プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Georgios A.に依頼

Switzerland

Process & Chemical Engineer Process Development, Validation, Qualification

プロフィール概要

Passionate and motivated chemical-process engineer with demonstrated experience in validation strategy design, establishing validation master plan, process validation documentation (IQ, OQ, PQ). Process control design. Investigation and root-cause analysis of non-conforming batch data. Authoring and reviewing of SOPs derived from ISOs and GMPs. Technology transfer to CMOs. Process design and development using sensitivity analysis methodology. Data analysis and uncertainty modeling.

専門分野

• ☆ Heat Transfer & Calorimetry
• ☆ Fluid Mechanics
• ☆ Food Engineering
• ☆ Food Safety
• ☆ Food Processing
• ☆ Process Engineering
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Packaging Design

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, Technical Writing

Research Feasibility Study, Technology Scouting, Scientific and Technical Research

Consulting Operations Consulting, Manufacturing Consulting

Product Development Recipe Development, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Packaging Design, Prototyping

職務経験

Process Validation and Sterile Packaging Manager

Medela

4月 2025 - 現在

Senior Project Engineer

Freelance on Food Supplements sectors

7月 2024 - 現在

Lead Manufacturing Device Engineer

Veltist

7月 2023 - 6月 2024

Process Validation Manager

Bühler AG

7月 2018 - 10月 2023

Bioprocess Engineer

Bühler AG

9月 2017 - 2月 2019

Process Engineer

Bühler AG

5月 2016 - 10月 2017

Process Engineer

rqmicro

2月 2014 - 9月 2015

学歴

CAS Pharmaceutical

ETHZ - ETH Zurich - Switzerland

1月 2025 - 現在

M.Sc. Process Engineering

ETHZ - ETH Zurich - Switzerland

9月 2012 - 5月 2015

Dipl.-Ing. Chemical Engineering

Aristotle University of Thessaloniki

9月 2006 - 5月 2012

認定資格

• Sterile Packaging Validation

  Paconsult

  5月 2025 - 現在

• Validation & Process Control for E-Beam Sterilization

  DTU, Denmark

  1月 2025 - 現在

• Making biologic medicines for patients

  MITx

  8月 2024 - 現在

• Project Management

  Google

  7月 2023 - 現在

• Bioprocess & Cell Culture Development

  ZHAW

  8月 2018 - 現在