Oliver Wulf - Specialist Planner / Cleanroom Planning Lead

Recommended expert

Hildisrieden, Switzerland

Experience

Jan 2022 - Present

4 years 1 month

Specialist Planner / Cleanroom Planning Lead

Major Aircraft Manufacturer

Start-up and commissioning of the cleanroom
Certification of the cleanroom

Jan 2020 - Present

6 years 1 month

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

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