Production System Engineer at Sanofi (2026-01 – Present)
As an independent thinker and keen problem solver, diagnosed technical issues and provided technical solutions/recommendations for Operations manufacturing systems.
- Diagnosed automation and process related issues in the production area (Upstream, Downstream, Adsorption and Media/Buffer Systems) and perform/support root cause analysis and implement corrective actions to maintain schedule adherence and minimize downtime.
- Provide engineering support for production and maintenance activities to ensure maximum production and minimum downtime.
- Collaborate with multi-functional teams (Automation, Maintenance, Operations, Manufacturing Technology, Quality and HSE) to resolve technical issues and provide resolutions.
CQV Consultant at Hyde Engineering (2020-04 – 2025-12)
Responsibilities as a Sr. Validation Consultant involved in driving CQV and process validation by consulting with clients in an engineering role. Provided support to MSAT and CQV teams in generating technical documents, supporting MES design and automation changes for B100 processes, and execution of validation activities.
MSAT Process Validation Support (B100 Diphtheria and Tetanus Manufacturing) at Sanofi (2023-02 – Present)
- Led root cause analysis and gap analysis on the production floor using methodologies such as FMEA, 5 WHYs and Fishbone diagrams.
- Investigated non-conformances and deviations; supported development and implementation of CAPAs to address root causes and ensure sustained GMP compliance.
- Assisted in KPI creation and provided coaching for continuous improvement; familiar with QDCI, Obeya, Gemba Walks, and OEE tools for M&R value monitoring.
- Participated in stakeholder meetings to ensure change controls, non-conformances, and applicable documentation followed per timelines — supporting audit readiness and technical governance.
- Assisted in Functional Specification, MES mapping and modelling master batch records to MES for Diphtheria and Tetanus processes in B100.
- Supported process improvement/continuous improvement in efforts to make manufacturing process efficient.
- Supported CQ execution phase and process validation B100 project (Engineering and PPQ) in coordination with Operations, Automation and Quality.
- Drafted & reviewed cleaning validation, pre-engineering and engineering protocols & reports and drove review and approval process.
Validation Consultant at Integra Life Sciences (2022-05 – 2022-11)
Ensured the project documents and executions are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO and other applicable requirements.
- Led thermal validation drafting and execution of protocols.
- Drafted NCs, conducted investigations and wrote reports for the executed protocols.
Commissioning & Qualification Consultant (B100 Project) at Sanofi Pasteur (2020-04 – 2022-04)
Drove and delivered the executions of field-based CTP executions – Installation Verifications, Start-up/Shakedown (commissioning) and Operation Verifications of systems found within the CQV Workstream (such as CIP systems, temperature control units, mobile tanks, chromatography, UF skids etc. using Delta V and PLC system automation systems.)
- Performed troubleshooting for manufacturing systems such as Delta V, Allen Bradley PLC, HMI and PI Historian and collaborated with automation team to implement code changes.
- Safe execution of field-based commissioning testing including but not limited to; P&ID walkdown, internals inspection, slope & deadleg verification, agitator commissioning, temperature & flow control tuning, CIP Commissioning, SIP commissioning and various dynamic testing as identified per URS.
- Reviewed C&Q test plans, FCCA documents, FAT and SAT documents for technical content.
- Participated in and led CQ execution/critical test plan execution for timely completion of all assigned execution deliverables and meet project schedule.
- Ensured test scripts fulfilled URS's requirements and test scripts executed followed good documentation practices and compliance requirements were met as planned.
- Provided support to CQV team in generation of technical documents such as Commissioning test plan, Validation protocols and final summary reports for client in regulated industry.
CQV Consultant at AtkinsRealis (2018-07 – 2020-03)
As an Intermediate CQV specialist, provided support to CQV team in generation of technical documents including Qualification and Validation protocols, reports and performed IQ/OQ/PQ testing for clients in Biopharmaceutical and Cannabis Industry.
- Wrote technical documents including SOP, Commissioning test plan, Validation protocols and final summary reports for client in regulated industry.
- Developed and executed IQ/OQ/PQ protocols for various GMP manufacturing equipment such as particle counter, flow cytometer, biological fume hood, semi-automated liquid filler, CO2 extractors, Vacuum oven, Rotary Evaporators, floor scales, peristaltic pumps, THC and CBD oil Distillation unit and various other lab equipment (such as CO2 incubators, freezers and fridges, biosafety cabinets, particle counters, microplate reader).
- Conducted data analysis of executed protocols, drafted summary reports and recommended changes based on data collected.
- Liaised with client, sought feedback and input during the development of SOPs as well as drafting of validation protocols.
- Performed Thermal Validation via Kaye Validator using thermocouples and/or data loggers for temperature mapping studies.
Project Lead Supervisor - Downstream Production at Resilience Biotechnology Inc. (2015-01 – 2017-04)
- Communicated project status report to key stakeholders, analyzed and provided them with timelines, solutions to foreseen problem/risks and implemented decisions to execution.
- Conducted root cause analysis to determine deficiencies and solve process/equipment related problems, and worked closely with QA to close deviations, create CAPAs and review batch documentation to ensure efficient production.
- Designed, wrote and reviewed protocols, Standard Operating Procedures (SOP), batch records, Validation reports and created Bill of Materials (BOMs) and URS related to GMP processes.
- Acted as the lead project authority to coordinate between essential internal and external resources to ensure project deliverables and key performance indicators (KPIs) are met and communicated to stakeholders.
- Designed reports to capture GMP batch incident information and used data to track equipment use, KPIs, equipment cleaning cycles, manufacturing batch duration etc.
- Managed multiple priorities, detail oriented and met deadlines under pressure.
- Facilitated daily, weekly and monthly project team meetings to troubleshoot issues, and to ensure deliverables are kept on track.
- Collaborated with vendors and finance team to obtain P.O.s and invoices for ordered materials.
- Monitored and documented daily operational performance, and provided insightful feedback and mentorship based upon individual strengths and opportunity for improvement.
Production Lead - Downstream Processing at Resilience Biotechnology Inc. (2014-03 – 2015-03)
Provided training to operators on processes.
Manufacturing/Operations (General Role) at Resilience Biotechnology Inc. (2013-02 – 2017-04)
Established cross-functional relationships with facilities, QA, QC raw materials, QC chemistry, QC microbiology, technical services, and project managers to ensure accurate origination and timely completion of processes. Developed and monitored operations schedule for as many as 20 manufacturing professionals overseeing compliant GMP batch completion. Structured and analyzed KPIs used to measure accurate process times, yields, operator and process variations, and machine and equipment performance.
