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Meet the wega Team

We are a team of highly qualified employees. We are committed to our tasks and specialties with know-how and passion. We offer our qualitative services in English, German as well as in French. Get to know us and get an idea of your wega contact person.

Evelyne
Managing Director
Senior Consultant
CSV Specialist

Project Manager

25 years experience in pharmaceutical industry

Application Management & Business Analysis (LIMS, CDS, Lab Automation & Interfacing of Lab Equipment)

CSV (Validation strategy & documents, Build up of SOP & templates, Risk assessments, Audits, Trainings, agile Validation)

IT Project Management (Software development, implementation, upgrade)

Several trainings, workshops and conference talks about Agility in GxP, 7 years of experience with agile methodologies and agile software projects.

Christian
Managing Director
Finance / HR / Admin

Daniel
Managing Director
Board of Directors
Lab & Research Informatics

Senior Project Manager & Business Analyst

M.Sc. Chemistry (Dipl. Chem., ETH Zurich)

Certified Prof. Requirements Engineering

Experienced in managing interdisciplinary teams of scientists and engineers in complex technical projects

Designing and developing laboratory automation hardware and workflow management software, both series products and customized solutions as Head of R&D for a laboratory automation company

Experience in integrating LIMS and ELN solutions

Software and hardware analysis, design and development according to GAMP guidelines, electronic data management according to 21 CFR Part 11

Christophe
Managing Director
Board of Directors
CSV & QA

Master level degree in Electrical and Computer Engineering (option: Information Technology and Telecommunication engineering)

IREB Certified Prof. Requirements Engineering

ISTQB Certified Tester

Certified Computer System Validation Representative (Concept Heidelberg)

8 years experiences with IT Projects in regulated industry (Pharma and Air Traffic Management. Requirement Engineering, System Design, Test Management, Test Execution according to V-Model

3 Years experience in SW Programming (C/C++ under Linux environment)

Nicolas
Managing Director
Clinical Development Informatics

Strategic Consultant

Clinical Data Science Strategist

Ph.D. in Applied Mathematics, MBA

>25 years of experience in pharmaceutical research organizations and CROs, with a focus on human resource management for data management, biometrics, statistics, data analysis and clinical operations

Board member of BioValley France

Experience in managing complex global projects: Ability to translate analysis, concepts and ideas into compelling communications

Regulatory environment (ICH-GCP, 21 CFR PART 11, CDISC, CDASH, GCDMP guidelines).

Interested in increasing efficiency and effectiveness in the clinical research industry

André
Board of Directors
Founding member of wega

Uschi
Board of Directors
Founding member of wega

Stefan
Board of Directors
Founding member of wega

Christian
Project Delivery Manager
Marketing
Internal IT Services

Senior Project Manager
& Business Analyst

Ph.D. in Experimental Physics

Project Management Professional (PMP)

Project Manager, Business Analyst, Scrum Master

18 years of professional experience in informatics

13 years of experience in project management

15 years of experience in pharmaceutical industry

6 years of experience in governmental sector

Expert in leading international /cross-cultural / virtual project teams

Moni
Management Assistant

Stephanie
HR Assistant
HR & Administration

Stéphanie
Team Lead Sample Management
Senior Business Analyst

Compound Management, Sample Logistics

Master in Computer Science for Business Management

Certified SAQ-Requirements Engineering (Advanced Level)

Certified Scrum Master

Business expertise in pharmaceutical & CropScience industries.

>20 years experience in Lab Automation & Compound Management.

