Your role will be to contribute your expertise to our client on the Commissioning, Qualification and Validation (F/H) of new installations for pharmaceutical production.
We are looking for candidates with experience in QC on various types of installations (freeze-dryers / isolators / aseptic filling lines / SIP-CIP / autoclaves / washing machines / utilities / HVAC / clean rooms ...).
The project :
Elaborate the CQV strategy for a specific type of plant and be responsible for implementing the validation plan,
Comply with all applicable standards and SOPs (internal and external),
Ensure that suppliers comply with good documentation practices,
Support FAT/SAT commissioning phases,
Review of qualification documentation (design, IQ/OQ/PQ protocols and reports, traceability matrices, risk analyses),
Monitoring test execution,
Collaboration with various project teams to ensure that qualification/validation activities are carried out correctly,
Participate in inspections by the authorities.
You have a Bachelor's degree in engineering or an engineering diploma,
At least 5 years' experience in a pharmaceutical/biotech environment.
At least 5 years' experience in commissioning, qualification and validation.
Good knowledge of GMP standards,
Good knowledge of Good Documentation Practices.
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked 7th among consulting firms in French-speaking Switzerland. We have over 300 experienced engineers who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
By joining our teams you will discover :
You too can be part of the Antaes adventure!
Your role will be to contribute your expertise to our client on the Commissioning, Qualification and Validation (F/H) of new installations for pharmaceutical production.
We are looking for candidates with experience in QC on various types of installations (freeze-dryers / isolators / aseptic filling lines / SIP-CIP / autoclaves / washing machines / utilities / HVAC / clean rooms ...).
The project :
Elaborate the CQV strategy for a specific type of plant and be responsible for implementing the validation plan,
Comply with all applicable standards and SOPs (internal and external),
Ensure that suppliers comply with good documentation practices,
Support FAT/SAT commissioning phases,
Review of qualification documentation (design, IQ/OQ/PQ protocols and reports, traceability matrices, risk analyses),
Monitoring test execution,
Collaboration with various project teams to ensure that qualification/validation activities are carried out correctly,
Participate in inspections by the authorities.
You have a Bachelor's degree in engineering or an engineering diploma,
At least 5 years' experience in a pharmaceutical/biotech environment.
At least 5 years' experience in commissioning, qualification and validation.
Good knowledge of GMP standards,
Good knowledge of Good Documentation Practices.
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked 7th among consulting firms in French-speaking Switzerland. We have over 300 experienced engineers who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
By joining our teams you will discover :
You too can be part of the Antaes adventure!