de
Keywords
HSE Safety Stops
SUVA
QC)
GAMP5
DQ
HVAC
ACC
COMOS
Solids
Steriles
PQ
Biotec
Smartsheets
LEAN
MDR
MedTec
Agile Project Management (SCRUM)
Risk Assessments
OQ
cGMP
GxP
GLP
FMEA
CE
EMA
Process Validation
Swissmedic
Six Sigma
Construction (FEM & Kinetic Simulation)
FDA
SLAs
ATEX
Leadership
CAPEX
21CFR Part 11
Inter-cultural experience
Documentation
Computerized System Validation
Validation & Qualification & Commissioning (Equip
Rooms
Black & White Utilities
IQ
Skills
Hard Skills:
Ten years of leadership experience with agile project management (SCRUM). Specialist for the execution of complex projects with many divergent project requirements and stakeholders with focus on quality and compliance regulatory requirements especially product launch activities. Certified specialist for six sigma projects and supply chain management. Expertise in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computerized Systems Validation (CSV) regarding regulatory requirements of Food and Drug Administration (FDA), European Medicines Agency (EMA) and Swissmedic.
Experience in LEAN Management and SIX SIGMA.
Very good inter-cultural experience through my backpacker travels from Bali to Cambodia and Vietnam to Hong Kong.
Highlights:
• MBA in Logistics and Supply Chain Management
• Six Sigma Black Belt
• LEAN Manager
Ten years of leadership experience with agile project management (SCRUM). Specialist for the execution of complex projects with many divergent project requirements and stakeholders with focus on quality and compliance regulatory requirements especially product launch activities. Certified specialist for six sigma projects and supply chain management. Expertise in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computerized Systems Validation (CSV) regarding regulatory requirements of Food and Drug Administration (FDA), European Medicines Agency (EMA) and Swissmedic.
Experience in LEAN Management and SIX SIGMA.
Very good inter-cultural experience through my backpacker travels from Bali to Cambodia and Vietnam to Hong Kong.
Highlights:
• MBA in Logistics and Supply Chain Management
• Six Sigma Black Belt
• LEAN Manager
Project history
Successes:
• Insight into the engineering work in Formula 1 through my master thesis for the Sauber Formula 1 team
• Process equipment Performance Qualifications for the product launches of Gilenya, LCI, BYL at Novartis Solids New Launch Facility WST-222
• Insight into the engineering work in Formula 1 through my master thesis for the Sauber Formula 1 team
• Process equipment Performance Qualifications for the product launches of Gilenya, LCI, BYL at Novartis Solids New Launch Facility WST-222
Local Availability
Open to travel worldwide
Now available worldwide.
Other
Professional Career
Master thesis MBA (04/2018– 12/2018)
Middlesex University, London (UK)
•
„LEAN in the Formula 1“ (Sauber Formula 1 Team)
Project Engineer & Operational Business Excellence (06/2017 – 03/2018)
Novartis WST-222, Stein AG (CH)
•
Planing, design and implementation of engineering projects (CAD)
•
Constructing of process plants (CAD)
•
Tracking of Change Management Projects (ACC)
•
Improvement processes for the New Solids Launch Facility project
•
Tracking the handover meetings for the process equipment
•
Perform performance qualification of the process equipment
Compliance Manager /
Operational Business Excellence (07/2016 – 05/2017)
Novartis Campus WSJ-42, Basel (CH)
•
GAP analysis for a continuous manufacturing biotech project
Compliance Manager /
Operational Business Excellence (05/2014 – 06/2016)
F.Hoffman-La Roche AG, Building 204 / 207, Kaiseraugst / Basel (CH)
Facilities: cooling rooms, dryers, blister line Mediseal CP500
•
Qualification documents for DQ, IQ, OQ and PQ
•
Coordination or implementation of IQ, OQ and PQ tests
•
Functional risk analysis and traceability matrices
•
SOP’s
Qualification Engineer (01/2011 – 04/2014)
Novartis Wehr (DE) / Novartis Campus Basel (CH)
Equipment: Datamatrix Verifier, Uhlmann Packaging lines, De-blistering machines, Scales, Format-sets for tube fillers, Korsch and FETTE tablet presses
•
Qualification documents for DQ, IQ, OQ and PQ
•
Coordination or implementation of IQ, OQ and PQ tests
