted and executed qualifications on computerized systems like LIMS. · Drafted workflow SOP’s and other validation protocols. · Executed protocols, adhering to industry standards and regulatory requirements. · Collaboration with cross-functional teams facilitated smooth validation processes, maintaining complaint and efficient equipment systems. · Performed SIA (System Impact Assessment), CSA (Computer System Assessment), and NEC (New Equipment Completion) for various equipment. · Used CMMS SAP (Systems, Applications, and Products in Data Processing) for tracking and documenting compliance with GMP, GLP, and other regulatory standards. · Developing a gap analysis and conducting root cause analysis, deviation resolution. Use of Tools: Veeva Quality Doc, SharePoint, LIMS, SAP
· Performed validation activities for manufacturing Instruments such as Autoclaves, Washers, Isolators, Incubators, Refrigerators etc., · Executed IQ, OQ and PQ protocols through electronic execution (Using Kneat application). · Hands on experience on doing CCR’s (Construction Completion Record) in PIMS. · Extensive knowledge on using P&ID’s (Piping and Instrumentation Drawings) · Documented and reviewed FAT, SAT, cTOP (Construction Turn Over Package) and VDR (Vendor Documentation Record). · Provided support and guidance on equipment including HVAC system, Lyophilizers etc. · Prepared and reviewed Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report
· Generated IQ, OQ, PQ reports, drafted deviations report and Non-Conformance Reports (NCR). · Performed full process validations studies, beginning with process investigations and improvements up to final implementation of the validated process. · Performed Decommissioning for DI water system and Final assembled equipment’s. · Performed root cause analysis for product/process failures. · Write, review, and execute commissioning, qualification (IQ, OQ, PQ), and validation documents for equipment, facilities, and processes in compliance with cGMP rules and regulations. · Provided support and guidance on calibrating instruments like pH meter, balance, data loggers etc. · Assessed medical device DHF records (including design verification & validation documents, risk management files, process validation documentation, etc.) to determine completeness and compliance with FDA (21 CFR Part 820). · Developed a gap analysis and conducting root cause analysis, deviation resolution (CAPA). · Coordinated activities between on-site and offshore teams and ensured continued communication and accessibility between resources and business teams.