MES of Werum , PASX, BioMES
Aktualisiert am 22.11.2023
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 14.11.2023
Verfügbar zu: 100%
davon vor Ort: 5%
MBR Design
ESP creation
PAS-X Expert
MES configuration
Go-Live support/Hypercare
OQ Tests IQ and CSV MINT
Deutsch
Verhandlungssicher
English
Verhandlungssicher
Französisch
Muttersprache

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2 years 7 months
2022-05 - now

PAS-X Expert/ MBR Design

Senior PAS-X V3 Specialist
Senior PAS-X V3 Specialist

Nestle MBRs Design, Reviews, Improvement Setup

  • Support in implementation in food recipe, with Werum Pas-X (Version 2.1.8) 
  • Design of MBR and ESP in PAS-X/MES (approximatively 500 MBRs/ESP)
  • Processing of training matrix and training of Super user and system admins
  • Cutover preparation and Main partner in Handling with Werum/Frontwell Solutions
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface departments 
  • Input Updates and project timeline care & coordination/ development of work around solutions 
  • Backup-management and Go-Live support/Hypercare

Solcom GmbH
Osthofen in Germany
12 years 11 months
2012-01 - now

Central Equipment Management

Laboratory & Maintenance engineer
Laboratory & Maintenance engineer

Central Equipment Management of the facility with equipment preparation for several productions 

  • Ultra high vacuum Beam line WERA in the Photo-emission Particles accelerator ANKA
  • Troubleshooting und fixing of electric, electronic and mechanical devices Sample preparations and running of measurement experiences Planning and execution of the WERA beamline cabin extension

KIT - Karlsruhe Institute of Technology
Karlsruhe, Germany
6 months
2023-04 - 2023-09

Supply Chain Business Technology for a multinational pharmaceutical enterprise

PAS-X Next-Gen Product Owner for Europe
PAS-X Next-Gen Product Owner for Europe
  • Support carve out the product vision and Collaborate with cross-functional team to define product requirements; drives product line vision and ensuring development and maintenance of a multi-generation product strategy
  • Prioritization of product demand & backlog ? understand economic models to manage prioritization and applies systems thinking o Generation of key user insights and development hypothesis on solutions, support of definition of success criteria for products
  • Creating and owning product roadmap including collaboration with local site-based product owners to rationalize and standardize the product line, collaboration with TS, RD&E, Architecture teams in defining future product deployment strategies aligned with our Next Generation Architecture
  • Monitoring of performance: Work with partners to ensure availability and performance requirements are understood and drives the team to identify issues and solutions. Driving the team to ensure that all are working towards a common goal, ultimately delivering value
  • Sprint Planning, sprint review, include business/stakeholders in product reviews to gain direct feedback, definition of acceptance criteria definition, and scope for MVP and participation in scrum on scrum rite and retrospectives
  • Participating in retrospectives monitoring sprint metrics, release metrics, and usability test results, prioritizing functionality for release, managing project (oversight), scope and issue resolution
  • Partnering with project manager, scrum master, business process owner to drive alignment on goals and objectives, working closely with all stakeholders including client TS partners to ensure that deployed solutions are efficient, effective and support the business process goals and objectives across the enterprise
  • Taking responsibility for completion of process and system documentation, communication of progress and status, ensuring adoption: continuously thinking of the product to ensure that the next iteration is what the users need
  • Connecting with industry organizations and vendors: to stay current on developments and challenges of potential solutions and architectures
Hamlyn William, London, England
Remote from Germany, Europe
4 months
2023-01 - 2023-04

Development of design relevant concepts

Lead Senior Project Engineer, PAS-X Expert/ MBR Designer, Lead Senior MES Designer
Lead Senior Project Engineer, PAS-X Expert/ MBR Designer, Lead Senior MES Designer
  • Development of design relevant concepts, projects-related alignments and arrangements with the project team and interface department automation peers
  • MBR and GMBR Design for Blister and Bottles packaging lines
  • Mentoring-Training and support of junior MBR designers
NNIT Switzerland AG
Switzerland
7 months
2022-06 - 2022-12

Perform process mapping from existing Paper MBR

PAS-X Expert/ MBR Designer, Senior BioMES Designer
PAS-X Expert/ MBR Designer, Senior BioMES Designer
  • Perform process mapping from existing Paper MBR in collaboration with SMEs, MBR designers, Vendors and company automation peers
  • MBR and GMBR creation for different Suites
  • Collaboration with Automation Engineer to integrate Equipment Interfaces to designed MBR
  • Collaborate with CSV Engineer to define Test Protocol
  • Performing formal validation of MBR with CSV Engineer & future Users
NNIT Switzerland AG
Basel, Switzerland
10 months
2022-03 - 2022-12

