Nilesh Damale

Currently serving as a CSV and CQV Lead for a European pharmaceutical client with facilities across Europe, the US, and Asia. Responsibilities include:

• Supporting the validation of Business Analytics/Business Intelligence applications such as Qlik Sense, Power BI, Snowflake, and AI/ML-based platforms.
• Leading global SAP S/4 HANA implementation and enhancement projects.
• Acting as a CQV Specialist from QA, defining strategies and providing guidance for the qualification of QC instruments and applications, including ELLA Platforms, Bact T Alert System, LIMS, LabX, Flow Cytometers, and Nucleocounters.
• Managing changes and deviations for computerized systems using tools like TrackWise, Veeva Vault, and ServiceNow.
• Authoring, reviewing, and approving end-to-end validation deliverables in both project and operational phases.
• Conducting CSIA reassessments for over 140 systems as part of a gap assessment and remediation effort to classify systems based on business criticality, GDPR, SOX, and GxP relevance.
• Supporting CMA implementation by identifying and ensuring the effectiveness of controls throughout the system lifecycle.
• Contributing to various initiatives within Infosys, including CMA Offering, CSA Offering, Future of Compliance, AI-Assisted Audits, and the role of Gen AI in compliance.
• Engaging in client proposals to understand requirements and deliver tailored solutions.
• Authoring a white paper on an integrated approach to commissioning, qualification, and validation.

Reporting to the client’s IT CSV Director, serving as a CSV Lead in the Life Sciences domain. Key responsibilities include:

• Leading Oracle JDE 9.1 global and site roll-out implementation project
• Supported continuous improvement project for Oracle JDE 9.1
• Leading the Global SupplyFlex project, involving a cloud-hosted Salesforce deployment interfaced with multiple client systems.
• Reviewing and approving validation deliverables such as HLRA, HLBRA, SRS, FRA, CS, DS, IQ, OQ, PQ, RTM, VSR, and validation deviations using automated validation tools like ValGenesis.
• Participating in global client meetings and providing updates on Go/No-Go activities as required.
• Identifying gaps between client expectations and project delivery, implementing continuous improvement measures as per the regulatory requirements and industry best practices.
• Collaborating with internal and client cross-functional teams to ensure timely delivery, escalation handling, and issue resolution.
• Preparing Requests for Proposal (RFPs) with a focus on validation aspects.
• Defining validation strategies for ERP system core functionalities and site-specific enhancements for modules such as Warehousing, MEP, Capacity Planning, Engineering to Order, Inventory Management, Manufacturing Planning, Mobility, Purchasing, Sales Order Management, and Shop Floor Control.
• Establishing test strategies for JDE Menus, MEP Menus, UDC translation, configuration, and verification across lower (DY/PV), Quality, and Production environments.
• Planning, reviewing, and approving IST system testing, integration testing, unit testing, functional testing, deployment IQ, enhancement qualifications, and production deployments.
• Raising change controls in TrackWise for JDE changes, including IST, QA configuration, QA data migration, qualification, production deployment, and release activities.
• Utilizing an Agile lifecycle approach to ensure product delivery within defined timelines.
• Estimating CSV man-hour efforts based on project length, criticality, and client requirements.
• Preparing and reviewing SOPs and training materials, conducting associate training, and performing project audits.
• Conducting gap analyses through audits and implementing remediation plans.
• Ensuring adherence to client procedures and regulations, guiding the team to achieve compliance.

• Worked in Life Science Domain for Well Reputed MNC Pharmaceutical Company as a Validation Consultant
• Review of CSV deliverables like Validation Project Plan, URS, VP, DS, FS, TM, IQ, OQ, PQ, UAT, Computer System Risk Assessment, Periodic Review Report, SOP etc
• For global and site level software like QAMS, LIMS, Chromeleon and other standalone systems to ensure they meet GxP and FDA regulations
• Define qualification strategy and roadmap for PLC/ DCS based systems, BMS, EMS systems
• Perform gap analysis, root cause analysis, investigation of deviations, risk assessment etc
• Ensure adherence to client procedures and regulations and guide team to achieve the compliance

