CQV Engineer

ARTO; München; On-site; EUR 76,000 - 117,000; Full time

Job summary

ARTO is seeking an experienced CQV Engineer to support a pharmaceutical manufacturing project in Munich. The role focuses on hands-on Commissioning, Qualification & Validation (CQV) activities, with emphasis on aseptic fill-finish equipment and related sterile manufacturing systems.

Candidates with CQV experience on GMP equipment are encouraged to apply. You will execute FAT, SAT, IQ and OQ, prepare and review qualification documentation, and perform on-site testing while ensuring GMP

Qualifications

• Demonstrated CQV experience in pharmaceutical manufacturing.
• Hands-on qualification activities including FAT/SAT/IQ/OQ.
• Strong GMP knowledge and qualification documentation practices.
• Ability to work independently on-site in Munich and communicate in German.

Responsibilities

• Execute qualification activities including FAT, SAT, IQ and OQ for pharmaceutical manufacturing equipment.
• Prepare, review and execute qualification protocols, test documentation and reports.
• Perform hands-on equipment testing, troubleshooting and qualification on-site.
• Manage qualification deviations, technical issues and associated documentation.
• Collaborate with Engineering, Manufacturing, QA and equipment suppliers.

Skills

CQV experience

Documentation skills

On-site testing

German language

Tools

FAT

SAT

IQ

OQ

Job description

CQV Engineer - Pharmaceutical Manufacturing

Contract: 6 months initially | On-site

Start: ASAP / Short notice preferred

Sector: Pharmaceutical Manufacturing / GMP

The Opportunity

We are recruiting an experienced CQV / Qualification Engineer (Qualifizierungsingenieur) to support a pharmaceutical manufacturing project in Munich, Germany.

The assignment focuses on hands-on Commissioning, Qualification & Validation (CQV) activities, particularly the qualification of aseptic filling lines (fill-finish) and associated sterile manufacturing equipment. Qualification Engineers with relevant experience on other GMP manufacturing equipment are also encouraged to apply.

Key Responsibilities

• Execute qualification activities including FAT, SAT, IQ and OQ for pharmaceutical manufacturing equipment.
• Prepare, review and execute qualification protocols, test documentation and reports.
• Perform hands-on equipment testing, troubleshooting and qualification on-site.
• Manage qualification deviations, technical issues and associated documentation.
• Collaborate with Engineering, Manufacturing, QA and equipment suppliers.
• Ensure qualification activities comply with GMP requirements and site procedures.

Experience Required

• Practical CQV, equipment qualification or validation experience within pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience executing FAT, SAT, IQ and/or OQ activities.
• Strong understanding of GMP requirements and qualification documentation.
• Ability to independently execute technical qualification activities.
• Professional working proficiency in German.
• Ability to work on-site in Munich, with appropriate authorisation to undertake the contract assignment in Germany.

Experience in any of the following areas would be advantageous:

• Aseptic filling lines / Fill & Finish
• Isolators and sterile manufacturing equipment
• Pharmaceutical process equipment
• Autoclaves, washers and sterilisation systems
• EU GMP Annex 1 environments