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Charlotte Gschnitzer, MSc, BSc (Dipl.Ing.), MBA Eligible to work in the US

Address: P.O Box 683538, Park City (Utah), 84068

Email : adht3r@r.postjobfree.com

Cell Phone : +1-801-***-****

Profile

Highly skilled, innovative, motivated project engineer/manager with 7 years of experience in the pharmaceutical, medical, and chemical sector. Interdisciplinary work with various global departments. Strong communication, strategic planning, coordination, and team leadership skills. Solid knowledge of GMP requirements in manufacturing areas and equipment, safety, auditing and risk analysis. Owner of projects, lead of large project teams and supervision of construction sites. Enhanced knowledge, like international business strategy, operations management, and corporate finance through MBA degree.

Main Education

2017 – 2020 MBA – Bradford University (UK)

2006 – 2012 Master’s and Bachelor’s degree Process/Industrial Engineering - University of Leoben (Austria) Work Experience

Staff Project Engineer/Manager - Janssen Pharmaceutical Companies of Johnson&Johnson (Switzerland) January 2016 – March 2020

- CAPEX projects in parenteral, solids and packing sector including cleanroom reconstruction. Large project teams of >20

- Cost calculation, assessment and creation of business cases (CARs) for new projects including feasibility studies

- Placement of orders for project, cost tracking. Negotiation with suppliers, supplier qualification, evaluation and auditing

- Preparation of project documentation (P&ID, process description, risk analysis in form of HAZOP and pFMEA and dFMEA)

- Create timelines, schedules and plan resources, lead project teams, participate in audits, prepare regulatory submissions

- Oversee construction site (responsible for work permits, safety, emergency plans). Supervision of up to 50 people on site.

- Close collaboration with production, validation team, technical operations, external planning, suppliers, product owners

- FAT, SAT of new equipment and complete DQ, IQ, OQ, PQ. Owner of COCs and CAPAs

- Follow up of timeline and project status and costs, monthly project reporting to management in form of 4Ups.

- Set-up of new standardization software Perinorm and function as admin of system. Collaboration with global sites

- Planning of pipelines, reconstruction of building and equipment, development of new equipment design. Adherence to country specific guidelines or customer requirements within the production process and design of products

- Carry out DOEs, review, write and approve SOPs

Project/Process Engineering Lead- VTU Engineering (Switzerland) August 2013 – January 2016

- Preparation, presentation, and lead of the HAZOP risk analysis of a process plant for an ammonia scrubber as part of ultra-low refrigeration- and distribution and MVK process change at DSM

- Responsible for the construction site coordination and construction site safety of a low-temperature unit at DSM

- Project regarding the improvement of the production process of methyl vinyl ketone (MVK) at DSM

- Assistance with the documentation, development, qualification, and implementation of smaller projects and production support in production in routine operations at Sandoz/Novartis

- Adaptation of production process for FDA readiness. Close collaboration with customer in the US and alignment of regulatory and customer requirements. Gap-Assessment and lead of pFMEA at Mathys

- EPCM for the construction of a stand-alone cleanroom unit at DSM

- Test qualification of an injection molding system, presentation and development of a risk analysis, examination of the existing acceptance documentation and recommendations for the improvement of the documentation structure, elaboration of the qualification documentation and execution of the qualification at Ferromatik Milacron

- Preparation of qualification and validation documents, support of the production in routine operations at Roche

- Upscaling of production process for new product within the medical device industry at Mathys

- Preparation of qualification documentation for new equipment in the medical device industry at Mathys Page 2/2

Certificates / Training Skills

Technologies

Awards Subject Company

Languages

- Leading without managerial authority - Project Management

- Machine safety - GMP/Validation/Quality

- Working in heights - Budgeting

- Qualified Trainer - Train the Trainer - Change management

- FPX - Flawless Project Execution - Engineering

- Steam condensate technology seminar - Data analysis

- GMP Training - Cross-functional team leadership

- Seminar conflict management - Operations management

- Risk Assessment und Process Safety Introduction - Communication

- Project management for middle-sized projects - Problem solving

- Quality Management - Process improvement

Procurement, Inventory, Maintenance: SAP, E-marketplace Design: AutoCAD, Visio,Acrobat

Organization, Planning: MS Project, Power Point, Excel, OneNote Operating Systems: Windows, Mac OS

Document Management: Perinorm, DocSpace, Citavi

Change Management: Trackwise

Personal Development: Workday

Data Management and Analysis: Process Book, Excel, Matlab Plant and Equipment Management: Active Directory, Siemens S6 Communication: Zoom, Skype, Outlook, IOS, Android

Bachelor Thesis 1 Treatment of Tunnel Wastewaters at the Niagara Tunnel Project

Strabag in Canada

Bachelor Thesis 2 Treatment of Tunneling Wastewaters during Construction Theoretical Work Master Thesis 1 Continuous Crystallization of ASA in a Tubular Reactor RCPE in Austria Master Thesis 2 Agile Decision-Making within the Construction Industry during Change

Sirius Minerals in UK

German: Mother language

English: Bilingual

French: Intermediate

Italian: Intermediate

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