>20 years experience in Software & Hardware Requirements analysis

>20 years experience in compound management software roll out over different sites

>20 years experience in Hardware/Software integration

Karin
Quality Manager
Senior CSV Consultant
Project Manager

Bachelor’s degree in computer management

Bachelors (B.A.) Business Administration

Lead Auditor GxP

Project Manager, CSV and Requirement Engineer

IREB Certified Prof. Requirements Engineering

Quality Management Representative (QMR-TÜV) ISO 9001

Expert on GMP/GDP-Auditing (Lead Auditor)

NLP Master Coach, NLP Practitioner (DVNLP)

20+ years of experience in the field of business administration / IT-environment

15+ years of experience in IT-project management and requirements engineering

15+ years of experience in IT-Sales, IT-process management and software training

6+ years of experience in GxP regulated environment

Hansjörg
CSV & Medical Device Consultant

Business Analyst

Oracle Specialist

Software Engineer

Graduate Engineer (Dipl. Inf. FH)

Certified Prof. Requirements Engineering

Oracle APEX Developer Certified Expert

Oracle Database 11g Administrator Certified Prof.

MS Certified IT Prof. Database Administrator 2008

Analysis, software design, implementation:

5 years experience in PowerCenter Development and Administration (Informatica)

15 years experience in Oracle and DBA

15 years experience in Oracle Development

20 years professional experience in the field of informatics

Oracle APEX, SQL, PL/SQL, Javascript, jQuery, PowerCenter /ETL, Data Warehouse,
CSV Consultant

Thomas
Software Engineer
.NET Specialist

Graduate Engineer in computer sciences (Dipl. Inf. FH)

Oracle PL/SQL Developer Certified Associate

Certified Prof. Requirements Engineering

Analysis, software design and implementation

Extensive business expertise in logistics and pharmaceutical industries:

4 years experience with .NET (C#)

20 years experience in the field of informatics

VBA (Excel, Word, Access, Office Automation), C, C++, Transact-SQL, Oracle, Windows Server NT, 2000, 2003, Uniface, Sybase, Unix, Shell-Skripts, HTML/CSS, ColdFusion, Delphi, SAP/R3 (SD)

Developer of the UniSana-Tool

Mario
Software Engineer
JEE Specialist, Oracle Specialist

Master level degree in Hydrology (Dipl. Hydrologe)

Sun Certified Java Programmer

Oracle Certified Professional

Oracle Internet Application Developer

Oracle Forms Developer Release 6/6i

Certified Prof. Requirements Engineering

5 years of experience with Oracle and PL/SQL

7 years of experience with Java

10 years of experience with software development

Oracle Apex, .Net, Java, Javascript, C++, Python

Sarah
Consultant
Business Analyst

Bachelor of Science in Life Science Informatics

Bachelor of Science in Molecular Life Sciences

IREB Certified Prof. Requirements Engineering

ITIL V3 certified (Foundation Level)

3 years experience with laboratory work in the field of molecular biology

1 year experience with Software Development

Java (Eclipse), Mobile Development (Android), C# (Visual Studio), VBA (Excel & Access), Python

Céline
Consultant
Project Manager
Business Analyst

Bachelor in Information and Library Studies

Project Manager, CSV and Business Analysis

Certified Prof. for Requirements Engineering (Foundation Level)

Professional Scrum
Master I

Change Management Registered Practitioner

NLP Master Practitioner

ITIL Foundation Certification

GAMP5 for Operation of GxP Systems

Certified Associate in Project Management (CAPM)

7 years Project Management

8 years Clinical Development Expert

10 years CSV experience

Claudia
Senior Business Analyst

Senior Business Analyst (CBAP)

Graduate Engineer in Chemistry (Dipl. Chem. HTL) and Informatics (FH/NDS)

CAS in Business Process Engineering

IIBA CBAP Certified Business Analysis Professional

SAQ Certified Software Tester

IREB Certified Prof. Requirements Engineering

Professional Scrum Product Owner I

Professional Scrum Master I

+ 20 years of experience with business analysis, including stakeholder management, business analysis planning, requirement gathering and documentation, process analysis and improvements.

+ 10 years of experience with agile methodologies and agile software projects.

7 years experience with software development and testing in the field Life Sciences, medical engineering, and machine industry.

6 years experience with chemical analytics and structure elucidation in crop sciences and natural compound chemistry.

