Thanks to my various experiences, I have a versatile profile in the pharmaceutical sector. I am looking for a position as CQV expert or process engineer.
Overview
8
8
years of professional experience
Work History
Project Coordinator - Automation / Process Control
RealDev
11.2023 - Current
Projects management in industrial automation and digitalization, from study to production implementation, including the implementation of technical modifications and user training, with the aim of managing obsolescence, ensuring regulatory compliance, and optimizing production equipment for the pharmaceutical industry (Autoclaves, centrifuges, chromatography, Dry-Fog)
Management of subcontractors for installation or modification activities on GMP equipment (Work permits, operating procedures, LOTO, legal inspection, technical testing, investigation, calibration, maintenance)
Management of the CQV/CSV activities (Writing of protocols, execution of testing, updating of design documents with Kneat, Veeva and SAP)
Project management and tracking documentation update (Reporting, Tracking, KPIs, Planning, Risks & Issues), management of project meetings at different levels (from daily team meetings to sponsor meetings)
Project Leader / Process Engineer
UCB
07.2021 - 06.2023
Writing and reviewing the documentation for the implementation of new equipment and processes for the aseptic filling of biological molecules (change control, URS, specifications, risk and impact analysis, FAT/development/validation protocols, reports, SOPs, deviations)
Developement of action plan to increase production capacity and process optimization linked to FDA audit
Task monitoring with different project SMEs and reporting of KPIs (Budget, planning, resource, deliverable, quality)
CQV Engineer - Process Equipment & CSV
Takeda
05.2018 - 06.2021
Participation in the commissioning and validation of a new purification/formulation line for biopharmaceutical products (Skid UF/Vessels), and associated cleaning systems (CIP) and automated systems (PCS, SCADA, HMI, EBR)
Validation of cleanrooms and associated HVAC systems, storage areas and industrial freezers
Writing all V cycle documentation: Validation plan, URS, FDS, Design Review, risk analysis, IQ/OQ/PQ protocols, reports, deviations
Product & Process Engineer
GSK
02.2017 - 03.2018
Development of a new agitation technology for mobile tank formulation of vaccines (FAT, commissioning, test result analysis)
Writing the documentation associated (URS, test protocols, reports, SOP for user/maintenance)
Management of technical testing and coordination of the project with internal and external stakeholders
Education
Certificate -
PRINCE2 Foundation
01-2021
Ecole De Biologie Industrielle
01-2017
Driver License
B
Languages
French
Bilingual or Proficient (C2)
English
Advanced (C1)
Espagnol
Intermediate (B1)
Timeline
Project Coordinator - Automation / Process Control
<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.