CV

Education

  • Secondary School, Bruck an der Leitha, 1988
  • College for Technical Chemistry, Vienna, 1992
  • Advanced College for Technical Chemistry and Environmental Analytics, Vienna, 1998

24 Years of professional experience

  • Protein purification from Fermentation, small and large scale
  • Process transfer and implementation
  • Process improvement
  • Personal Management
  • Planning and Engineering
  • Project management skills
  • Applied cGMP-Knowledge
  • Generation and execution of Quality Documents; MVP, SOP, batch records etc.
  • Generation and execution of Validation documents
  • Risk Analysis
  • Process Validation
  • Equipment Validation
  • Cleaning Validation
  • Protein purification form Bovine Plasma (large scale)
  • Plant and Equipment Maintenance

Languages

  • German mother tongue
  • English fluent

Personal Interest

  • Surfing
  • Travelling
  • Reading

Boehringer Ingelheim Austria, Vienna

(December 2013 – July 2018)
Head of Unit, Downstream Manufacturing

  • Lead a team of 15 staff
  • Purification of Proteins in the late Downstream stages, incl. filling of Drug Substance
  • Maintain the cGMP-Status of the plant
  • Maintain the validation status in regard to Equipment, Cleaning, Environment and Process
  • Process Deviations and CAPAs within the Quality system
  • Represent and participate in Audits by Regulatory Authorities and Customers
  • Manage and maintain shift/vacation planning of staff
  • Maintain and manage training and development of staff
  • Cost and budget responsibility
  • Prepare and execute CAPEX projects
  • Cooperate and execute current and project tasks with supporting units
  • Communicate facts and figures to management

NewWayZ Consulting, Auckland

(January 2012 – September 2013)
Chemical and Environmental Engineer (Freelance Consultant)

Validation Support

  • Preparation of a Risk Assessment for a Natural Health Manufacturer (Process Improvement Project)
  • Preparation and execution of Plant and Equipment Validation Documentation for a University Laboratory
  • Preparation of Plant and Equipment Validation Documentation for a Natural Health Facility
  • Preparation of Validation documentation for BMS upgrade for a Pharmaceutical Manufacturer

Engineering Support

  • Preparation of process maps for a Pharmaceutical Manufacturer
  • Preparation of Engineering documentation (Water Plant) for a Pharmaceutical Manufacturer (Factory Expansion Project)
  • Support with Technical documentation in relation to Process Vessels for a Pharmaceutical Manufacturer (Factory Expansion Project)

Tegel Foods Ltd, Auckland

(July 2011 – January 2012)
Product Improvement Engineer (contract position)

  • Improvement of manual and automated cleaning methods
  • Initiating plant improvements in relation to automated cleaning
  • Updating of cleaning procedures
  • Staff training

ICPbio International Ltd. (now MP Biomedicals New Zealand Limited), Auckland

(August 2008 – August 2010)
Process and Plant Engineer

Plant and Equipment Maintenance

  • Organizing / Executing of Maintenance and Calibration tasks for the following Equipments:

Balances
Freeze Driers (Cuddon and Labconco)
HVAC
Pressure Gauges
Pressurized Air
Process Controllers (GE)
Process Rooms, Cold Room, Freeze Container, -80degC Freezer, -20 Freezer and Fridges
Pumps
RO Water Plant (Veolia)
Temperature Monitoring, Temperature Loggers and Thermometers
Testing/Tagging of electrical Equipment
Ultrafiltration Units (KOCH and PALL)
Waste Water Treatment Plant

  • Managing of Council/Legal requirements

Finalizing Building Consent
BWOF
Trade Waste Water Disposal

  • HSNO Approved Handler

Validation Activities for the following Systems:

  • Freeze Driers (Cuddon and Labconco)
  • Freezer Container
  • RO Water Plant

Document preparation

  • Manufacturing Instructions
  • SOP’s and Validation documents
  • Drawings

Processing of the following Products derived from Bovine Plasma via Chromatographic Separation:

  • Albumin
  • Thrombin
  • Transferrin

Support Development Projects

  • Cholesterol Extraction / Purification

ICPbio Ltd. (in Receivership), Auckland

(March 2008 – August 2008) Tech Transfer Officer

  • Process transfer and implementation
  • Support of the Technical Department

Boehringer Ingelheim Austria, Vienna

(February 2006 – January 2008)
Process Implementation role
Technological Support to the Implementation Department and the Production Department