Daniel
Senior Consultant
Project Manager, Business Analyst

Ph.D in Chemistry

Project Manager, Business Analyst

15 years of experience in Pharma R&D IT

Experience in strategy definition and project portfolio management for Pharma R&D IT and Knowledge Management

Experience in designing and implementing integrated information systems for Pharma Research from laboratory process support to decision-making tools for drug development projects

Experience in leading international R&D IT groups and project teams

Experience in leading and implementing harmonization and integration projects following merge and acquisitions

Experience in small and large project management and realization from business analysis to test and rollout, including programming for integration and customization

Experience in data analysis and data/text mining

Thomas
Senior Consultant
Business Analyst

FH Degree in Informatics

FH (HTL) Degree in Chemistry

Certified Professional SCRUM Master

Certified Professional SCRUM Product Owner

IREB Certified Professional for Requirements Engineering Foundation Level

ITIL Foundation certificate in IT Service Management

Sun Certified Java Programmer

13 years of experience in full stack software development

7 years of experience as business analyst

9 years experience in lab automation

7 years of experience in analytical chemistry of polymers

3 years of experience in chemical synthesis

- Java, C++, VBA, SQL (MS-SQL, MySQL, Oracle), HTML/CSS, Web Development, Project Management, COM/ATL, XML, XSLT

Sabrina
Consultant
Business Analyst

PhD in Biology (Molecular Biology, Biochemistry)

Certified Prof. Requirements Engineering

13 years experience in project and process management

11 years experience in biological safety

6 years experience in biological research

5 years experience in lab safety management

3 years experience in compound management-, biobanking- and sample logistic informatics

Business analysis, testing, support, requirements engineering, student in business informatics

Joachim
Senior Consultant, LIMS,
ELN, paperless lab Subject Matter Expert

Chemical Lab Technician

10 years of experience in project management and account management (LIMS, ELN and paperless lab systems)

10 years of experience as head support organisation (first and second level support of LIMS, ELN and paperless lab systems

10 years of experience in Sales / Pre Sales

10 years of experience in software training (key and end user)

GAMP 5, GxP, process analysis, paperless lab

Thermo Fisher Scientific Sample Manager, Nautilus, Darwin and Chromeleon; LabVantage SQL*LIMS; Accelrys / Biovia ELN, LES and LIMS, Lonza MODA

Mathias
Scrum Master
Scrum Trainer
Agility Coach

Agility coach for validated GxP environments

Graduate Engineer in Biotechnology (Dipl. Ing. FH) and Informatics (FH/NDS)

Certified Scrum Master

Certified Prof. for Requirements Engineering (Foundation Level)

Several trainings and workshops and conference talks (Scrum, Agility in GxP, Scrum Master, Product Owner, SAFe)

10 years of experience with agile methodologies

5 years of experience in Business Analysis &Requirements Engineering

4 years of hands on Laboratory experience in protein chemistry

8 years of experience with Java and Web Development

Greg
Consultant, Business Analyst, CDS System Administrator

LES Developer

Master degree in Animal Biotechnology

Postgraduation in Computer Network Management and Design

Certified Professional Scrum Master

11 years of experience in highly regulated environments

2 years of small molecules analysis in analytical development department

3 years of CDS administration experience

6 years LES development and business analysis

Empower CDS, NuGenesis LES, Oracle SQL

Jürgen
Software Engineer
.NET, JEE Specialist

Master level degree in computer sciences (Dipl. Informatiker)

Sun Certified Java Programmer

IBM Certified Solution Developer

(OO Analysis & Design with UML)

Certified Prof. Requirements Engineering

Oracle specialist

OO, analyse, software design, implementation

10 years experience with .NET

5 years experience with Java

20 years experience with Oracle

5 years experience with Mobile Development

Eclipse, Oracle Designer / Developer, Enterprise JavaBeans, BEA WebLogic, Visual Studio, Android

