AZConcept

Professional CV

Download pdfniagara

Nom : ZWINGELSTEIN Alain

Function : Automation specialist
Education : Electromechanical degree
Languages: French Mother language
English & German fluent, Italian Basics, Polish Basics




Professional Skills
Mr. Zwingelstein has a 30 years long experience in design, erection, start-up and validation of industrial automation systems.
He particularly developed his experience the last 17 years in the pharmaceutical domain, in design of automation and MES systems for pharma, taking in account the requirements of cGMP, GAMP and Computer System Validation.
Based on his deep knowledge of the specific constrains,  regulations and specific processes in the pharmaceutical area, he will help and support clients from conceptual up to validation phases with a global approach of the project goals.
He has worked recently in key projects for Eli Lilly, Merck MSD, Serono, Baxter, Roche, Cilag / J&J and Novartis.





JE Jacobs France
Automation Specialist since September 2004

GSK-BIO
WN170 Project: Location Wavre Belgium
Basic Design for a Green Field Freeze Dried and Liquid Vials Live Vaccine Secondary plant. Project details are confidential.

NOVARTIS
PRESTO Project: Location Switzerland
Conceptual Design for a revamping / extension of a sterile secondary facility for Lyophilized products..

NOVARTIS
MAESTRO Project: Location Switzerland
Conceptual Design for a grass root sterile secondary facility for Lyophilized and liquid products (Vials and Syringes).

RICHTER GEDEON
Debrecen Project: Location Debrecen Hungary
Conceptual, Basic and Detailed Design for a new Biotech Facility..

GSK-BIO
WN170 Project: Location Wavre Belgium
Basic Design for a Green Field Freeze Dried and Liquid Live Vaccine Secondary plant. Project details are confidential..

GSK-BIO
SA03 Project: Location “Confidential” France
Basic Design for a Green Field Freeze Dried and Liquid (Vials & Syringes) Vaccine Secondary plant. Project details are confidential.
Automation team leader and follow-up of the process package starting form inquiry up to FAT..

Pfizer
FDCE project: Puurs Belgium
Basic Design for a new Freeze Dried products facility including all activities from Raw material handling to dispensing, formulation, filling , Automatic freeze dryers loading / unloading, capping, automatic inspection, coding, leak testing and tray loading of different vials sizes. Highly integrated MES driven automation at all stages of production.
Main activities: Writing of the MES oriented Operational Descriptions and support to process equipment specification and inquiry..

Chiron
Biotech Plant: Location Siena Italy
Start-up of the Centrifugation unit and Batch Control system.











Previous experiences

Steril A.G. Bâle (Foster Wheeler Group)
Automation, Instrumentation and Electrical Manager
Responsible of the Engineering Department.


Novartis
SMART Project: Singapore
Conceptual & Basic design for a new solid dosage forms production site in Singapore. MES driven production center including warehouse and automatic storage system.
Main activities were definition of the Automation concepts, elaboration of the system architecture and specification of the pharma equipment automation requirements.

Baxter
BDH2 project: Neuchâtel Switzerland
Feasibility study for the capacity expansion of a biotechnological production plant.
Main activity was elaboration of the automation expansion concept allowing a minimized impact on validation status of the existing
System.

Cilag AG Schaffhausen Switzerland
LPFx project: Schaffhausen Switzerland
Expansion of a new department in isolation technology of aseptic filling, freeze drying with in-line automatic loading / unloading system – conventional capping line.
Main activity was the Automation part of the pharma equipments.

Novartis
MARS project: Huningue France.
Conceptual & Basic Design. Revamping of an existing building for a new ointment formulation and conditioning unit.
Elaboration of the Automation user requirements. Design of the Automation system architecture. Specification of the Pharma equipments automation requirements.

Roche
GSF project: Kaiseraugst Switzerland.
Conceptual & Basic Design for a new oral solid dosage forms for high active products and isolator technology.
Definition of the Automation concepts of the warehouse, production HVAC systems. Definition of the material and container identification and tracking philosophy. Specification of the MES requirements, definition of the system architecture and specification of the pharma equipments automation requirements.

Computer Validation Standardization Project: Basel Switzerland.
Set-up of the Roche Basel site CSV “periodic review” protocol standard.
Writing and execution of a “prototype” protocol, before overall site implementation. Set-up of the final periodic review plan.

Boehringer Biberach RFA
NPHM project: Biberach RFA.
Conceptual & Basic Design for a high active oral solids forms product pilot plant.
Definition of the automation concept and system architecture for the production, HVAC, monitoring and utilities. Specification of the pharma equipment automation requirements.

Berna Biotech
Computer System Validation: Bern Switzerland
Retrospective validation of the complete vaccine site of Bern Rehag.
Elaboration of the Computer System Validation protocol templates, execution of tests, Reports, set-up of the Validation Documentation System.

Baxter Biosciences
Fill and Finish for parenteral forms : Neuchâtel Switzerland.
Project team leader for the capacity expansion and new WFI loop, Clean Steam Generation and Distribution, Clean Room Monitoring System. Specification for the automation system requirements, vendor follow-up and start-up.

Computer system Validation Project: Neuchâtel Switzerland.
Writing and execution of the Computer System validation protocols for Filling line, Stopper processor, Autoclaves, HVAC, Clean Room Monitoring, Lyophilizers and utilities of the facility.

