To support the expansion of our client portfolio, we are currently hiring a Senior Process Engineer for a contract assignment with one of our client in the Basel region.
In this position, you will take ownership of a portfolio of commercial products, overseeing technology transfer and re-transfer activities between manufacturing sites. Your focus will be on ensuring GMP compliance and meeting client-specific requirements, while acting as a central technical point of contact.
Key Responsibilities
* Oversee and execute Process Design and Process Validation related to aseptic filling
* Coordinate product lifecycle activities, ensuring efficient transitions between sites and alignment with client expectations.
* Represent the technical function in cross-functional teams, serving as the main liaison between the CDMO and external stakeholders.
* Create, review, and approve documentation such as validation reports, protocols, risk assessments, and change controls.
* Lead investigations into process deviations, applying root cause analysis and implementing corrective actions.
* Identify and implement process improvements to enhance efficiency, robustness, and compliance.
* Provide support during audits and inspections, particularly those focused on aseptic operations and product transfers.
Your Profile
* Educational background in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.
* At least 5 years of hands-on experience in process engineering and tech transfer within aseptic Filling Line
* In-depth understanding of GMP regulations, aseptic techniques, and commercial product management.
* Previous experience in a CDMO environment is highly advantageous.
* Strong interpersonal and project coordination skills, with the ability to manage multiple stakeholders.
* Proficiency in English (C1 level); knowledge of French or German is considered a plus.
Desired Skills and Experience
To support the expansion of our client portfolio, we are currently hiring a Senior Process Engineer for a contract assignment with one of our client in the Basel region.
In this position, you will take ownership of a portfolio of commercial products, overseeing technology transfer and re-transfer activities between manufacturing sites. Your focus will be on ensuring GMP compliance and meeting client-specific requirements, while acting as a central technical point of contact.
Key Responsibilities
* Oversee and execute Process Design and Process Validation related to aseptic filling
* Coordinate product lifecycle activities, ensuring efficient transitions between sites and alignment with client expectations.
* Represent the technical function in cross-functional teams, serving as the main liaison between the CDMO and external stakeholders.
* Create, review, and approve documentation such as validation reports, protocols, risk assessments, and change controls.
* Lead investigations into process deviations, applying root cause analysis and implementing corrective actions.
* Identify and implement process improvements to enhance efficiency, robustness, and compliance.
* Provide support during audits and inspections, particularly those focused on aseptic operations and product transfers.
Your Profile
* Educational background in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.
* At least 5 years of hands-on experience in process engineering and tech transfer within aseptic Filling Line
* In-depth understanding of GMP regulations, aseptic techniques, and commercial product management.
* Previous experience in a CDMO environment is highly advantageous.
* Strong interpersonal and project coordination skills, with the ability to manage multiple stakeholders.
* Proficiency in English (C1 level); knowledge of French or German is considered a plus.