Guillaume
Consultant
Business Analyst
Project Manager

Nora
Intern

Reinhard
Consultant
Computerized System Validation Specialist

Yannick
Consultant
Research IT Specialist

Master Level Degree in Biochemistry

17 years of experience in life science laboratories (protein biochemistry, molecular biology, in vitro ADME)

14 years of experience in a drug research environment

Assay development and automation on robotic liquid-handling platforms

Automation and streamline of lab data processings (management of samples and requests, compounds logistics)

13 years of user experience with LC-MS/MS

Multivariate statistical data analysis and modelling

Python, R, VBA, HTML/CSS, C/C++

Markus
Consultant
Business Analyst

Piotr
Senior IT Consultant
Project Manager

Master’s degree in electrical engineering

Postgraduate degree in industrial engineering

Postgraduate degree in software engineering

GxP, Data Integrity, GAMP, 21 CFR Part 11, EU Annex 11 PMP Certification

20 years’ experience in pharma industry

13 years’ experience as project manager in industrial engineering implementations

6 years’ experience as project manager in software/application implementation in pharma industry

Pharma laboratory automation & digitalization Computer System Validation

Execution and Maintaining LIMS consultant

Monika
Senior Finance Assistant
Finance / Administration

Andreas
Senior Consultant
CSV Specialist
CSV & GMP Auditor

Ph. D. in Organic Chemistry

Validierungsbeauftragter für Computervalidierung – Pharma IT Expert CSV/GMP Auditor

25+ years experience in pharmaceutical industry (CSV, GMP, Quality Assurance)

Computer System Validation of LIMS, Lab automation, QA and QC systems, MES, supply chain systems, document management systems, master data management systems, risk management systems, training management systems

Rashika
Recruiting Manager
HR Business Partner

Fabian
CSV Consultant
Biochemist

Utz-Peter
Consultant
Business Analyst
Compound Management

Master level degree in Chemical Engineering (Dipl.-Ing. Chemical Engineering)

IREB Certified Prof. for Requirements Engineering (Foundation Level)

Professional Scrum Master I

20+ years professional experience in pharmaceutical industry

18 years head of laboratory for automated parallel synthesis

16 years experience in ELNs, chemical registration and sample management systems

15+ years experience in project management

In-depth knowledge in developing automation concepts, gathering requirements, designing and optimising workflows

Software development of tailor-made R&D applications and interfaces

In-depth understanding of data migration, validating and applying ETL processes

.NET (C#/C++, WPF, Windows Forms, TFS/Git), Java (NetBeans), MS SQL Server, Oracle (PL/SQL/APEX), Pipeline Pilot, JavaScript, Python, PowerShell

Jürgen
Senior Consultant
Business Analyst

Dominique
Senior Consultant
Project Manager
Business Analyst

Engineer degree in computer science

19 years of experience with life science information systems. For academic, R&D, CRO/CMO, QC customers. In pharma, biotech, food, diagnostic, analytical industry

17 years of experience in ELN

10 years of experience as solution architect. Gather & understand workflow, dataflow and technical requirements. Design and implement solutions

15 years of experience in project management & technical project management

15 years of experience in preparing and delivering trainings

Large experience in working in international projects with multicultural and interdisciplinary teams

Experience in working in validated environments (21 CFR Part 11, GxP)

Strong developer background (Java, Oracle, Javascript)

James
Professional Consultant Clinical Development IT

Henning
Senior Consultant Computerized Systems Validation

Diploma in Biology

IREB Certified Prof. Requirements Engineering

ISTQB Certified Software Tester

ITIL Certified

20 years of experience with Software Development, Project Leading and Software Quality Management

15 years of experience with Validation of Computer Systems (Pharmacovigilance, Document Management, Label Control, LIMS, Particle Monitoring, ...) and Qualification of Equipment in pharmaceutical industry (GLP, GCP, GMP and GVP)

Validation Lead, Periodic Review Reports, Audit and CAPA support

Joachim
Senior Consultant
Authorized Officer
Project Manager

Business Analyst

University Diploma in Geology/Paleontology

Certification as Professional Scrum Master (scrum.org) and Professional Product Owner (scrum.org)

