CQV Engineer

CQV / Qualification Engineer – Pharmaceutical Manufacturing

Eastern Switzerland (Hybrid - 4 days on-site/week)

3 Months

ASAP / Short Notice

English (German/French advantageous)

We are supporting an established pharmaceutical engineering and equipment manufacturer in Switzerland seeking an experienced CQV / Qualification Engineer for an initial 3-month contract.

This is a hands-on, technically focused opportunity working with advanced pharmaceutical packaging machinery, supporting equipment qualification from initial design documentation through factory testing and customer acceptance.

The ideal consultant will have direct experience qualifying pharmaceutical packaging equipment
, strong knowledge of GMP requirements, and the ability to work independently with minimal onboarding.

• Develop and review technical design and qualification documentation based on User Requirement Specifications (URS).
• Prepare and execute test plans and qualification protocols for pharmaceutical packaging machinery.
• Support equipment qualification activities across DQ, FAT, SAT, IQ and OQ
  .
• Perform hands-on machine testing and qualification activities ahead of Factory Acceptance Testing (FAT).
• Review electrical schematics and technical drawings to support testing, troubleshooting and qualification.
• Work across different automated packaging machine configurations and adapt to equipment-specific functionality.
• Utilise internal validation systems and documentation tools to maintain GMP-compliant qualification records.
• Support Site Acceptance Testing (SAT) and qualification activities at customer facilities when required.

• Minimum 4+ years of relevant CQV, Qualification or Validation Engineering experience within pharmaceutical equipment or machinery.
• Direct hands-on experience with pharmaceutical packaging machines or automated pharmaceutical packaging lines.
• Strong practical experience with DQ, FAT, SAT, IQ and OQ documentation and test execution.
• Ability to interpret electrical schematics, machine drawings and technical documentation.
• Sound knowledge of GMP compliance and equipment qualification processes.
• Experience preparing qualification test plans and technical documentation from URS.
• A practical, technically confident approach with the ability to work independently and quickly adapt to new equipment.

• Previous experience working directly for a pharmaceutical packaging machinery manufacturer (OEM).
• Experience with specialised pharmaceutical packaging systems, including automated cartoning, assembly or comparable equipment.
• Experience with equipment from Optima or similar pharmaceutical machinery manufacturers
  .
• Experience supporting FAT/SAT activities from both the equipment manufacturer and pharmaceutical customer perspectives.
• German or French language skills.

This opportunity is particularly suited to an experienced, hands-on Qualification Engineer who enjoys working directly with sophisticated pharmaceutical equipment and taking ownership of qualification activities.