Responsible for the development and transfer of new technologies and products as well as helping the company to transition from the project model to the configured product model.Actively support the all Aseptic projects :PM , site validation and team management

ProSys specialises in the design and manufacture of containment and sampling technology to meet the changing requirements of the pharmaceutical industry. Our products include custom designed Aseptic & Containment Isolators and Sampling Equipment.SME-Aseptic Application and Manage R&D . - Have participated and lead team in over 7 site validation activity [Sanofi Toronto, Pfizer Belgium, Takeda Boston, Meira GTx London, Merck Durham USA. Sanofi Hungary, Merz therapeutics_Frankfurt etc]- Have run successful SAT, IQ/OQ and calibration activities in GMP siteso Executed several Cycle Development on customer sites which includes cleaning validation, load studies, Temperature mappingo Use of Biological and chemical indicators to prove the decontamination efficacy- Developed incubators for vaccine filling isolators o Used Iso 17025 standard to validate the incubatorso Multiple Type K and Type T thermocouple used during validationo Managing temperature and RH data using Chart recorder – 21CFR Part 11 complianto Active and passive mixing of air to achieve uniformity and accuracy of temperature in closed enclosures- Glove and isolator Leak testing – pressure decay method- Designed location and probes for environment monitoring to verify room grade o Viable monitoring - active and passive monitors compliant with ISO 14698o Particle Monitoring to verify Grade A/B area using air samplers - Creating equipment drawing using Solidworks and AutoCAD – GA and PID drawings- Participate in Client Process and Product Risk Assessment- FMEA

-Business Development Activity >Generating leads >Qualifying prospective customer >Initial meetings with the client- Conducting design review meetings- Understanding the customer requirement and providing containment solutions- Preparing detailed quotation with CAD drawings

- Initial Product Development Design- Develop user requirement specification- Assist quotation process which includes quote drawings and product description write up.- Identify new customers and conduct introduction meetings- Support project management activities

- To create engineering drawings and bills of materials to agreed timescales and to support production in the purchase of components and the manufacture of the products- Participate in design reviews, production feedback and client progress meetings.- Responsible for resolution of Technical issues in a timely manner to meet project schedule requirements- Contribute to and/or manage project plans, objectives and budgets.- Maintain awareness of current technological developments and accepted industry standards.- Responsible for delivery of assigned tasks to budget cost and program.- Responsible for technical content of assigned work.- Work with sales team to help deliver competitive solutions to the Industry

As a design engineer my responsibilities were-Making solid carbide tool drawings-Communicating with customers to understand the requirements-NX 7.5 - 3D Modelling-Team Center 8-Auditing internal processes for ISO 9001, ISO 14001 and OHSAS 18001 standards-Special purpose machining-Active involvement in SPC and Continuous improvement processes.-Maintaining design documents such as risk assessment, FMEA etc-AS 9100-New Product Development-Member of Go-Green campaign at GW India. This involved reducing carbon emission and encouraging cycling (Cycle every day to office)