More than 16 years leadership experience as IT manager / Head of IT in life-science organisations

More than 20 years experience in project management within IT and environmental geology

Experience in strategy definition, project portfolio in IT

Experience in harmonisation and integration projects in laboratories

Experience in LIMS evalutation and implementation

Experience in Software-Training

Anita
CSV Consultant

Bachelor level degree in Information Technology

Master level degree in Software Engineering and Telecommunications

Master level degree in Business Management (Human Resource)

13+ years’ experience with IT Projects for Pharma, Telecom, Healthcare and Gaming domains performing Quality Assurance, Compliance, Process Management, Computer System Validation (CSV) and Test Management activities.

Julian
Consultant

Caro
Consultant
CSV Specialist
Project Manager

Ph.D. in Translational Biomedicine

M.Sc. Biotechnology

Certified Project Manager

6+ years lab experience in clinical pharmacology/molecular biology

4+ years experience in pharmaceutical and life science industry (CSV and data migration, test management, training, project and portfolio management)

Computer System Validation of eDMS, RIMS, Safety/Pharmacovigilance System, MES, Label Management

Miro
Intern

Anna
Intern

Louise
Marketing and Digital
Communication Specialist

Master in E-Marketing and Digital Strategy

Bachelor in International Business

> 3 years' experience in digital communications and marketing

> 3 years' experience in event project management

> 2 years' experience in website design and management

Web design, Operational marketing, Brand management, Digital marketing, Events, Digital strategy, Community management, Visual design, E-mailing campaign management

Jakub
CSV and Quality Management Consultant

Master Degree in Biotechnology

Postgraduate Studies in Managing the Clinical Trials

IREB Certified Prof. Requirements Engineering

11 years of experience in GxP regulated environment (mostly Pharma Industry)

8 years of experience in Computerized System Validation Specialist

2 years of experience in Quality Control and Assurance Department

1 year of experience in Cell Therapy Laboratory

HP ALM trainer, Cloud Based Solution Validation (e.g. Veeva Vault QMS), Good Documentation and Testing Trainer, Agile Project Management Methodology Experienced

Piotr
CSV Consultant
Laboratory System Administrator

- Master degree in Chemical Technology

- Postgraduate degree in Computer Network Management and Design

- 9 years of experience in regulated pharmaceutical industry

- 7 years of CDS, LabX and other laboratory systems administration

- 4 years of analytical equipment qualification supervision

- 2 years of small molecules analysis in analytical development department

- Empower, LabX, analytical equipment qualification

Severine
HR Specialist

Lukas
Senior Consultant
Chemical Lab Technician

Enterprise Chromatography Data System (CDS) Subject Matter Expert

15 years experience in installation, configuration and qualification of enterprise CDS

15 years experience in delivering 1st, 2nd and 3rd level support for enterprise CDS customers

10 years of experience as consultant in the conception and architecture of enterprise CDS

10 years experience in developing and executing trainings for CDS users, key Users and administrators

8 years experience in installing, maintain, repair and qualify HPLC, IC and MS Systems

GxP, Data Integrity, 21 CFRP Part 11

Thermo Fisher Scientific Chromeleon 6

Thermo Fisher Scientific Chromeleon 7

HPLC, GC, IC, MS

Michael
Life Science Consultant

Christian
Consultant
Laboratory Technician

Anna
Life Science Consultant

Sebastian
Consultant
Project Manager
Business Analyst

Birsen
CSV & Medical Device Consultant

Adrien
LIMS Consultant

Trinational bachelor's degree in information technology (France, Germany, Switzerland)

>3 years experience in the pharmaceutical industry
>2 years experience in LIMS
>2 years experience in CSV
1 year project management experience

Basic CSV training
Certified ISTQB Software Tester (Foundation Level)
Certified Scrum Master Professional 1
Certified CSV (Concept Heidelberg )

