Oliver Wulf
Specialist Planner / Cleanroom Planning Lead
Experience
Specialist Planner / Cleanroom Planning Lead
Major Aircraft Manufacturer
- Start-up and commissioning of the cleanroom
- Certification of the cleanroom
Project Lead
Major MedDev Company
- Start-up and commissioning of production equipment, e.g. clean rooms and production equipment
- Commissioning support for a newly built manufacturing plant for BG/E Sensors
Project Lead
Hospital in eastern Switzerland
- Technical planning of building integration and process engineering including basic and detail engineering
- Start-up, commissioning and qualification of production equipment, e.g. clean rooms and general production equipment
- Validation of manufacturing processes, test methods and cleaning processes
- Responsibility for the achievement of the production authorization granted by swissmedic
Project Lead
Major MedDev Company
- Technical planning of building integration and process engineering including basic and detail engineering
- Start-up, commissioning and qualification of production equipment, e.g. clean rooms and general production equipment
- Validation of manufacturing processes, test methods and cleaning processes
- Compliance with Chinese standard YY0033, 21 CFR 820 and ISO 13485:2016
Project Lead
Hospital in central Switzerland
- Technical planning of building integration and process engineering including basic and detail engineering
- Start-up, commissioning and qualification of production equipment, e.g. clean rooms, production roboteer and general production equipment
- Validation of manufacturing processes, test methods and cleaning processes
- Responsibility for the achievement of the production authorization granted by swissmedic
Head of Quality
International Medical Device Manufacturer (affiliate site in Germany)
- Performed the role as QMB for the site
- Led the QA team at the site
- Improved quality related procedures such as internal auditing, supplier management, CAPA and document management
Project Lead, Process Designer
International Medical Device Manufacturer
- Integration of two satellite sites in Germany and Spain into the Quality Management System of the certificate holder in Switzerland
- Harmonization of global quality processes across three sites
- Process training and support
- Hosted the certification audit for the Matrix Certificate as company representative
Project Lead
International Medical Device Manufacturer
- Project management including timeline, budget, staffing and reporting
- Technical planning of building integration and process engineering including basic and detail engineering
- Start-up, commissioning and qualification of production equipment, e.g. clean rooms, filling lines, multipurpose mixing tanks and process control systems
- Validation of manufacturing processes and cleaning processes
Project Lead, Head of Validation
International Medical Device Manufacturer
- Technical planning of building integration and process engineering including basic and detail engineering
- Start-up, commissioning and qualification of production equipment, e.g. clean rooms, filling lines, autoclaves and process control systems
- Validation of manufacturing processes and cleaning processes
Sub-project Leader, Analysis, Implementation, Training
International Pharmaceutical Company
- Analysis of processes, their interfaces and redundancies
- Redesign of the process landscape and processes together with process users (voice of customer)
- Training and support of the new structure
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Healthcare (18 years), Manufacturing (10.5 years), Aerospace and Defense (4 years), and Pharmaceutical (2 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (18 years), Project Management (16 years), Production (14 years), Operations (12 years), and Supply Chain Management (0.5 years).
Skills
Fields Of Experience
25 Years Of Experience In Pharmaceutical Quality Systems According To Pic/s Gmp And 21cfr210/211
25 Years Of Experience In Medical Device Quality Systems According To Iso 13485 And 21cfr 820
15 Years Of Experience In Cleanroom Planning According To Iso 14644 And Vdi 2083
20 Years Of Experience In Auditing Pharmaceutical And Medical Device Quality Systems
15 Years Of Experience In Auditing Quality Systems According To Iso 9001, Iso 13485 And Pic/s Gmp
Core Skills
- Project Management
- Medical Device Industry, All Processes According To Iso 13485 / 21 Cfr 820
- Quality Management Systems According To Iso 9001/13485
- Quality Management Systems According To Pic/s Gmp, 21 Cfr 210/211
- Cleanroom Technologies, Iso 14644 & Vdi 2083
- Auditing / Audit Management / Supplier Quality
- Process Analysis / Process Design
- Risk Management
- Qualification Strategies / Qualification Of Production Equipment
- Chinese Gmp Standards, Especially Yy0033
Internal Functions
- Managing Director
- Head Of Projects & Engineering
Methods And Tools
- Process Analysis And Design: Lean Six Sigma, Business Process Modelling
- Project Management: General Project Management Methods, Microsoft Project, Network Charts, Gantt Charts
- Qualification And Validation: V-modell, Family Approaches In Qualification And Validation, Risk-based Testing, Cots Equipment Qualification, Validation Master Planning
- Compliance Management: Business Process Modelling (Bpm), Qm-system According To Iso 9001, Quality Management Systems According To Iso 9001 And/or Iso 13485
- Auditing & Audit Management: Triple-a-approach, Auditing Following Iso 19011
- Risk Management: Failure Mode And Effect Analysis (Fmea), Risk Management Workshops, Risk Based Approach, Risk Based Testing, Risk Management According To Iso 14971 And/or Iso31000
Industries
- Medical Device Manufacturers, Pharmaceutical Industry
- Hospitals And Related Healthcare Industry
- Suppliers To Medical Device Manufacturers
- Any Industry Using Quality Management Systems
Languages
Education
IHK Hochrhein-Bodensee
Industrial Foreman in Chemistry and Process Engineering · Waldshut-Tiengen, Germany
Hoffmann La Roche AG
Apprenticeship as a Chemical Technician · Grenzach-Wyhlen, Germany
Certifications & licenses
ISO 13485:2016 Lead Auditor
BSI
Six Sigma Black Belt
Secora AG
Six Sigma Green Belt
Secora AG
ISO 90XX / 13485 Lead Auditor
Moodys International
Microsoft Certified Professional / Microsoft Certified Trainer
Profile
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