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Oliver Wulf

Specialist Planner / Cleanroom Planning Lead

Oliver Wulf
Hildisrieden, Switzerland

Experience

Jan 2022 - Present
4 years 3 months

Specialist Planner / Cleanroom Planning Lead

Major Aircraft Manufacturer

  • Start-up and commissioning of the cleanroom
  • Certification of the cleanroom
Jan 2020 - Present
6 years 3 months

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
Jan 2020 - Dec 2026
7 years

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
Jan 2019 - Dec 2022
4 years

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
Jan 2017 - Dec 2020
4 years

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
Jan 2017 - Jun 2017
6 months

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
Jan 2014 - Jun 2014
6 months

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
Jan 2011 - Dec 2014
4 years

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
Jan 2007 - Dec 2010
4 years

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
Jan 2005 - Dec 2006
2 years

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).

Healthcare
Manufacturing
Aerospace and Defense
Pharmaceutical

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).

Quality Assurance
Project Management
Production
Operations
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

German
Native
English
Advanced
French
Intermediate

Education

Oct 1995 - Jun 1996

IHK Hochrhein-Bodensee

Industrial Foreman in Chemistry and Process Engineering · Waldshut-Tiengen, Germany

Oct 1993 - Jun 1995

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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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Oliver based?

Oliver is based in Hildisrieden, Switzerland and can operate in on-site, hybrid, and remote work models.

What languages does Oliver speak?

Oliver speaks the following languages: German (Native), English (Advanced), French (Intermediate).

How many years of experience does Oliver have?

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.

What roles would Oliver be best suited for?

Based on recent experience, Oliver would be well-suited for roles such as: Specialist Planner / Cleanroom Planning Lead, Project Lead, Head of Quality.

What is Oliver's latest experience?

Oliver's most recent position is Specialist Planner / Cleanroom Planning Lead at Major Aircraft Manufacturer.

What companies has Oliver worked for in recent years?

In recent years, Oliver has worked for Major Aircraft Manufacturer, Major MedDev Company, and Hospital in eastern Switzerland.

Which industries is Oliver most experienced in?

Oliver is most experienced in industries like Healthcare, Manufacturing, and Aerospace and Defense. Oliver also has some experience in Pharmaceutical.

Which business areas is Oliver most experienced in?

Oliver is most experienced in business areas like Quality Assurance (QA), Project Management, and Production/Manufacturing. Oliver also has some experience in Operations and Supply Chain Management.

Which industries has Oliver worked in recently?

Oliver has recently worked in industries like Healthcare, Manufacturing, and Aerospace and Defense.

Which business areas has Oliver worked in recently?

Oliver has recently worked in business areas like Quality Assurance (QA), Project Management, and Production/Manufacturing.

What is Oliver's education?

Oliver holds a Bachelor in Industrial Foreman in Chemistry and Process Engineering from IHK Hochrhein-Bodensee.

Does Oliver have any certificates?

Oliver has 5 certificates. Among them, these include: ISO 13485:2016 Lead Auditor, Six Sigma Black Belt, and Six Sigma Green Belt.

What is the availability of Oliver?

Oliver is immediately available full-time for suitable projects.

What is the rate of Oliver?

Oliver's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.

How to hire Oliver?

To hire Oliver, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

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Market avg: 1100-1260 €
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Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.