Oliver Wulf-Specialist Planner / Cleanroom Planning Lead

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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
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Healthcare, Manufacturing, Aerospace and Defense, and Pharmaceutical.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Project Management, Production, Operations, and Supply Chain Management.
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
Industriemeister for chemistry and process engineering · Waldshut-Tiengen, Germany
Hoffmann La Roche AG
Apprenticeship to chemical technician · Grenzach-Wyhlen, Germany
Certifications & licenses
ISO 13485:2016 Lead Auditor
BSI
Secora AG
Six Sigma Green Belt
Secora AG
ISO 90XX / 13485 Lead Auditor
Moodys International
Statistics
Experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Oliver is based in Hildisrieden, Switzerland and can operate in on-site, hybrid, and remote work models.
Oliver speaks the following languages: German (Native), English (Advanced), French (Intermediate).
Oliver has at least 20 years of experience. During this time, Oliver has worked in at least 6 different roles and for 7 different companies. The average length of individual experience is 2 years. Note that Oliver may not have shared all experience and actually has more experience.
Based on recent experience, Oliver would be well-suited for roles such as: Specialist Planner / Cleanroom Planning Lead, Project Lead, Head of Quality.
Oliver's most recent position is Specialist Planner / Cleanroom Planning Lead at Major Aircraft Manufacturer.
In recent years, Oliver has worked for Major Aircraft Manufacturer, Major MedDev Company, and Hospital in eastern Switzerland.
Oliver is most experienced in industries like Healthcare, Manufacturing, and Aerospace and Defense. Oliver also has some experience in Pharmaceutical.
Oliver is most experienced in business areas like Quality Assurance, Project Management, and Production. Oliver also has some experience in Operations and Supply Chain Management.
Oliver has recently worked in industries like Healthcare, Manufacturing, and Aerospace and Defense.
Oliver has recently worked in business areas like Quality Assurance, Project Management, and Operations.
Oliver holds a Bachelor in Industriemeister for chemistry and process engineering from IHK Hochrhein-Bodensee.
Oliver has 5 certificates. Among them, these include: ISO 13485:2016 Lead Auditor, Six Sigma Black Belt, and Six Sigma Green Belt.
The availability of Oliver needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 7 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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