Project Management, Business Analysis, Databases, Testing, Networks, IT Systems, Programming

Erika
Consultant

Microsoft Certified Professional

Microsoft 365 Certified: Teams Administrator Associate

ITIL Foundation Certificate

More than 20 years professional experience in the field of informatics in several roles:
- Technical Lead
- Project Management
- System Administrator
- End-User Support

10 years’ Experience in Pharma / Healthcare industry

Jira / Confluence Specialist

Experience in CSV

CSV Training

GCP Basic Course

Teyfik
Life Science Consultant

Tilman
Senior Consultant

Pascal
Senior Consultant
Full Stack Software Engineer
System Engineer

Bachelor of Engineering in Informatics

Microsoft Certified Professional Azure

Professional Scrum Master I

ITIL Foundation Certificate

Exasol Certified Administrator & Developer

8 years of experience with Software Development

8 years of experience in System Engineering Experience in various lab digitalization projects

C# .NET, Java, SiLA, Groovy, HTML, CSS, Mobile Development, Oracle, MSSQL, Exasol, Microsoft 365, Microsoft Azure, Project Management, System/Software Architecture, Scrum, ETL, DWH

Franziska
Senior OCM Consultant
Project Manager

Gabriele
Life Science Consultant
Business Analyst
Project Manager

FH Degree in Informatics

IREB Requirements Engineering Foundations

Certification as Professional Scrum Master (scrum.org) and Professional Product Owner (scrum.org)

30 years of experience in pharmaceutical industry and regulatory agencies

15 years head of application management and support management teams

Delivery Management

Worked in several business-critical projects as project manager

Denise
Consultant
Business Analyst

Master of Science in Computer Science (Minor in Biology)

Bachelor of Science in Bioinformatics

SAQ Certified Professional for Usability and User Experience – Foundation Level

4 years of experience in software engineering (software development, testing, deployment and monitoring)

1.5 years of experience in working with transcriptomics data (RNA-Seq, preprocessing and QC, read mapping, quantification and differential analysis, data visualization)

Cross-functional communication with business and technical stakeholders

Java, Swift, R, R Shiny, SQL, XML, Spring Boot, Docker, Jira, Confluence, Scrum

Karim
Senior Consultant
Solution Architect

Master degree in Computer Sciences / Software Engineering

>25 years of delivering software architecture, software engineering (java, c++, agile) in the Life Science, legal and financial sectors

Design and implementation of software solutions for early (pre-clinical) drug discovery, including in validated environments

Experienced in managing teams of business analysts, software engineers, scientists and external suppliers

Experienced in building software solutions for Compound Management teams

Solution oriented and making people work together

Robin
Consultant

Chromatography Data System (CDS) Subject Matter Expert

9+ years of experience in Laboratory Equipment supported analysis service and maintenance. (GC, MS, HPLC)

13+ years of experience in Laboratory Analysis

7+ years of experience in method development

6+ years in Reporting and automatization in chromatography environments

6+ years in experience in training basic, advanced, and professional staff in CDS Software and theory in applied usage of mass spectrometry

6+ years experience in delivering 1st, 2nd and 3rd level support for CDS customers

Thermo Fisher Scientific Chromeleon 6

Thermo Fisher Scientific Chromeleon 7

Thermo Fisher Scientific Xcalibur – Tracefinder

HPLC, GC, MS, MSMS, High resolution Mass spectroscopy

Niklas
Consultant
Software and Data Engineer

Master of Science in Computer Science (Minor in Data Science)

Bachelor of Science in Biochemistry (Minor in Bioinformatics)

ISTQB Certified Tester (Foundation Level)

IREB Certified Professional for Requirements Engineering (Foundation Level)