Design of MBR and ESP in PAS-X/MES

Senior Project MES Lead, PAS-X Expert/ MBR Design, Senior PAS-X V3 Specialist
Senior Project MES Lead, PAS-X Expert/ MBR Design, Senior PAS-X V3 Specialist
  • Support in implementation in food recipe, with Werum PAS-X (Version 3.1.8)
  • Design of MBR and ESP in PAS-X/MES (approximatively 500 MBRs/ESP)
  • Processing of training matrix and training of Super user and system admins
  • Cutover preparation and Main partner in Handling with Werum/Frontwell Solutions
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface departments
  • Input Updates and project timeline care & coordination/ development of work around solutions
  • Backup-management and Go-Live support/Hypercare
Solcom GmbH
Reutlingen, Deutschland
1 year 3 months
2021-07 - 2022-09

PAS-X Expert/ MBR Design

Senior BioMES Designer
Senior BioMES Designer

Focused Factory Cell Culture MBRs Design, Reviews, Improvement Setup

  • Support in product implementation in Large Scale Cell Culture, with Werum Pas-X (Version 3.2.4) 
  • Design of MBR and ESP in PAS-X/BioMES (approximatively 200 MBRs/ESP)
  • MBR Design, creation of ESP, mainly for generic activities (Calibration, cleaning operations-CIP/SIP, etc.)
  • Analysis, improvements, updates of existing MBRs/ESPs through Jira system items tasks, parametrization of DCS BFs, MBRs Reviews and revisions
  • Processing of tasks packages on MBRs/ESPs assigned by Designer from unit / Compliance with BI internal requirements for MBR standardization 
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface departments

auf Anfrage
Vienna, Austria
6 months
2021-11 - 2022-04

Test scripts support for PAS-X V3.2

CSV Test Engineer MBR Designer
CSV Test Engineer MBR Designer

Test scripts support for PAS-X V3.2 Deployment on two different productions, Creation, and running of tests scripts for a Execution and System Qualification, Integration Testing for multinational pharmaceutical enterprise

  • Tests scripts authoring and creation
  • Master Data configuration inclusive Rights & Roles
  • Tests scripts GMBR and tests execution
  • Tests scripts MBR and tests execution

Pharmaceutical enterprise
Darmstadt, Germany
3 months
2022-01 - 2022-03

PAS-X Expert/ MBR Design

Senior MES Designer
Senior MES Designer

Library Elements - MBRs Design, Improvement Setup

  • MBR Design, creation of ESP, mainly for generic activities internal requirements for MBR standardization 
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface department

Hamlyn-William
Paris in France
9 months
2020-12 - 2021-08

Implementation of a new system

MES Senior Engineer
MES Senior Engineer

Implementation of a new system, GMBRs Design, Reviews, Setup, Execution and System Qualification and Integration Testing for multinational pharmaceutical enterprise, Alcala and Aprilia in Italy.

  • MBR (Master recipe) design, verification, updates and improvement 
  • Mentoring and support of a new MES system implementation 
  • GMBR Testing, Review, updates and improvement 
  • Data management (export/import) of system objects between the several system environments (Sbx, Dev, Q, ) 
  • Manufacturing Interface integration tests: MINT Tests 
  • Manufacturing operational qualifications tests: OQ Tests

Alcala and Aprilia
Spain/Italy
7 months
2020-06 - 2020-12

GMBRs Design

MES Senior Engineer
MES Senior Engineer

GMBRs Design, Reviews, Setup, Execution and System Testing for a multinational pharmaceutical enterprise

  • MBR (Master recipe) design, verification, updates and improvement 
  • Mentoring and support of a new MES system implementation 
  • GMBR Testing, Review, updates and improvement 
  • Data management (export/import) of system objects between the several system environments (Sbx, Dev, Q, ) 
  • Manufacturing Interface integration tests: MINT
  • Manufacturing operational qualifications tests: OQ 
  • Training & Coaching activities. MEs and Trainer trainings

pharmaceutical enterprise
Costa Rica-Guayama
9 months
2019-09 - 2020-05

Business Process Assessment

MES Engineer
MES Engineer

Business Process Assessment, System setup and Weighing & Dispense MES recipes for a multinational pharmaceutical enterprise, CAN-Montreal.

