Manufacturing Specialist (Pharma)
Location: Leiden, NetherlandsThe Company
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies and vaccines to protect people worldwide from immunological and infectious diseases.
Role Description
As a Manufacturing Specialist you will be responsible for the downstream process of vaccines production, focusing on the fill/finish equipment. You will make sure that the equipment is available for manufacturing, troubleshoot and conduct root-cause analysis whenever there is an issue. You will work closely with operators, GMP specialists, Maintenance department, Quality department and process engineers.
Responsibilities
- Troubleshooting and optimization of existing fill installation line for Covid19 vaccine.
- Start up new automated fill installation for Covid19 vaccine.
- Root cause investigations of complex deviations and for the implementation of preventive actions.
- Initiating and handling of compliance records (change controls, events, CAPA, deviations)
- Initiation and execution of test protocols
- As Equipment Owner, ensure that this is validated and with documentation up to date
- Monitor equipment status KPIs
Requirements
- Bachelor's or higher in Life Sciences or Engineering
- 5+ years of experience in a manufacturing environment within the biopharmaceutical industry
- Experience with 'Fill' processes and installations of biopharmaceutical products (10 litre scale, no vials)
- Knowledge of start up and automation of installations
- GMP experience
Other Information
1 year contract with possibility of extension.
Currently 50% on site, from mid-2022 100% on site.
For more information please contact Guilherme Tokunaga at g.tokunaga@sire-search.com or +31 (0) 20 658 98 01.
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies and vaccines to protect people worldwide from immunological and infectious diseases.
Role Description
As a Manufacturing Specialist you will be responsible for the downstream process of vaccines production, focusing on the fill/finish equipment. You will make sure that the equipment is available for manufacturing, troubleshoot and conduct root-cause analysis whenever there is an issue. You will work closely with operators, GMP specialists, Maintenance department, Quality department and process engineers.
Responsibilities
- Troubleshooting and optimization of existing fill installation line for Covid19 vaccine.
- Start up new automated fill installation for Covid19 vaccine.
- Root cause investigations of complex deviations and for the implementation of preventive actions.
- Initiating and handling of compliance records (change controls, events, CAPA, deviations)
- Initiation and execution of test protocols
- As Equipment Owner, ensure that this is validated and with documentation up to date
- Monitor equipment status KPIs
Requirements
- Bachelor's or higher in Life Sciences or Engineering
- 5+ years of experience in a manufacturing environment within the biopharmaceutical industry
- Experience with 'Fill' processes and installations of biopharmaceutical products (10 litre scale, no vials)
- Knowledge of start up and automation of installations
- GMP experience
Other Information
1 year contract with possibility of extension.
Currently 50% on site, from mid-2022 100% on site.
For more information please contact Guilherme Tokunaga at g.tokunaga@sire-search.com or +31 (0) 20 658 98 01.
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