Certified Professional Scrum Master I

3 years of experience in software engineering

Python, Java, C#, SQL, Linux, Bash, HTML, Javascript/Typescript, CSS

SiLA 2 Expert

Virginie
Consultant for Life Sciences
and Drug Discovery

MSc HES-SO in Chemical Process and Development

8 years of experience in the pharmaceutical industry

5 years of experience in process development and optimization of small molecules

1+ year of experience in Hit to Lead chemistry for the discovery of small molecules

1+ year of experience in GMP environment (QC & IPC)

3+ years as training supervisor for chemistry lab technician apprentices Experience in:

• Project management, business analysis

• Test automation

• Laboratory automation

• Database

• Lab equipment commissioning, risk analysis & maintenance (especially flash chromatography systems & LC-MS)

• Organic chemistry & drug discovery (HTL, route-scouting, optimization & scale-up)

LabVIEW, Matlab, MS 365, Access DB, VBA, SQL, HTML, Chromeleon, Empower, MassLynx, Ranorex, Pipeline Pilot

Kathrin
Consultant

Ouisseme
Life Science Consultant
Data Scientist
Business Analyst

Julia
Consultant

Salah
Consultant

Firat
Consultant

Monika
CSV & QA Consultant

Adrian
CSV Consultant

Robert
Junior CSV Consultant

Dagmara
OCM Consultant
CSV Consultant
Project Manager

Jörg
Senior Consultant

SME ELN, paperless lab, lab automation

Business Analyst

Requirements Engineer
Project Manager

Dr. in Organic Chemistry
Diploma in Organic Chemistry

IREB Certificed Requirements Engineer

20+ years of experience in the pharmaceutical industry

10+ Years in ELN, LIMS and Laboratory Automation

10+ Years in R&D IT and R&D IT Operational Support

10+ years of experience in computer systems implementation and validation in a regulated environment

10+ years of leadership experience of global and cross-functional teams

Mario
Data Scientist
Life Science IT Consultant
GxP Pharma QC Specialist

Meike
Life Sciences Consultant
Health Care Manager

MSc FHNW in Life Sciences with major in Molecular Technologies

BSc FHNW in Life Sciences with major in Molecular Bioanalytic

Biological-technical Assistant in Molecular Biology

Experience in molecular pathology diagnostics, cytotoxicity testing of medical devices, noble metal analytics, laboratory and interdisciplinary management of molecular pathological processes patient-related data or patient samples

CSV Basic Training

Computer System Validation (CSV)

Quality Management

Laboratory and interdisciplinary management

DIN EN ISO 9001

DIN EN ISO 10993

Common analytical methods in the fields of Life Sciences

Xi
Life Science Consultant

Michael
Senior Consultant
Senior Business Analyst

Diploma in Biochemistry/Molecular Biology

Ph.D. in Biophysics/Structural Biology

Professional Scrum Product Owner

Professional Scrum Master

10 years of experience in the pharmaceutical & life science industry

CSV and Quality Assurance

GMP Adverse Event Management

Document Management Systems

Laboratory Information Management Systems

Agile Software Development

Backlog Management

Business Analysis

Requirements Management

Jonas
Consultant
Business Analyst

Ana-Cristina
CSV Consultant

Daniel
Life Science Consultant

Telecommunications Engineer (BSc & MSc)

Postgraduate Certificate in Education (MSc)

>10 years of experience in technical projects across IT, pharma, education and banking industries

>3 years of IT experience within regulated GMP pharma environment:

EU GMP Annex 11 / FDA 21 CFR Part 11
Computer System Validation according to ISPE GAMP5 guidelines
Electronic Data Management and Integrity

Specialized in management information systems, business analysis, system administration and IT support

Richie
Medical Device Consultant

Elke
Senior Consultant

Nina
Life Science Consultant
Business Analyst

Virginia
Technical Sales
(ARGUS Products)

Nils
Junior Consultant

Marc
CSV & Medical Device Consultant

Romain
Junior CSV Consultant

Bachelor's degree in automation and industrial informatics

CSV Basic Training

IREB Foundation Level

1 year of experience as automation technician in the precast concrete elements industry