  • Business process assessment As-is and To-be 
  • Weighing and Dispense Setup und recipes design 
  • MBR (Master recipe) design, verification, updates and improvement 
  • Double active ingredients management in system 
  • Mentoring and support of a new MES system implementation - Trainings for clients and operators 
  • Process testing, updates and improvement 
  • Prototype GMBR setting and creation 
  • System specification configuration for global sites

pharmaceutical enterprise
CAN-Montreal
4 months
2019-02 - 2019-05

Pilot-Plant, Research & Development for MES recipes improvement

MES Engineer
MES Engineer

Pilot-Plant, Research & Development for MES recipes improvement und updates for a multinational pharmaceutical enterprise, CH-Stein.

  • MBR (Master recipe) design, verification, updates and improvement 
  • Library Elements design for the master recipe and their improvements 
  • Tests executions, validation and documentation 
  • Process testing, updates and improvement

pharmaceutical enterprise
CH-Stein
3 months
2018-03 - 2018-05

Implementation project of a MES

MES Engineer
MES Engineer

Implementation project of a MES (Werum PAS-X V3.1.8) at the site of a multinational (top 10) pharmaceutical enterprise, ITA-Verona.

  • MBR Design support & MBR technical verification 
  • Master Data set-up and verification 
  • Data management (export/import) of system objects between the several system environments (Dev, Q, P)

pharmaceutical enterprise
ITA-Verona
1 year
2017-01 - 2017-12

Deployment phase for the implementation of a MES

MES Engineer
MES Engineer

Deployment phase for the implementation of a MES at the site of the Consumer Health unit of a multinational pharmaceutical enterprise (top 10), CH-Nyon.

  • MBR Design support & MBR technical verification 
  • Master Data set-up and verification 
  • Development, coordination & verification of the process and equipment specific parameter value lists (internal as well as external parameters) as components for the GMBR design
  • Data management (export/import) of system objects between the several system environments (Dev, Q, P)
  • SAT test support

pharmaceutical enterprise
CH-Nyon

Aus- und Weiterbildung

Aus- und Weiterbildung

1989 - 1996:

Université du Benin : Lomé, Togo

Agricultural Engineer: Diploma


Endorsed Service Partnership (ESP Certification):

PAS-X V3.1.8 Professional Characteristics & Order Network Training

  • Introduction of order network
  • Administration of Characteristics (CX)
    • CX definition
    • CX administration for materials
    • CX administration for equipment
  • Parametrization of CX within master recipe
    • Set CX Basic Function
    • Set CX with an Activity
  • Batch record execution
    • Write CX values to equipment
    • Propagate CX values between orders


PAS-X V3.1.8 Professional Libraries & GMBRs Training

  • Libraries
    • Library Element Creation
    • Usage of Library Elements
    • Library element formula variables
    • Life cycle management
  • Generic Master Batch Records
    • GMBR Creation
    • Administration of parameters
    • Creation of parameter value lists (PVL)
    • Life cycle management


PAS-X V3.1.8 System Administration Training

  • User Administration
  • Rights Management
  • Message Administration
  • CP Info
  • PAS-X Configuration
  • GUI Configuration
  • Multi Languages
  • System Monitoring
  • Printing & Reporting
  • Audit Trail


PAS-X V3.1.8 Professional Equipment Management Training

  • Equipment management
  • Equipment Classes & Types
  • Administration of equipment items
  • State diagrams
  • Compatibility rules
  • Equipment counter configuration
  • Equipment logbook
  • Equipment usage in master recipe
  • Using the equipment library


PAS-X V3.1.8 Professional Material Flow Training

  • Material Master Data
  • Material handling
  • Material Flow within MBR
    • Bill of Material
    • Quantification Types
    • Automated material flow
    • Inventory creation


PAS-X V3.1.8 Professional Weighing & Dispensing Training

  • Weighing configurations
  • Weighing execution
  • Weighing modes
  • Inventory adjustments
  • Yield weighing


WERUM Software & Systems PAS-X V 3.1.6 Advanced Training (Karlsruhe, Germany)

  • Order management, Order preparation, EBR execution V3.1.6
  • Material and batch management, WMS storage units V3.1.6
  • MBR Design ? advanced V3.1.6
  • ERP interfaces V3.1.6
  • System administration and user?s management
  • MES project structure and deliverables, project validation roles and responsibilities


MBR creation & verification SOP training- MANDATORY prior to formal verification with Werum SME

  • Short summary of the special verification situation in Bulk (SSOL & LIQ): split between business process verification & technical verification
  • Training of MBR creation & verification SOP
  • Evaluation of formally verified GMBRs / PMBRs (packaging) in order to assess the gap


WERUM Software & Systems PAS-X 3.1.8 Gap Training session with Werum SME

  • Mastering the specifics of the project and the improvements upgrades of Werum PAS-X V3.1.5 to PAS-X V3.1.8