  • Support the purchasing of long lead equipment:

Chromatography columns (diameter 140-1800 mm)
Chromatography systems
UFDF systems
Filters
Mobile vessels (50-1500L)

  • Development and preparation of User Requirements (for the systems mentioned above)
  • Support the offer negotiations
  • Support during FAT
  • Support during qualification

Coordinative Work for the Production Department and Technical Department

  • Maintenance scheduling
  • Adaptation/Modification of current production facilities
  • Monitoring the budget for 5 production units

Chemgineering Planung GmbH, Vienna

(May 2001 – December 2005), Technology Consultant, GMP Specialist

11/2004 – 11/2005 NOVARTIS, Stein, Switzerland

Planning and Engineering incl.

  • Preparing of tender documents
  • Obtaining quotations
  • Conducting quotation negotiations
  • Preparing and conducting the purchase decision

For the following equipment:

  • Steam sterilizer and hot water sterilizer
  • Equipment washing machine
  • Microbiological air sampling for clean room and isolator
  • Filter test equipment
  • Production vessels (50-300L)
  • Vessels for production and clean media (WFI and AP)

Development and preparation of qualification documents

  • User Requirements
  • Risk Analysis

05/2004 – 11/2004 ABBOTT, Ludwigshafen, Germany

Planning and Engineering for:

CIP system for API-Production
WFI system
PW system
Clean steam system
Pressurized air system

Distribution system for liquid nitrogen

  • Development and preparation of User Requirements (for the systems mentioned above)
  • Development and preparation of process flow data sheets

09/2003 – 01/2004 Aventis Behring Wien, Vienna, Austria

Project Manager for qualification activities contract filling (DELTA, England)

  • Development of production schemes
  • Scheduling Activities

Development of qualification documents

  • Master documents (MVP‘s, Project execution plans, Project definition document)
  • Risk Analysis
  • Protocols for IQ, OQ und PQ
  • Final reports of qualifications

Validation coordination and execution for

  • Autoclaves
  • Filter test apparatus (PALL TRONIC)
  • Vessels
  • Bottle washing machine
  • Hot air sterilizer

05/2003 – 09/2003 Aventis Behring Wien, Vienna, Austria

Deputy Project Manager for a Qualification Project of a plant reconstruction

  • Project management and scheduling

Development of qualification documents

  • Master documents (MVP‘s, Project execution plans, Project definition document)
  • Risk Analysis
  • Protocols for IQ, OQ and PQ
  • Final reports for qualifications

Validation coordination and execution for

  • Autoclaves
  • Clean steam system
  • WFI-system
  • CIP-system
  • Compressed air system

02/2003 – 05/2003 Heumann Pharma, Feucht, Germany

Development and execution of IQ and OQ protocols

  • Equipment qualification for highly potent substances

10/2002 – 01/2003 Boehringer Ingelheim Austria, Vienna, Austria

Conceptual design for

  • CIP-System for fermentation and down-stream processing
  • WFI-System
  • PW-System
  • Clean steam system
  • Pressurized air system

09/2002 – 10/2002 Aventis Behring Wien, Vienna, Austria

  • HVAC Qualification
  • SOP- and protocol development
  • Planning and execution of smoke studies

06/2001- 07/2002 ZLB (now CSL Behring), Bern, Switzerland

  • Development of MVP
  • Risk Analysis
  • Cleaning validation for blood plasma derived products
  • Qualification coordination and execution (IQ,OQ and PQ)
  • Reviews of qualification documents and results

Boehringer Ingelheim Austria, Vienna

(September 1994 – April 2001)
Chemical Technician, Pilot Plant

  • Purification of recombinant proteins in small and large scale, planning and execution
  • Extraction and secondary recovery of proteins
  • Chromatographic methods (Ion-exchange, reversed phase HPLC, gel permeation)
  • Separations (CEPA-centrifuges and separators)
  • Refolding of proteins
  • Ultra- and Diafiltration
  • Process optimisation
  • Preparation of batch records and SOP’s (Standard Operation Procedure)
  • Process transfer and implementation for the following companies

Connetics, Palo Alto, US-CA, USA
Glaxo Smith Kline, King of Prussia, US-PA, USA

  • Up scaling of processes
  • Validation and qualification responsibilities