3.5 years experience as part of the team responsible for the implementation of a SAP S/4 Hana project

Project manager and business analyst for industry oriented softwares interfaced with SAP

Knowledge in project management, SAP, business analysis, programming, IT systems, software testing, key users and end users training

Dominic
Life Science Consultant

Steven
Senior Consultant
Senior Business Analyst

PhD in Chemistry, specialized in molecular modeling and chemoinformatics

>20 years experience in Pharma R&D

Founder of a screening CRO and 10 years management experience as CTO

>20 years experience in business analysis and project management

>20 years experience in lab automation and high throughput screening

>20 years experience in data management, pipelining and analysis

>20 years experience in chemoinformatics and software tools

>10 years experience in international government-funded collaborations

>10 years experience in business development

Dominique
Life Science Consultant
Lab Automation Consultant

Celine
Life Science Consultant
Business Analyst

MSc in Pharmacology and Toxicology In Vivo with 13+ years in pharmaceutical industry in In vivo, drug safety and toxicology as research associate

Certification for SEND implementation CDISC

Experienced Business Analyst with focus of interdisciplinary teams of scientists and engineers in complex technical projects

Designing lab workflows and optimizing IT solutions

Project management

Data FAIRification

Power BI

Annika
Life Science IT Consultant
Business Analyst

PhD in Biochemical Pharmacology / Applied Bioinformatics

MSc & BSc in Life Science

CSV Basic Training

Basic Certificate in Project Management (GPM)

>6 years experience implementing laboratory software projects, mastering roles in business, IT and on vendor side.

>4 years of research experience in systems biology.

Expert in LIMS projects, excelling in business analysis, requirements elicitation, engineering, interface development, project coordination and stakeholder engagement.

Leading roles in several projects with successfully orchestrated implementations, system releases and system selections in (bio-)pharmaceutical, research, and diagnostic laboratories.

Reliable and dedicated professional with strong organizational skills, a solution-oriented mindset, and quick adaptability.

Rajiv
Senior Consultant
Project Manager

B.Sc. in Chemistry

Ph.D. Candidate in Biochemistry

Certified SAFe Scrum Master

>10 years of diverse research experience in clinical and pre-clinical trials, high-performance computation, and R&D laboratory proficiency

>12 years expertise in Project Management and Business Analysis

Specialization in Molecular Biology, Instrumentation, Magnetic and Optical Spectroscopy

Experienced in agile software development, DevOps, CI/CD, Lab IT, Data FAIRification, LIMS selection, design, development, testing, interfacing, and reporting, strategy and delivery of large-scale IT projects in government, life science, and pharmaceutical sectors, OCM, GxP, Data Integrity, and 21 CFR Part 11

Ralf
Senior Consultant
Solution Architect

Master level degree in Computer Sciences / Software Engineering

Certified Requirements Engineering

Certified AWS Solution Architect & Developer

Certified Java Programmer

Experienced in managing interdisciplinary teams of scientists, engineers, and external suppliers in complex global technical projects

Design and implementation of laboratory automation hardware and workflow management software as engineering team lead at Novartis (NIBR)

Design and implementation of Data Architecture solutions for drug discovery research applications

> 25 years experience in project delivery, business requirements, software architecture and (agile) software engineering (java, node.js, python)

> 14 years experience in life science research

> 7 years experience in government sector

> 4 years experience in financial sector

Daniela
Finance Assistant
Finance & Administration

Sebastian
Consultant
Business Analyst
Project Manager

Bachelor of Arts Business Informatics

Certification as Professional Scrum Master

CAS in Project Management

10+ years of experience with business analysis, including stakeholder management, business analysis planning, requirement gathering and documentation, process analysis and improvements

7+ years experience in the regulated and non-regulated area for harmonization, connectivity and governance projects for R&D laboratory instruments

Software installation, configuration, validation, administration, maintenance Business analysis, CSV, GAMP 5, lab automation

GxP, Data Integrity, 21 CFRP Part 11