WERUM Software & Systems PAS-X V 3.1.8 Basic Training, GER-Karlsruhe

  • PAS-X Concept & User Interface
  • Master Data Management
  • Equipment
  • Material
  • Master Batch Records
  • MBR Designer
  • Material Flow
  • Use of Equipment
  • Weighing & Dispensing


SAP PP PI-Sheets with XSteps Training, GER-Karlsruhe

  • PI-Sheet Define Process
  • PI-Sheet Implementation Process
  • Introduction into Key concepts for PI-Sheets with examples:
    • Digital signatures
    • Functional Blocks
    • Valuation Symbols
    • Etc?
  • Introduction into key transactions for PI-Sheets
  • Governance of an existing set of XSteps and PI-Sheets
  • Archiving and EBR
  • PI-Sheet Examples in Detail
    • Production
    • Packaging


C++, Programming language (FTU, Karlsruhe, Germany)

  • Access control flow of class elements, constructors and destructors
  • Function Operator and Conversion Overloading
  • Inheritance and virtual functions
  • Functions and Template classes
  • Handling of exception situations
  • Input and output (I/O) streams


Oracle & SQL language Training (Demos, Paris, France)

  • Data Warehouse design, implementation, Good working knowledge of the Structured Query Language
  • Understand the fundamental and core concepts of relational databases
  • Create reports of sorted and restricted data
  • Control privileges at the object and system level
  • Create indexes and constraints; alter existing schema objects
  • Create and query external tables
  • Writing and implementing scripts in SQL
  • Conceptual experience designing data warehouses
  • Practical experience implementing and maintenance experience


LINUX: Operating System I, II & III (FTU, Karlsruhe, Germany) Linux III? WINDOWS ? Integration through SAMBA

  • SAMBA installation
  • Directory release with SAMBA
  • Printer release with SAMBA
  • User-dependent administration of Home directories under SAMBA
  • LINUX as WINS


Linux II- Installation and operation

  • Linux-Distribution
  • Linux Installation in der PC-Plattform
  • Kernel generation
  • Boot-Manager
  • Linux-systems configuration with YaST2
  • Manual configuration
  • User administration
  • Software Installation, distribution and update
  • Central Data retention
  • Data security
  • Security Aspects


Linux, I- Fundamentals

  • Linux as Desktop operating system
  • Linux Distribution
  • Shells and the command lines interfaces
  • Working with and change different shells
  • Linux Data system construction
  • The most important commands
  • Data system authorizations and their administration
  • User creation
  • Visual Editor
  • Communication with other computers
  • X Windows System (X11)
  • Graphic Interface KDE 3.1


Transmission of electron microscopy - Fundamental aspects and results - Interpretation of the results (CNRS, Vitry sur Seine France)

  • TEM and Characterization of materials
  • Instrument and microscopy principles
  • Electrons-matter interactions
  • Geometric crystallography and Fourier transformation
  • Rapid electrons scattering
  • Electronic diffraction and image contrast
  • High resolution imaging and chemical analysis by EDX
  • Electron Energy Loss Spectroscopy in Transmission electron microscopy


Transmission of electron microscopy - Advanced Training and computer analysis of the results (CNRS, Villeurbanne. France)

  • Diffraction and crystal symmetry
  • Artefacts and Image Processing
  • Crystallography and international tables
  • Emission and detection of X-Rays EDS, WDS
  • Acquisition and identification of spectra
  • Spatial resolution and accuracy
  • Quantification and chemical mapping
  • Contrast in METC and Fresnel contrast
  • Scattering and electronic diffraction


Scanning tunneling Near-Field Optical Microscopy (CNRS, Lille France)

  • STM pointer Operation
  • Current tunnel and effect tunnel
  • STM principles in different constants parameters
  • Instrumentation
  • Control Loop
  • Scanner and vibration isolation
  • Point to surface approach and the STM pointer
  • STM Applications
  • STM pictures and topography / Electronic effects
  • Spectroscopy STM and LDOS
  • Field emission and Nano manipulation

Kompetenzen

Kompetenzen

Top-Skills

MBR Design ESP creation PAS-X Expert MES configuration Go-Live support/Hypercare OQ Tests IQ and CSV MINT

Produkte / Standards / Erfahrungen / Methoden

Profile:

  • Experience in Pharma Industry +6 years


Coaching Experience:

2011 - 2021

Place of work: GER- Karlsruhe
Role: Founder of the Coaches & Counsellor Network: Association des coaches et conseillers

Customer: gladly on request


Tasks:

  • with the following main projects to date 
  • Group coaching and conferences in Germany & Africa (Togo, Ivory Coast) 
  • Creation of online products (e.g. Empreintes du Succès (www.empreintesdusucces.com) 
  • One2one coaching 

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2 years 7 months
2022-05 - now

PAS-X Expert/ MBR Design

Senior PAS-X V3 Specialist
Senior PAS-X V3 Specialist

Nestle MBRs Design, Reviews, Improvement Setup

  • Support in implementation in food recipe, with Werum Pas-X (Version 2.1.8) 
  • Design of MBR and ESP in PAS-X/MES (approximatively 500 MBRs/ESP)
  • Processing of training matrix and training of Super user and system admins
  • Cutover preparation and Main partner in Handling with Werum/Frontwell Solutions
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface departments 
  • Input Updates and project timeline care & coordination/ development of work around solutions 
  • Backup-management and Go-Live support/Hypercare

Solcom GmbH
Osthofen in Germany
12 years 11 months
2012-01 - now

Central Equipment Management

Laboratory & Maintenance engineer
Laboratory & Maintenance engineer

Central Equipment Management of the facility with equipment preparation for several productions 

  • Ultra high vacuum Beam line WERA in the Photo-emission Particles accelerator ANKA
  • Troubleshooting und fixing of electric, electronic and mechanical devices Sample preparations and running of measurement experiences Planning and execution of the WERA beamline cabin extension

KIT - Karlsruhe Institute of Technology
Karlsruhe, Germany
6 months
2023-04 - 2023-09

Supply Chain Business Technology for a multinational pharmaceutical enterprise

PAS-X Next-Gen Product Owner for Europe
PAS-X Next-Gen Product Owner for Europe
  • Support carve out the product vision and Collaborate with cross-functional team to define product requirements; drives product line vision and ensuring development and maintenance of a multi-generation product strategy
  • Prioritization of product demand & backlog ? understand economic models to manage prioritization and applies systems thinking o Generation of key user insights and development hypothesis on solutions, support of definition of success criteria for products
  • Creating and owning product roadmap including collaboration with local site-based product owners to rationalize and standardize the product line, collaboration with TS, RD&E, Architecture teams in defining future product deployment strategies aligned with our Next Generation Architecture
  • Monitoring of performance: Work with partners to ensure availability and performance requirements are understood and drives the team to identify issues and solutions. Driving the team to ensure that all are working towards a common goal, ultimately delivering value
  • Sprint Planning, sprint review, include business/stakeholders in product reviews to gain direct feedback, definition of acceptance criteria definition, and scope for MVP and participation in scrum on scrum rite and retrospectives
  • Participating in retrospectives monitoring sprint metrics, release metrics, and usability test results, prioritizing functionality for release, managing project (oversight), scope and issue resolution
  • Partnering with project manager, scrum master, business process owner to drive alignment on goals and objectives, working closely with all stakeholders including client TS partners to ensure that deployed solutions are efficient, effective and support the business process goals and objectives across the enterprise
  • Taking responsibility for completion of process and system documentation, communication of progress and status, ensuring adoption: continuously thinking of the product to ensure that the next iteration is what the users need
  • Connecting with industry organizations and vendors: to stay current on developments and challenges of potential solutions and architectures
Hamlyn William, London, England
Remote from Germany, Europe
4 months
2023-01 - 2023-04

Development of design relevant concepts

Lead Senior Project Engineer, PAS-X Expert/ MBR Designer, Lead Senior MES Designer
Lead Senior Project Engineer, PAS-X Expert/ MBR Designer, Lead Senior MES Designer
  • Development of design relevant concepts, projects-related alignments and arrangements with the project team and interface department automation peers
  • MBR and GMBR Design for Blister and Bottles packaging lines
  • Mentoring-Training and support of junior MBR designers
NNIT Switzerland AG
Switzerland
7 months
2022-06 - 2022-12

Perform process mapping from existing Paper MBR

PAS-X Expert/ MBR Designer, Senior BioMES Designer
PAS-X Expert/ MBR Designer, Senior BioMES Designer
  • Perform process mapping from existing Paper MBR in collaboration with SMEs, MBR designers, Vendors and company automation peers
  • MBR and GMBR creation for different Suites
  • Collaboration with Automation Engineer to integrate Equipment Interfaces to designed MBR
  • Collaborate with CSV Engineer to define Test Protocol
  • Performing formal validation of MBR with CSV Engineer & future Users
NNIT Switzerland AG
Basel, Switzerland
10 months
2022-03 - 2022-12

