Hasan Okumus

Experience

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  ASML

  Jan 2000 - Jan 2002

  C&T system analyst & CFD specialist

  Contributed to the development of products by designing, creating and testing, (sub-) systems within the restrictions imposed by system specifications, costs and planning considerations.• Translate high level performance requirements to specifications of the thermal architecture of a (sub­) system.• Specify, analyze and support thermal designs and/or coordinate that analysis are done.• Construct test plans of modules in order to verify specifications of modules• Responsible for generating proper thermal designs and tests plans to safeguard thermal performance• Responsible for the proper documentation of specifications, supporting (CFD) calculations, and tests Show less

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  Miniplants

  Jan 2004 - Dec 2007

  Sales engineer

  Responsible for implementing all business-building and relationship-building expectations with uniquely assigned accounts and customers in the (bio-) pharmaceutical industry. • Determined the cost and pricing of proposals and bids.• Worked closely with company executives to identify new business opportunities• Securing the technological competitiveness and healthy growth. • Negotiated details of contracts and payments and prepared sales contracts. • Selling advanced machinery; Clean in Place Units CIP, Bio-reactors, Filter-skids and custom specific installations.• Selling multi-disciplinary engineering projects; Feasibility, basic design and detailed engineering and Validation studies Show less

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  Besi Netherlands B.V.

  Jan 2007 - Dec 2007

  Product / New Business Development Consultant (Independent through Massui)

  I've performed a business opportunity study for a NASDAQ traded supplier of advanced machinery for the semiconductor industry.The first objective was to perform a business opportunity study in medical market for the whole range of their products. As result of using the unique Massui Method the opportunities could be presented in a total overview per division in one matrix format. The second objective was to translate the obtained data to a system design specification for the new generation machines. Show less

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  Flextecs BV

  Jan 2008 - Feb 2011

  Sr. Account Manager

  A company who delivers equipped skilled teams for a wide range of technical services (HVAC mounting, welding and Insulation-work) in the main technical industries• Built relationships with key industry insiders. • Analyzed client requirements, to identify new services, created a business plan and drove strategy development. • Determined staffing requirements and interviewed, hired new employees. • Safety Inspections (VCA) & Supervising critical projects

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  Massui

  Feb 2011 - now

  Massui is a full service engineering services provider in the bio-pharmaceutical industry. Our main activities are- System Design & Development- Commissioning & qualification services- Project Management- Construction Management- cGMP Consultancy ServicesMassui also offers product- and business development activities. For more info please visit our website www.massui.com

  • Director

    Jan 2011 - now

  • Managing Director

    Feb 2011 - Jul 2023
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  Sanquin

  Oct 2013 - Mar 2014

  Engineer Mechanical

  Maintenance consultant in clean utilities in the GMP maintenance upgrade project for improving the maintenance organization in compliance with latest FDA inspection. Sanquin is specialized in the fractionation of blood plasma and the manufacturing of plasma derivatives.• Support the project team in the development of new maintenance approach. • Execute maintenance walk-downs and improve technical documentation. • Advise on maintenance strategies• Prepare Maintenance Execution Protocols (MEPs) Show less

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  Teva Pharmachemie

  May 2014 - Sept 2014

  Lead Commisioning Engineer

  Lead commissioning engineer of a relocated Inhalation Capsule Production (ICP) area within the TEVA Facility at Haarlem.• Commissioning execution of a new HVAC system • Commissioning execution of an ISO8 clean room facility• Setting up and execution of a commissioning plan for an# ICP production equipment (existing & new).# HVAC system ICP facility# ICP Clean room ISO8 facility• Support the QA Department with Change Control activities• Support the Validation Department with the requested GEP and GMP V-Engineering documentation deliverables. • Management activities; # Coordinate and supervise engineering activities with external subject matter experts in the mentioned expertise areas.# Coordinate the engineering documentation approval process throughout the responsible departments • Consulting activities; # Reviewing critical design changes and supervise on performed preliminary engineering studies.# Analyze Building Management System data and propose and plan cleanroom climate control optimalisation adjustments• Maintenance Consulting# Advise on maintenance strategies for the newly installed equipment# Setting up maintenance plan and maintenance execution protocols (ICP production Equipment & HVAC system) Show less

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  Smith & Nephew

  Dec 2014 - Jul 2023

  Sr. Engineer / Project Manager (Freelance GxP consultant through Apple Tree)

  Sr. Engineer & Project Manager of a Collagenase Production Facility site expansion and GMP renovation upgrade program.Area of Priorities:• Qualification (IOQ, PQ) of GMP installations (e.g. HVAC and production cleanrooms) • Development of GMP protocols and system summary reports• Preliminary Design update of a site fire suppression system (e.g. URS)• GMP Facility process & sewer drain redesign improvements and project execution; flood & microbiological ingress protection by backflow prevention system installation Management Activities:• Project budget approvals, PO and new vendor approvals• Construction management and supervision • Project documentation control (permissions, inspections, as-built drawings, specifications• Coordination of engineering documentation approval processEngineering Activities:• Provide engineering support and technical advice• Develop & review of (GMP) V-model Engineering documentation deliverables e.g. URS, SAT, P&ID, SOP’s and equipment specific data sheets, • Setting Up RFQ’s for vendors based on URS´s GEP Consulting activities; • Review of critical design changes• Advise on maintenance strategies• Setting up maintenance plan and maintenance execution protocols • Develop and execution of commissioning engineering documentationsGxP Consulting activities• Develop/review of Quality Engineering Documentation’s (e.g.) • Impact / Critically Assessment SOP’s• IOQ, PQ Validation protocols and summary reports• QA approval Memo’s• Open CR and follow-ups• Revising of actual SOP’s in compliance with cGMP guidelines. Show less