Rahul Waghmare
Pune
Summary
Dynamic Automation Engineer with extensive experience at Moderna, excelling in Delta V configuration and PLC integration. Proven track record in enhancing operational performance and ensuring compliance with regulatory standards. Adept at technical troubleshooting and project collaboration, leveraging Six Sigma expertise to drive continuous improvement in automation systems.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Automation Engineer and Delta V Consultant
Moderna
Norwood
06.2024 - Current
- Configure Delta V systems like TMix, SUPR+, SoloVPE to align with project specifications, enhancing operational performance and reliability.
- Integrate PLCs with Delta V systems to facilitate efficient communication and data exchange, resulting in improved system responsiveness.
- Develop and implement intuitive HMI configurations for PLCs, ensuring ease of use for operators and technicians.
- Draft IQ for different manufacturing systems, detailed Control System (CS) and Control Design Specification (CDS) documents, outlining system requirements and design specifications for team reference using tools like SharePoint, Kneat, Veeva Quality compliance standards.
- Collaborate effectively with engineers, technicians, and project managers to ensure successful project delivery and adherence to timelines.
- Troubleshoot and resolve technical issues related to Delta V systems, PLCs, and HMIs, providing support both independently and as part of a team.
CSV and Data Integrity Engineer
ThermoFisher Scientific
Greenville
09.2022 - 05.2024
- Executing/ conducting Data Integrity Assessment for all the manufacturing and Lab Equipment (SkanIt software) in Animal health and OSD facility, using cGMP, 21 CFR Part 11, GDP, GAMP, S88 standards.
- Working with tools like eDMS, Trackwise, SharePoint as an author for creating, Administering, approving, and routing for final approval to Quality and Technical SMEs.
- Drafting, Reviewing, Approving the Data Process Map for manufacturing equipment.
- Managing all the DI assessment documents for equipment use and making sure they compliance with GxP.
- Working with cross functional teams like Automation, IT etc. during execution of DI assessment.
- DI Assessments of Operation system, DeltaV, HMI, Computer systems, Lap Equipment and supporting software.
Automation Engineer
Pfizer-Global Supply
Kalamazoo
01.2022 - 08.2022
- Providing engineering and automation support related to the installation, commissioning, testing and qualification, operation and maintenance of process and automated equipment and systems within a Vaccine formulation facility, this includes production equipment such as bioreactors, ultrafiltration skids, Clean-In-Place (CIP) skids, other support equipment and DeltaV automation systems.
- Provide on the floor operational support as needed. Support the team in equipment troubleshooting and program changes.
- Support equipment Start, Run, Stop, Aborting and its functional verification. Ability to read 2D drawings and P&ID.
- Support team in production and collaborate with process engineers in testing Equipment modules and phases, Continuous Controls, Critical and non- critical Alarms, Digital Inputs, and Interlocks.
- Following Current Good Manufacturing practices (cGMP) and Good Document practices (GDP).
- Collaborating with Verification Engineering in executing the equipment test followed by generating reports for Non conformances, implementing code changes and Re-testing the equipment.
- Validating control and automation systems such as Allen Bradley PLC’s, SCADA, HMI, Building Automation Systems (BAS), FTBATCH, FT Recipe Editor, Smartsheet, Wonderware system, PlantPAX (Allen Bradley), FT VIEW ME & FT VIEW SE systems.
- Supporting team in configuration and functional test followed by creating a batch in HMI and Executing PLC’s.
Computer System Validation Engineer
SITES Medical
Colombia City
05.2021 - 01.2022
- Assisted in planning and documenting validation project plan, reviewing engineering reports and risk assessment to identify gaps and recommending necessary development.
- Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance.
- Documented Validation Plan, Validation Summary Report for SAP roll outs and implementing interfaces between SAP and other manufacturing systems.
- Approve SDLC defects closure with relevant root causes and suitable CAPA in JIRA & HP ALM.
- Involved in writing and executing test cases and test scripts to validate certain functionalities of LIMS.
- Providing training (e.g. SOPs) on an annual basis and maintaining training records as new procedures become effective. Carrying out duties in compliance with all SOPs, Pharmaceutical regulations such as 21 CFR Part 11, 210, 211, and FDA regulations, cGMP, GLP, GCP, ICH, USP and European regulations guidelines.
- Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations.
- Workflows implemented included complaints, CAPA and Change Control.
- Wrote SDLC deliverables including change requests, validation master plans, test plans, implementation plans, data migration plans, user/system requirements, design, test documents, and traceability matrices for multiple GxP systems.
- Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts using HP ALM and executed them.
- Executed validation test cases based upon system requirement and FDA standards. Tracked and closed the defects using HP ALM.
- Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP and GMP) FDA Assessment.
- Provided leadership in the efficient application of the Quality System Regulation, (QSR) as it applies to the R&D efforts at a facility dedicated to the R&D function up through and inclusive of Design Transfer.
- Validated computerized laboratory equipment based on GAMP 4 & 5.
- Provided FDA 21CFR Part 11 Documentation Remediation for corporate-wide Clinical Trial System.
- Involved in all phases of SDLC according to Company procedures, FDA Guidelines, GMP and (21CFR Part 11).
System Validation Engineer
UPS Supply Chain Solutions
Harrisburg
01.2021 - 03.2021
- Leading clients in documentation of user requirements.
- Authoring user and functional requirements specifications that are complete, accurate, and testable.
- Authoring Functional Traceability Maps (business process workflows).
- Creating Architecture Diagrams, Design, and Configuration Specifications.
- Updating Validation Master Plans.
- Authoring validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices.
- Executing validation and verification testing protocols and documenting results.
- Authoring OQ and PQ Summary Reports and Validation Summary Reports.
- Authoring SOPs for System Administration, Change Control, Configuration Management, Back-up/Recovery, Security Management, Troubleshooting and Repair, Performance Monitoring, and Archival/Retrieval.
- Preparing status reports for client.
Safety Intern
Garabedian Associate (USAA)
San Antonio
01.2020 - 12.2020
- Data analysis was gathered during the actual drill (at USAA, SA) to find the physiological effect on individuals during emergencies.
- Study NFPA/ IBC/ IFC/ FEMA documents for suggesting stair tower capacity during emrgencies.
- Experience with research, design, and developed methods /plan of action d=for emergency.
Business Development Executive
Source Code technology
Pune
01.2017 - 12.2019
- Organized schedules, workflows, and shift coverage to meet expected business.
- Supported sales management to optimize business development.
- Vendor sourcing.
- Recruitment and training of new staff.
Quality Auditor
Redi India (TATA Motors Warehouse, Chakan)
Pune
03.2016 - 12.2016
- Process audit Auditor for seamless and faster product movement of parts in the warehouse.
- Managing/ maintaining 5s and ISO audits to ensure efficiency, safety, and standardization in the workplace.
- Resolve inefficiencies using Quality improving techniques like 8D problem-solving technique,five whys, Design experiments, check sheets, process maps, and
continue the improvement of the infrastructure of the warehouse. - Training and mentoring new hires.
Education
Master of Science - Project Management
University of Cumberland's
Kentucky01-2023
Master’s - industrial engineering
St. Mary’s university
San Antonio01.2019
Bachelor of Engineering - Mechanical Engineering
Pune University
Pune01.2015
Skills
- PLC Allen Bradley Studio 5000
- Delta V configuration
- PLC integration
- Data integrity assessment
- HMI development
- Control system documentation
- Process automation
- Compliance management
- Project collaboration
- Technical troubleshooting
- System validation
- Quality assurance
- Regulatory compliance
- Risk assessment
- Six sigma expertise
- Documentation management
- RsLogix 5000
- Six Sigma Green Belt
- HTML
- Python coding language
- AutoCAD
- PTC Creo
- Delta V Systems
- PLC Programming and Integration
- HMI Design Tools
- Microsoft office
Certification
- Project Management Certification
- Six Sigma Green Belt
- Prince2 Agile
Languages
Marathi
First Language
Hindi
Proficient (C2)
C2
English
Proficient (C2)
C2
Timeline
Automation Engineer and Delta V Consultant
Moderna
06.2024 - Current
CSV and Data Integrity Engineer
ThermoFisher Scientific
09.2022 - 05.2024
Automation Engineer
Pfizer-Global Supply
01.2022 - 08.2022
Computer System Validation Engineer
SITES Medical
05.2021 - 01.2022
System Validation Engineer
UPS Supply Chain Solutions
01.2021 - 03.2021
Safety Intern
Garabedian Associate (USAA)
01.2020 - 12.2020
Business Development Executive
Source Code technology
01.2017 - 12.2019
Quality Auditor
Redi India (TATA Motors Warehouse, Chakan)
03.2016 - 12.2016
Master of Science - Project Management
University of Cumberland's
Master’s - industrial engineering
St. Mary’s university
Bachelor of Engineering - Mechanical Engineering
Pune University
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