Design of MBR and ESP in PAS-X/MES

Senior Project MES Lead, PAS-X Expert/ MBR Design, Senior PAS-X V3 Specialist
Senior Project MES Lead, PAS-X Expert/ MBR Design, Senior PAS-X V3 Specialist
  • Support in implementation in food recipe, with Werum PAS-X (Version 3.1.8)
  • Design of MBR and ESP in PAS-X/MES (approximatively 500 MBRs/ESP)
  • Processing of training matrix and training of Super user and system admins
  • Cutover preparation and Main partner in Handling with Werum/Frontwell Solutions
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface departments
  • Input Updates and project timeline care & coordination/ development of work around solutions
  • Backup-management and Go-Live support/Hypercare
Solcom GmbH
Reutlingen, Deutschland
1 year 3 months
2021-07 - 2022-09

PAS-X Expert/ MBR Design

Senior BioMES Designer
Senior BioMES Designer

Focused Factory Cell Culture MBRs Design, Reviews, Improvement Setup

  • Support in product implementation in Large Scale Cell Culture, with Werum Pas-X (Version 3.2.4) 
  • Design of MBR and ESP in PAS-X/BioMES (approximatively 200 MBRs/ESP)
  • MBR Design, creation of ESP, mainly for generic activities (Calibration, cleaning operations-CIP/SIP, etc.)
  • Analysis, improvements, updates of existing MBRs/ESPs through Jira system items tasks, parametrization of DCS BFs, MBRs Reviews and revisions
  • Processing of tasks packages on MBRs/ESPs assigned by Designer from unit / Compliance with BI internal requirements for MBR standardization 
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface departments

auf Anfrage
Vienna, Austria
6 months
2021-11 - 2022-04

Test scripts support for PAS-X V3.2

CSV Test Engineer MBR Designer
CSV Test Engineer MBR Designer

Test scripts support for PAS-X V3.2 Deployment on two different productions, Creation, and running of tests scripts for a Execution and System Qualification, Integration Testing for multinational pharmaceutical enterprise

  • Tests scripts authoring and creation
  • Master Data configuration inclusive Rights & Roles
  • Tests scripts GMBR and tests execution
  • Tests scripts MBR and tests execution

Pharmaceutical enterprise
Darmstadt, Germany
3 months
2022-01 - 2022-03

PAS-X Expert/ MBR Design

Senior MES Designer
Senior MES Designer

Library Elements - MBRs Design, Improvement Setup

  • MBR Design, creation of ESP, mainly for generic activities internal requirements for MBR standardization 
  • Development of design relevant concepts, projects-related meetings and arrangements with the project team and interface department

Hamlyn-William
Paris in France
9 months
2020-12 - 2021-08

Implementation of a new system

MES Senior Engineer
MES Senior Engineer

Implementation of a new system, GMBRs Design, Reviews, Setup, Execution and System Qualification and Integration Testing for multinational pharmaceutical enterprise, Alcala and Aprilia in Italy.

  • MBR (Master recipe) design, verification, updates and improvement 
  • Mentoring and support of a new MES system implementation 
  • GMBR Testing, Review, updates and improvement 
  • Data management (export/import) of system objects between the several system environments (Sbx, Dev, Q, ) 
  • Manufacturing Interface integration tests: MINT Tests 
  • Manufacturing operational qualifications tests: OQ Tests

Alcala and Aprilia
Spain/Italy
7 months
2020-06 - 2020-12

GMBRs Design

MES Senior Engineer
MES Senior Engineer

GMBRs Design, Reviews, Setup, Execution and System Testing for a multinational pharmaceutical enterprise

  • MBR (Master recipe) design, verification, updates and improvement 
  • Mentoring and support of a new MES system implementation 
  • GMBR Testing, Review, updates and improvement 
  • Data management (export/import) of system objects between the several system environments (Sbx, Dev, Q, ) 
  • Manufacturing Interface integration tests: MINT
  • Manufacturing operational qualifications tests: OQ 
  • Training & Coaching activities. MEs and Trainer trainings

pharmaceutical enterprise
Costa Rica-Guayama
9 months
2019-09 - 2020-05

Business Process Assessment

MES Engineer
MES Engineer

Business Process Assessment, System setup and Weighing & Dispense MES recipes for a multinational pharmaceutical enterprise, CAN-Montreal.

  • Business process assessment As-is and To-be 
  • Weighing and Dispense Setup und recipes design 
  • MBR (Master recipe) design, verification, updates and improvement 
  • Double active ingredients management in system 
  • Mentoring and support of a new MES system implementation - Trainings for clients and operators 
  • Process testing, updates and improvement 
  • Prototype GMBR setting and creation 
  • System specification configuration for global sites

pharmaceutical enterprise
CAN-Montreal
4 months
2019-02 - 2019-05

Pilot-Plant, Research & Development for MES recipes improvement

MES Engineer
MES Engineer

Pilot-Plant, Research & Development for MES recipes improvement und updates for a multinational pharmaceutical enterprise, CH-Stein.

