Pharma , Food , and MedTech Consultant / Project Manager / ad -Interim for Quality Assurance, Engineering, Production, Labor...

In the last 13 years, I worked in the pharmaceutical, food, and medical devices industries as a project or portfolio manager and head of departments. Successfully led CapEx and OpEx projects, such as international greenfield and brownfield projects.

• CapEx/OpEx
• DIN EN ISO 13485
• Good Manufacturing Practices5 J.
• operational excellence
• Projektmanagement
• Qualitätsmanagement / QS / QA (IT)1 J.
• Research and development
• System Integration
• Team Building4 J.
• Workflows1 J.

With over a decade of experience in the Pharmaceutical Industry, I bring energy,
ambition, and agility to every project. Notably, I spearheaded the successful
delivery of the Serialization Project and supervised the reconstruction of the
Nestlé Packaging Area, demonstrating my hands-on approach and ability to
meet deadlines and budgets. My fluency in GMP, coupled with economic and
technical expertise, enables me to thrive in team environments, finding
pragmatic solutions to production challenges. As Head of Engineering, I
reorganized the department, ensuring compliance with ISO, GxP, and company
guidelines, while leading successful factory expansion projects. Recently, I
transitioned to the role of an international program manager,
overseeing multimillion-Euro CapEx programs across diverse teams and
nations in the pharmaceutical, medical devices, and in vitro diagnostic industry.

People management:
Head of Engineering:
Led a team of up to 24 engineers across 2 shifts, managing R&D, Maintenance & Improvement, HSE (Health, Safety, and Environment), and Project Management.

Project Leadership:
Demonstrated strong lateral leadership skills by managing and collaborating with cross-functional teams of up to 200 people from 15 different nationalities on complex projects.

Project / Portfolio management:
- Experienced expert in the areas of construction and expansion of production facilities and lines (Program Manager of the inaugural aseptic fill & finish production site in Morocco)

- Successful project/program management for international brown and green field CapEx projects up to 500 millions euros (8 buildings, 3 sterile fill and finsh lines with clean and black utilities, production buildings, compounding, filling, visual inspection, packaging, Track&Trace, SCADA, MES, ERP and laboratory incl. LIMS) as well as qualification and validation at renowned Pharma-MAHs, CMO and CDMOs while meeting time, scope and budget constraints.

- Specialized in Implementation, qualification and validation of software solutions (SaaS, On-Premise, IaaS) such as T&T, Veeva eQMS, LIMS, ERP (Modules), MES, SCADA & DI/DO with a focus on paperless production and data analysis.

- Comprehensive expertise in cleanroom construction according to Annex 1 and in the commissioning of filling lines (vials and syringes) for renowned CDMOs.

- Successfully led projects in clean and black utilities, production buildings, compounding, filling, visual inspection, packaging, Track&Trace, SCADA, MES, ERP and laboratory incl. LIMS.

- Proactive in OEE optimization on machines and processes (Overall Equipment Efficiency) as well as in machine retrofits. Expertise in implementing production data acquisition (PDA /BDE) systems to increase transparency and efficiency, including employee training.

- Known in transitioning cash management for CDMOs.

- Project leader for global implementation of Data Integrity and GAMP 5 version 1
and 2.

- Changing of processes regarding to LEAN and 6σ (six Sigma) in the packaging area, to increase the OEE (after implementation of PDA-System) up to 15%.

- Developed and implemented a Supply Chain Management (SCM) structure for a startup medical device company, ensuring efficient material flow, streamlined logistics, and cost-effective operations.

QA:
- Conducted remediations for regulatory audits with CAPA and Change Control (CC) implementation, focusing on quality and efficiency.

- Implementation of the new qualification strategy for medical devices production, to be complied with the ISO 13485, 14971 and 60601.

- Implementation of the data integrity strategy and software risk evaluation for two clients

- creating the strategy how to implement under GxP a global LIMS on a local site

- leading remediation projects including (DI, cross contamination and HAVC)

Qualification and Validation:
- Clean room qualification (ISO 14644, 14698, 14645, 14641, 5832 and GMP-Annex1)
- Process qualification
- cleaning validation
- Software validation (T&T, SAP, LIMS, EMRS, SCADA, MES and there interfaces)
- Utility's for clean and black areas (Compressed air supply, Cooling water supply, Steam supply, Vacuum pumps)
- Creating all documents regarding GDoc.P and training of the employees

R&D:
- Experience in research and development of process, equipment and software.

HSE:
- Machine update: Verify compliance with the EU Machinery Directive 2006/42/EG.

- New Machinery Regulation (MRL) implementation strategy: Develop a plan to be compliant with the MRL by January 20, 2027, with a focus on cybersecurity.

- Implementation of LOTO (Lock out Take out)

- Supplier training on safety regulation before entering the site

- Training to become a safety coach

- Risk evaluation for all technical operation on a pharmaceutics Production site including ATEX.