Switzerland
A constant thread throughout in my career is my dedication in Engineering & Manufacturing, ensuring that pharmaceuticals products are delivered within the highest quality and efficient process. This means a deep commitment to delivering and driving efficiency through streamlining processes, sharing best practices and supporting people growth. I am particularly passionate about working in a matrix organization in order to ensure that the best results within the company are achieved. I am always advocate for working in partnership to make sure quality of produced drugs is delivered according to company timelines, in order to guarantee customer and patient satisfaction. 10+ years in the pharmaceutical industry holding various responsibilities across the value chain including Commissioning & Qualification & Validation, Head of Engineering (Maintenance, Calibration, Process), Project Management and New Product Introduction Design.
Pharmaceutical and Biotech industry (Life Science) - Biologics - Drug Product Services (DPS) - Fill & Finish / DP CQV Lead of a team of 3-8 CQV Engineers Matrix team leadership - Planning and streamlining of qualifications - Commissioning & Qualification (C&Q) - CAPEX : Full qualifications (URS, FS, GMP-RA FMEA, DQ, IQ, OQ, PQ, SR) - OPEX : Requalifications (RQ) - Audits & regulatory body inspections spokesperson (Swissmedic, FDA) - support to Quality and Regulatory (changes and product filing/submission) Systems in the suite I am responsible for: Filling and Lyo Isolators, Filling line (Vials washer, Depyrogenation tunnel, Filling-stoppering machine, Capping machine, LAF), Freeze dryer, Autoclave, Parts washer, Compounding system, Freezer, Cold room, Visual inspection booths, Incubator, minor devices. Currently freelance with Numeriq AG, formerly with Capgemini Engineering.
Pharmaceutical industry - Drug product and Drug substance - DP/DS Engineering Manager of a team of 7+ direct reports (technicians, technical support engineers, interns) - Responsible for all technical aspects of a new sterile/aseptic pharmaceutical manufacturing facility - Process expert, troubleshooting, calibration and maintenance. - Leadership - Coaching - CMMS, Deviations, CAPA, Change Control, SOP, Calibration, Maintenance - Planning - Support to Commissioning & Qualification - NPI (greenfield facility) Systems in the suite I was responsible for: Manufacturing Skid, Filling line (Vials washer, Depyrogenation tunnel, Fill & Finish machines, LAF), Autoclave, VHP Pass Box, Parts washer, Facility Monitoring System (FMS), HVAC and BMS, Water systems (Reverse Osmosis PW, WFI, Clean steam), Solvent and Waste systems, TCU units, Compressed air and Nitrogen.
Pharmaceutical industry - DP NPI Project Manager with technical focus on new pharmaceutical turnkey lines and machines for sterile products "Ready to Use" (Ompi Ez-Fill) - Innovative projects. - Working in the "Engineering Systems Division" of Stevanato Group, specialized in the engineering of new products: design, production, integration of machines and lines for glass vials, cartridges, syringes. - Leadership - Technical Project management - New product introduction and development (turnkey pharmaceutical lines) - Design (mechanics, electrical, automation PLC-HMI, safety, SCADA, vision systems) - Lines Start-up and commissioning (SAT) and Qualification (IQ, OQ) - Coordination and Planning - Lifecycle management
FMCG Beverage industry (PET plastic) Project manager - Project management - Application/Sales engineering: feasibility, project specifications - Risk Management - New Product Development (NPD) and New Product Introduction (NPI) experience on processes typical of Engineering To Order (ETO) companies. - FAT tests - At customers site: installation, start-up; SAT tests. Systems/machines: - Complete bottling lines - Injection moulding machines, Stretch blow moulding machines, moulds - R&D developments