  • MBR (Master recipe) design, verification, updates and improvement 
  • Library Elements design for the master recipe and their improvements 
  • Tests executions, validation and documentation 
  • Process testing, updates and improvement

pharmaceutical enterprise
CH-Stein
3 months
2018-03 - 2018-05

Implementation project of a MES

MES Engineer
MES Engineer

Implementation project of a MES (Werum PAS-X V3.1.8) at the site of a multinational (top 10) pharmaceutical enterprise, ITA-Verona.

  • MBR Design support & MBR technical verification 
  • Master Data set-up and verification 
  • Data management (export/import) of system objects between the several system environments (Dev, Q, P)

pharmaceutical enterprise
ITA-Verona
1 year
2017-01 - 2017-12

Deployment phase for the implementation of a MES

MES Engineer
MES Engineer

Deployment phase for the implementation of a MES at the site of the Consumer Health unit of a multinational pharmaceutical enterprise (top 10), CH-Nyon.

  • MBR Design support & MBR technical verification 
  • Master Data set-up and verification 
  • Development, coordination & verification of the process and equipment specific parameter value lists (internal as well as external parameters) as components for the GMBR design
  • Data management (export/import) of system objects between the several system environments (Dev, Q, P)
  • SAT test support

pharmaceutical enterprise
CH-Nyon

Aus- und Weiterbildung

Aus- und Weiterbildung

1989 - 1996:

Université du Benin : Lomé, Togo

Agricultural Engineer: Diploma


Endorsed Service Partnership (ESP Certification):

PAS-X V3.1.8 Professional Characteristics & Order Network Training

  • Introduction of order network
  • Administration of Characteristics (CX)
    • CX definition
    • CX administration for materials
    • CX administration for equipment
  • Parametrization of CX within master recipe
    • Set CX Basic Function
    • Set CX with an Activity
  • Batch record execution
    • Write CX values to equipment
    • Propagate CX values between orders


PAS-X V3.1.8 Professional Libraries & GMBRs Training

  • Libraries
    • Library Element Creation
    • Usage of Library Elements
    • Library element formula variables
    • Life cycle management
  • Generic Master Batch Records
    • GMBR Creation
    • Administration of parameters
    • Creation of parameter value lists (PVL)
    • Life cycle management


PAS-X V3.1.8 System Administration Training

  • User Administration
  • Rights Management
  • Message Administration
  • CP Info
  • PAS-X Configuration
  • GUI Configuration
  • Multi Languages
  • System Monitoring
  • Printing & Reporting
  • Audit Trail


PAS-X V3.1.8 Professional Equipment Management Training

  • Equipment management
  • Equipment Classes & Types
  • Administration of equipment items
  • State diagrams
  • Compatibility rules
  • Equipment counter configuration
  • Equipment logbook
  • Equipment usage in master recipe
  • Using the equipment library


PAS-X V3.1.8 Professional Material Flow Training

  • Material Master Data
  • Material handling
  • Material Flow within MBR
    • Bill of Material
    • Quantification Types
    • Automated material flow
    • Inventory creation


PAS-X V3.1.8 Professional Weighing & Dispensing Training

  • Weighing configurations
  • Weighing execution
  • Weighing modes
  • Inventory adjustments
  • Yield weighing


WERUM Software & Systems PAS-X V 3.1.6 Advanced Training (Karlsruhe, Germany)

  • Order management, Order preparation, EBR execution V3.1.6
  • Material and batch management, WMS storage units V3.1.6
  • MBR Design ? advanced V3.1.6
  • ERP interfaces V3.1.6
  • System administration and user?s management
  • MES project structure and deliverables, project validation roles and responsibilities


MBR creation & verification SOP training- MANDATORY prior to formal verification with Werum SME

  • Short summary of the special verification situation in Bulk (SSOL & LIQ): split between business process verification & technical verification
  • Training of MBR creation & verification SOP
  • Evaluation of formally verified GMBRs / PMBRs (packaging) in order to assess the gap


WERUM Software & Systems PAS-X 3.1.8 Gap Training session with Werum SME

  • Mastering the specifics of the project and the improvements upgrades of Werum PAS-X V3.1.5 to PAS-X V3.1.8


WERUM Software & Systems PAS-X V 3.1.8 Basic Training, GER-Karlsruhe

  • PAS-X Concept & User Interface
  • Master Data Management
  • Equipment
  • Material
  • Master Batch Records
  • MBR Designer
  • Material Flow
  • Use of Equipment
  • Weighing & Dispensing