• Authored, reviewed and approved CSV deliverables like Validation Project Plan, URS, VP, DS, FS, TM, IQ, OQ, PQ, UAT, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOP etc
• To ensure they meet GxP and FDA regulations
• Participation in all FAT and SAT activities to guide team for execution of test cases, handling deviations/ defects occurred during testing
• Abundant experience in generating and reviewing Computer Systems Validations CSV deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries
• Worked as Engineering QA to ensure compliance of Engineering documents Validation and qualification deliverables, calibration certificates, maintenance reports, change control and deviation investigation reports are complied with applicable regulations and organizations policies and procedures
• Working closely with cross-functional project team for execution of qualification/ validation of equipment like compression machine, coater, autoclave, and utilities like HVAC, BMS, RMS, EMS, UMS, PLC, DCS, SCADA, HMI, purified water system and associated PCS
• Co-ordinated with the vendors in commissioning of the instruments upgrade software, implement new system or maintenance of systems, system suitability tests, and resolving technical issues
• Good experience in Gap Analysis and documenting Remediation Plan
• Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems
• Participated in design reviews finalizing designs which clarified and defined software requirements of Manufacturing, QC, Utility equipment/ instruments and supporting computerized systems
• Supported to create, revise, and update control system SOPs in support of protocols, computer system changes
• Performed routine system administration tasks on all process equipment systems, QC systems/ instruments and networks
• QA lead for all new in-house projects to ensure quality is maintained and specifications are appropriate and attainable
• Review of drawing like P & ID, GA, Electric Wiring Diagram, Block Logic Diagram, Isometric Drawings etc
• Internal auditing for Engineering Compliance
• Ensured all planned and unplanned maintenance activity and its impact on Equipment/ System/ Area
• Ensured GEP and GMP in all new incoming projects and modifications of existing equipment, areas, facilities
• Participate in project meetings to ensure timely completion of ongoing projects
• Perform GAP analysis, Risk Assessment using FMEA model, implement Quality Risk Management Systems to define validation strategy, prepare risk scenario and RPN evaluation, identifies critical control points, determine degree of testing required, define test procedure and acceptance criteria on the basis of current controls verified from functional and design specification submitted by manufacturer
• Periodic review of software systems by challenging the system and verifying its performance during abnormal conditions and beyond operational limits
• Verification of existing application software for 21 CFR part 11 compliance, determination of possible quality risks
• Support the internal/external audits and regulatory inspections form validation perspective, perform FAT/SAT for PCS and equipment and approve procedures and deliverables
• Provide training to Qualification team, end user department with respect to qualification, computer system validation, GDP, GMP etc
• QA oversight to Engineering Department to ensure that proper procedure has been followed while performing planned, unplanned maintenance, calibration etc
• Actively participated in technical change control, deviation, and investigation management

• Responsible for set up of sterile facility, managed all activities for new setup as a QA Engineering (Pharma Engineering) representative to ensure that all the new utilities, equipment’s, instruments, facility are installed as per the regulatory requirement
• Carried out mapping activities to ensure that room viable, non-viable particle requirements are in line with ISO requirements
• Equipment qualification and computer system validation using ‘V’ model- starting from URS review, perform Installation Qualification, Operational Qualification for equipment hardware and software like DAS, PLC, HMI, SCADA, Autoclave, Fermenter, Particle Monitoring System, Tunnel, Washer, TFF, BMS, MCDP, PW S & D, CIP, SIP, BMS, EMS, HVAC, RMS, EMS, packing machines, externally developed process control applications etc
• Review of equipment/ system qualification documents like URS, FDS, SDS, HDS, IQ and OQ for equipment like Autoclave, TFF, Particle monitoring system, Data acquisition system, freezers, cold room, extraction systems, MCDP, WFI S & D and other portable and customized equipment
• Preparation of Project Plan, performing FAT at supplier site, Preparation of TM
• Exhibits excellence in reviewing various engineering drawings & documents like control philosophy, instruments list, P & ID, Logic Diagrams and instrument loop drawings, Hook-up drawings, valve matrix, schematic drawings, alarm occurrence reports, service reports
• Attended FAT along with all stages of equipment qualification for Continuous Extraction System (PALL), Autoclave (Sterdil), Vessels (Biozeen), TFF System (Sartorius) etc

• Responsible for Erection, commissioning and testing activities for new Oncology facility
• Managing all in-house project related activities, installation and commissioning of PLC and PC aided systems linked with CIP, SIP, Autoclave, BMS, HVAC, RMS, EMS, DAS and PWS & D systems, Washers, Tunnels etc
• Qualification of Particle monitoring system, PLC and PC based system validation including verification of audit trails, database integrity, access levels, security levels, data archival and backup verification, I/O verification, set parameters verification etc
• Periodic revalidation of PLC systems, Data Acquisition systems for verification of system integrity by challenging the system to verify its performance in abnormal conditions
• Understanding various instrumentation deliverables like P & I Diagram, Hook-ups, and Logic Diagrams, Wiring Diagrams, and Control schematics

• PLC and PC based systems installation, commissioning, and validation
• Periodic verification of SCADA and automated systems to verify system performance
• High Pressure Boiler Automation-Erection, commissioning High pressure boiler instrumentation having capacity of 55TPH and pressure of 65 kg/cm2