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12209en
- Contract
- English
- Mid-Senior level
- Engineering & Technical Services
- Aarau
- Healthcare & Life Sciences
Skills
Validation, Quality, GMP, utilities, process
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About our client
For our client, one of the leading Healthcare & Life Sciences companies based in Solothurn, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Validation Engineer. This is a contract position for at least 6 months with the possibility of extension.
Your mission:
- Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation
- Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation
- Management and co-ordination of validation activities with internal departments, external contractors and suppliers
- Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities
- Primary point of contact for validation related issues arising during validation activities (including protocol execution)
- Investigation of deviations / non-conformances to determine impact on product quality, validation status and associated compliance requirements.
The ideal candidate:
- 3-7 years of experience in a Validation/Quality role in a biopharmaceutical manufacturing environment.
- Green/brown field project experience a great plus
- Thorough knowledge of biotechnological technologies, processes and clean utilities.
- Demonstrated proficiency in Good Practice requirements (GMP, GEP) as well as biopharmaceutical industry regulations and norms as they relate to validation.
- Strong technical writing and communication skills in English, German an advantage
Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to fiona.maqi@swisslinx.com.
We look forward to hearing from you!
For our client, one of the leading Healthcare & Life Sciences companies based in Solothurn, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Validation Engineer. This is a contract position for at least 6 months with the possibility of extension.
Your mission:
- Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation
- Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation
- Management and co-ordination of validation activities with internal departments, external contractors and suppliers
- Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities
- Primary point of contact for validation related issues arising during validation activities (including protocol execution)
- Investigation of deviations / non-conformances to determine impact on product quality, validation status and associated compliance requirements.
The ideal candidate:
- 3-7 years of experience in a Validation/Quality role in a biopharmaceutical manufacturing environment.
- Green/brown field project experience a great plus
- Thorough knowledge of biotechnological technologies, processes and clean utilities.
- Demonstrated proficiency in Good Practice requirements (GMP, GEP) as well as biopharmaceutical industry regulations and norms as they relate to validation.
- Strong technical writing and communication skills in English, German an advantage
Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to fiona.maqi@swisslinx.com.
We look forward to hearing from you!