SAP PP PI-Sheets with XSteps Training, GER-Karlsruhe

  • PI-Sheet Define Process
  • PI-Sheet Implementation Process
  • Introduction into Key concepts for PI-Sheets with examples:
    • Digital signatures
    • Functional Blocks
    • Valuation Symbols
    • Etc?
  • Introduction into key transactions for PI-Sheets
  • Governance of an existing set of XSteps and PI-Sheets
  • Archiving and EBR
  • PI-Sheet Examples in Detail
    • Production
    • Packaging


C++, Programming language (FTU, Karlsruhe, Germany)

  • Access control flow of class elements, constructors and destructors
  • Function Operator and Conversion Overloading
  • Inheritance and virtual functions
  • Functions and Template classes
  • Handling of exception situations
  • Input and output (I/O) streams


Oracle & SQL language Training (Demos, Paris, France)

  • Data Warehouse design, implementation, Good working knowledge of the Structured Query Language
  • Understand the fundamental and core concepts of relational databases
  • Create reports of sorted and restricted data
  • Control privileges at the object and system level
  • Create indexes and constraints; alter existing schema objects
  • Create and query external tables
  • Writing and implementing scripts in SQL
  • Conceptual experience designing data warehouses
  • Practical experience implementing and maintenance experience


LINUX: Operating System I, II & III (FTU, Karlsruhe, Germany) Linux III? WINDOWS ? Integration through SAMBA

  • SAMBA installation
  • Directory release with SAMBA
  • Printer release with SAMBA
  • User-dependent administration of Home directories under SAMBA
  • LINUX as WINS


Linux II- Installation and operation

  • Linux-Distribution
  • Linux Installation in der PC-Plattform
  • Kernel generation
  • Boot-Manager
  • Linux-systems configuration with YaST2
  • Manual configuration
  • User administration
  • Software Installation, distribution and update
  • Central Data retention
  • Data security
  • Security Aspects


Linux, I- Fundamentals

  • Linux as Desktop operating system
  • Linux Distribution
  • Shells and the command lines interfaces
  • Working with and change different shells
  • Linux Data system construction
  • The most important commands
  • Data system authorizations and their administration
  • User creation
  • Visual Editor
  • Communication with other computers
  • X Windows System (X11)
  • Graphic Interface KDE 3.1


Transmission of electron microscopy - Fundamental aspects and results - Interpretation of the results (CNRS, Vitry sur Seine France)

  • TEM and Characterization of materials
  • Instrument and microscopy principles
  • Electrons-matter interactions
  • Geometric crystallography and Fourier transformation
  • Rapid electrons scattering
  • Electronic diffraction and image contrast
  • High resolution imaging and chemical analysis by EDX
  • Electron Energy Loss Spectroscopy in Transmission electron microscopy


Transmission of electron microscopy - Advanced Training and computer analysis of the results (CNRS, Villeurbanne. France)

  • Diffraction and crystal symmetry
  • Artefacts and Image Processing
  • Crystallography and international tables
  • Emission and detection of X-Rays EDS, WDS
  • Acquisition and identification of spectra
  • Spatial resolution and accuracy
  • Quantification and chemical mapping
  • Contrast in METC and Fresnel contrast
  • Scattering and electronic diffraction


Scanning tunneling Near-Field Optical Microscopy (CNRS, Lille France)

  • STM pointer Operation
  • Current tunnel and effect tunnel
  • STM principles in different constants parameters
  • Instrumentation
  • Control Loop
  • Scanner and vibration isolation
  • Point to surface approach and the STM pointer
  • STM Applications
  • STM pictures and topography / Electronic effects
  • Spectroscopy STM and LDOS
  • Field emission and Nano manipulation

Kompetenzen

Kompetenzen

Top-Skills

MBR Design ESP creation PAS-X Expert MES configuration Go-Live support/Hypercare OQ Tests IQ and CSV MINT

Produkte / Standards / Erfahrungen / Methoden

Profile:

  • Experience in Pharma Industry +6 years


Coaching Experience:

2011 - 2021

Place of work: GER- Karlsruhe
Role: Founder of the Coaches & Counsellor Network: Association des coaches et conseillers

Customer: gladly on request


Tasks:

  • with the following main projects to date 
  • Group coaching and conferences in Germany & Africa (Togo, Ivory Coast) 
  • Creation of online products (e.g. Empreintes du Succès (www.empreintesdusucces.com) 
  • One2one coaching 

Vertrauen Sie auf Randstad

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Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

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