•
Calibrations in clean room laboratories
Supply Chain Manager, Traction converters (04/2009 – 01/2011)
ABB Schweiz AG, Turgi (CH)
•
Product outsourcing to China, Poland and India supporting the Local Engineering Center (LEC)
•
Performing of concepts with Sales and Product Management
•
Quality control of suppliers
Mechanical Engineer,
Engineering of advanced power electronics (09/2005 – 03/2009)
ABB Schweiz AG, Turgi (CH)
•
Constructing and planning of frequency converters
•
Product responsibility of wind turbine converters
•
Product outsourcing to Poland, India and China, as well as support for the Local Engineering Center (LEC)
•
Quality control of suppliers
Technical supervisor module and converter installation,
discrete automation and motion (08/2001 – 08/2005)
ABB Schweiz AG, Turgi (CH)
•
Planning, coordination and supervising of installation of converters
•
Quality control of the converter modules as well as of related suppliers
Employers:
Brine, Zürich (CH), Project Engineer (11/2017 – 03/2018)
Morgan Sindall, Basel (CH), Compliance Manager (03/2014 – 11/2017)
Pharmatronic AG, Pratteln (CH), Qualification Engineer (01/2011 – 04/2014)
ABB Schweiz AG, Turgi (CH), Supply Chain Manager (08/2001 – 01/2011)
Park clinic, Bad Säckingen (D), Community service janitor (08/2000 – 08/2001)
Ciba, Bad Säckingen (D), Operational employee (03/2000 – 08/2000)
Master thesis MBA (04/2018– 12/2018)
Middlesex University, London (UK)
•
„LEAN in the Formula 1“ (Sauber Formula 1 Team)
Project Engineer & Operational Business Excellence (06/2017 – 03/2018)
Novartis WST-222, Stein AG (CH)
•
Planing, design and implementation of engineering projects (CAD)
•
Constructing of process plants (CAD)
•
Tracking of Change Management Projects (ACC)
•
Improvement processes for the New Solids Launch Facility project
•
Tracking the handover meetings for the process equipment
•
Perform performance qualification of the process equipment
Compliance Manager /
Operational Business Excellence (07/2016 – 05/2017)
Novartis Campus WSJ-42, Basel (CH)
•
GAP analysis for a continuous manufacturing biotech project
Compliance Manager /
Operational Business Excellence (05/2014 – 06/2016)
F.Hoffman-La Roche AG, Building 204 / 207, Kaiseraugst / Basel (CH)
Facilities: cooling rooms, dryers, blister line Mediseal CP500
•
Qualification documents for DQ, IQ, OQ and PQ
•
Coordination or implementation of IQ, OQ and PQ tests
•
Functional risk analysis and traceability matrices
•
SOP’s
Qualification Engineer (01/2011 – 04/2014)
Novartis Wehr (DE) / Novartis Campus Basel (CH)
Equipment: Datamatrix Verifier, Uhlmann Packaging lines, De-blistering machines, Scales, Format-sets for tube fillers, Korsch and FETTE tablet presses
•
Qualification documents for DQ, IQ, OQ and PQ
•
Coordination or implementation of IQ, OQ and PQ tests
•
Calibrations in clean room laboratories
Supply Chain Manager, Traction converters (04/2009 – 01/2011)
ABB Schweiz AG, Turgi (CH)
•
Product outsourcing to China, Poland and India supporting the Local Engineering Center (LEC)
•
Performing of concepts with Sales and Product Management
•
Quality control of suppliers
Mechanical Engineer,
Engineering of advanced power electronics (09/2005 – 03/2009)
ABB Schweiz AG, Turgi (CH)
•
Constructing and planning of frequency converters
•
Product responsibility of wind turbine converters
•
Product outsourcing to Poland, India and China, as well as support for the Local Engineering Center (LEC)
•
Quality control of suppliers
Technical supervisor module and converter installation,
discrete automation and motion (08/2001 – 08/2005)
ABB Schweiz AG, Turgi (CH)
•
Planning, coordination and supervising of installation of converters
•
Quality control of the converter modules as well as of related suppliers
Employers:
Brine, Zürich (CH), Project Engineer (11/2017 – 03/2018)
Morgan Sindall, Basel (CH), Compliance Manager (03/2014 – 11/2017)
Pharmatronic AG, Pratteln (CH), Qualification Engineer (01/2011 – 04/2014)
ABB Schweiz AG, Turgi (CH), Supply Chain Manager (08/2001 – 01/2011)
Park clinic, Bad Säckingen (D), Community service janitor (08/2000 – 08/2001)
Ciba, Bad Säckingen (D), Operational employee (03/2000 – 08/2000)
