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Description

Cross-industry leadership experience

Leadership | Project Management

Technical and organizational overall management of complex industrial and IT projects
Automotive, Aerospace, Chemicals, Pharmaceuticals, Food, Semiconductors, Manufacturing
Interim Management and Disciplinary Leadership: Taking immediate leadership responsibility, including disciplinary positions, to bridge vacancies or lead specific business units.
International professional and disciplinary leadership of interdisciplinary project teams
Holistic project responsibility: Leading and managing complex projects (End2End) from initiation to successful completion, including budget and resource responsibility.
Multi-project management with end-to-end responsibility
Structuring the project process into defined phases, milestones, stage-gate model
Initiation, Design, Implementation, Testing, Go-Live, Handover
Definition, monitoring, and evaluation of gate criteria and KPIs to ensure project progress, cost, and schedule adherence
Management of change, risk, and escalation processes in complex project environments
Team Leadership: Professional leadership of interdisciplinary teams, consisting of

* Experts in software & peripheral system implementation, data migration

* SAP IT/OT Consulting

* MES / Batch PCS7 / SCADA Development

* Hardware / Software Development

* Automation

Project Management & Governance

Overall responsibility for scope, budget, schedule, quality, and risks in pharmaceutical IT/OT projects
Establishment and management of project governance structures (Steering Committees, decision-making boards, escalation paths)
Creation and maintenance of:

* Project plans (milestones, dependencies)

* Resource and capacity planning

* Budget and cost overviews

Application of classic / agile and hybrid methods (e.g., V-model, Waterfall, agile elements, depending on validation requirements)

Languages

German
Native or bilingual
English
Fluent
French
Basic

Workplace preferences

Can work on-site

Spenge (up to 50km)

Curevac AG – Pharma & Biopharmazie,
Project Manager – S/4HANA / MES – OpCenter / Batch / IT OT / PLM / PLS / PCS7 / PCS NEO / Automation
PHARMACEUTICALS INDUSTRY
August 2023 - Today (3 years)
72 Tübingen, Germany
Leadership | Project Management
Leading, being responsible for, organizing, and managing the entire area of the Liquid Nanoparticle (LNP) production facility and the system landscape & interfaces - SAP S/4HANA - MES – OpCenter - BATCH CC – PCS7 NEO - Process Control System
Project management with holistic project responsibility for the LNP production plants as well as process, development, electrical, construction, automation, GMP qualification & validation, maintenance, and manufacturing
Leadership and coordination of interdisciplinary teams, R&D, production, quality control, and suppliers
Ensuring compliance with regulatory requirements (e.g., FDA, EMA)
Identifying and assessing risks, as well as developing risk mitigation measures
Adherence to quality standards in all project phases
Effective communication with stakeholders, including internal teams and external partners
Concept | Design Planning | Specification
URS User Requirements Specification
RTM Requirement Traceability Matrix
ERP Enterprise Resource Planning Specification
MES Manufacturing Execution System Specification
SCADA Supervisory Control and Data Acquisition Specification
PID Piping and Instrumentation Diagram
ICL Instrument and Components List
UL Utility List
FDS Functional Design Specification
ESP Engineering Specification
SDS Software Design Specification
HDS Hardware Design Specification
ALD Automation Layout Drawing
WID Wiring Diagram
PAL HW Parameter Lists of Field
ALM Access Level Matrix
ALL Alarm List
PWL Password List
BOR-HMI Boundary Limits Human Machine Interface
DID Data Integrity Diagram
DIR Disaster Recovery
TPM Test Plan Matrix
FATPR FAT Plan / Report
SATPR SAT Plan / Report
IQPR IQ Plan / Report
OQPR OQ Plan / Report
IFO Operating Manual
Project Management Office Process Management ERP System Customization IT Project Management MES
Roche AG – Pharma & Diagnostics,
Project Manager -SAP S/4HANA / MES – OpCenter / Batch / IT OT / PLM / PLS / PCS7 / PCS NEO
PHARMACEUTICALS INDUSTRY
November 2021 - July 2023 (1 year and 8 months)
82377 Penzberg, Germany
Leadership | Project Management
Leading, being responsible for, organizing, and managing the cross-system area of "Recipe" in the ASPIRE & EuMES project and the entire system landscape & interfaces – ERP - SAP S/4HANA INFOR- MES – OpCenter - BATCH CC – PLS Technology
Project management with holistic project responsibility, Project Management Office (PMO) – Stream MFC Recipe
Responsibility for the global DS MES Business Process Harmonization (BPH) for Recipe Design & Verification at the Penzberg site and professional exchange with global representatives of production sites worldwide
Leadership of stakeholders and experts (SME) and coordination of affiliated groups and suppliers (Siemens)
Concept | Design Planning | Specification
Responsibility for the design specifications DS MES OpCenter Design, DS MES OpCenter Function, and DS Batch Recipe
Creation of project, development, test, and quality plans, timelines, mapping of system and test strategies, and the Define and Deploy phases
Planning of innovative design specifications across all project phases for recipe management
Basic Concept | Basic Design | Complete Commissioning | Detail Design
Definition of the development and test phase - methodologies (V-Model)
Analysis, specification of system and software requirements, architecture design, implementation, unit/integration testing, verification, validation
Data Migration | ERP - SAP S/4HANA | INFOR LN Cloud| Development
Analyzing and consulting on business processes for functional mapping in SAP | INFOR
Clarification and moderation of the target architecture MES vs. ERP including integration design
Management of complex MES-ERP integrations (including those with BAAN/LN predecessor systems as a basis)
Interface management with production machines, time tracking, detailed planning, and warehouse logistics
Global roll-outs of systems, process data, templates, logic for mapping, and rules
Project Management Office ERP System Customization ERP Integration with External Systems MES SAP S/4HANA
Roche AG – Pharma & Diagnostics, Prozess Automation Solution
Project Manager - Branch Manager - Multi-Project Management
PHARMACEUTICALS INDUSTRY
January 2021 - October 2021 (9 months)
82377 Penzberg, Germany
Leadership | Project Management
Leading, being responsible for, organizing, and managing projects within the biotech & pharmaceutical industry with a focus on automation, electrical, control, and process control technology for the customer Roche
International experience in professional and disciplinary leadership
Project management with holistic project responsibility, Project Management Office (PMO)
Maintaining and expanding business relationships with customers and suppliers
Preparation of target and performance reviews in coordination with management
Contracts | Investment | Sales
Evaluating and drafting employee contracts, service agreements, individual project contracts, framework agreements,
Works contracts and general terms and conditions
Capacity, cost, capex, and investment planning for projects in the biotech & pharmaceutical industry
Evaluating and drafting employee contracts, service agreements, individual project contracts, framework agreements, works contracts, and general terms and conditions
Capacity, cost, and budget planning, financing agreements, cost controlling, fund disbursement planning, economic feasibility analysis, investor controlling
Business Process Management | Process Management | Integrated Planning
Analyzing, modeling, and documenting existing business processes
Applying standardized Business Process Model and Notation (BPMN) for representing and modeling business processes
Flow Objects: Basic building blocks of BPMN
Connecting Objects: Connecting elements of all building blocks
Artifacts: Understanding / information building blocks
Swimlanes and Pools: Representation of process participants
Structuring and dividing individual process elements and variations of different process flows for process management to model and optimize individual interfaces
Implementing optimized improvement measures and monitoring integrated processes for functionality and desired impact
Project Management Office Process Management MES Batch Multiproject Management