Weimar Pharma
Computer System Validation : Rastatt RFA
Retrospective validation for a parenteral fill and finish line including utilities. (ampoules washer, sterilization tunnel, filling machine, Autoclaves, HVAC, clean utilities).
Writing and execution of the computer system validation protocols. Test execution and reporting.

Serono
WFI expansion project : Aubonne Switzerland
Expansion of the WFI production capacity, New Still and Loop extension.
Project leader for the expansion project. Specification of the automation requirements and elaboration of the functional specification for the expansion.

Lonza Visp Switzerland
Computer System Validation : Visp Switzerland
Retrospective CSV of the process control systems for the Multipurpose API production line FC6 and phosgenation line. (following activities of the Kvaerner project)
Validation Team leader.

Kvaerner Process France / Switzerland
CSV Validation Manager
CSV Team leader Switzerland.


Lonza
Validation : Visp Switzerland
Computer System Validation team leader.
Retrospective CSV of the process control systems for the Multipurpose API production lines FC2, 4, 5 and 6. and Infrastructures.
Elaboration of the Validation Master Plan. Writing the Computer System Validation SOP’s. Creation of IQ and OQ Protocol templates for DCS, PLC’s and Visualization. Writing of the testing protocols, test execution, deviation management and report writing. Set-Up of a CSV documentation System, change control procedure and deviation management.
CSV Training of Lonza employees.

Serono
Computer System Validation, P108 project: Aubonne Switzerland
Validation of a new parenteral fill and finish plant.
Computer System Validation team leader. Set-up of protocol templates, writing and execution of protocols for all equipment and utilities of the plant. (Filling line, Lyophilizers, Stopper processor, Autoclaves, HVAC, Monitoring system and clean utilities )

Foster Wheeler France
Automation Engineer

Merck MSD
MK826 project: Mirabel Riom France
New facility for large spectrum antibiotic parenteral. Formulation, filling, lyophilizing, automatic loading / unloading under isolator , capping, automatic visual inspection and packaging.
Definition of the automation concept and architecture. Specification of the HVAC, monitoring and pharma packages requirements.

Eli Lilly
BHI project: Fegersheim France
Biotechnological Human Insulin production plant
Design and specification for the Automation and instrumentation system. System architecture elaboration. Specification for pharma equipments requirements.

EMCS project: Fegersheim France
New Energy and Monitoring Control System.
Design, installation and start-up of the energy monitoring and control system for the Fegersheim Site. Remote monitoring via Minitel and pagers. Integration of the site process utilities automation.

Humulin project: Fegersheim France
Insulin formulation and conditioning facility.
Installation supervision and start-up / validation for the Automation and instrumentation systems. Pharma package automation follow-up.

Marion Merrel Dow
Research Center, Animals testing : Strasbourg
Revamping of the water loops.

Bayer
Latex project: La Wantzeneau France
Feasibility study for the latex conditioning line automation.


Ateliers Electriques de Pierrefitte
Automation & Instrument engineer


Exxon Chemical
Vistalon project: Notre Dame de Gravenchon France
Expansion of the “Vistalon” production unit.
Redaction of the “Interlocks and Security Manual” for the plant, replacement of the safety relaying devices by redundant PLC’s and monitoring systems.

Trefimetaux
High value Alloy furnaces project : Sérifontaine France
Design, installation and start-up. Integration of spectrographic analyzers and automation of alloy adjustments. C language custom development.
Design, installation and start-up for induction furnaces automation. C language custom development.

Exxon
Paramins expansion project : Notre Dame de Gravenchon France
Design, installation and start-up of the “Paramins” additives production unit.

Lubrizol
Miscellaneous revamping projects : Rouen France

Shell
Miscellaneous revamping projects: Petit Couronne France

Alicel
Wood Storage park project : Alicel Alizay France
Design installation and start-up for the new chips and barks storage and barking / cutting plant at the Alicel paper pulp plant.

Schlumberger
Laboratory revamping. Clamart France
Start-Up.

Clemmessy RFA
Automation & Instrument engineer


Technical assistance at Foster Wheeler France
Coker expansion project : Veba Oel Gelsenkirchen RFA
Coker capacity doubling. Safety and interlocking system design for heaters, turbine and compressor on “Hima” wired processors.

Korf und Fuchs
Miscelaneous Steel plants, Berlin, Lybia, USSR
Design, erection and start-up of Automation System.

Hadeed Steel
Rolling mill furnaces: Al Jubail Saudi Arabia
Commissioning and start-up.

Schelde Chemie
Nassoxydation project: Shelde-Chemie (Bayer Ciba-Geygi) Brünsbüttell RFA
Automatisation of a Chemical plant waste water treatment pilot plant. Design, Construction and Start-Up.

SAIT Saverne 67700 France
Method and launching office


Explosion proof devices construction plant : SAIT Saverne France
Work orders edition, Construction sequences, Stock management and production time control.




Employer Historian

Jacobs France : since 2004
Steril A.G. Bâle : 2000 – 2004
Kvaerner Process France (Sofresid) : 1999 – 2000
Kvaerner Process Switzerland : 1998 – 1999
Foster Wheeler : 1991 – 1998
Ateliers Electriques de Pierrefitte : 1985 – 1991
Clemmessy RFA : 1978 – 1985
SAIT : 1976 – 1977


Looking for something?

Use the form below to search the site:

Still not finding what you're looking for? Drop a comment on a post or contact us so we can take care of it!

Blogroll

A few highly recommended websites...