Process Engineer
Il y a 3 jours
Antwerp Flemish Region, VLG, Belgique
VIQI Group
Temps plein
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As part of our continued growth in Belgium, we are looking for
a Process Engineer specialized in isolator cycle development
to support a major player in the biopharmaceutical industry.
The project involves the introduction of new isolator technology in a cell therapy manufacturing environment, with a focus on cycle development and validation.
Your
responsibilities:
- Develop and optimize isolator cycles for aseptic manufacturing processes
- Define appropriate cycle parameters based on the materials introduced into the isolators
- Perform hands-on activities related to isolator cycle development and validation
- Support the execution and documentation of validation activities
- Troubleshoot technical issues and contribute to process optimization
- Collaborate with Process Engineering, MSAT and Validation teams
- Ensure compliance with GMP requirements and aseptic processing standards
Your profile
- Engineering degree in Process Engineering, Biotechnology, Pharmaceutical Engineering or a related field
- At least 3 years of hands-on experience with isolators in a pharmaceutical or biopharmaceutical environment
- Proven experience in isolator cycle development and validation
- Strong understanding of aseptic manufacturing processes and GMP requirements
- Practical technical expertise in isolator operation, beyond project coordination or management
- Experience in cell therapy or advanced therapy medicinal products (ATMPs) is a plus
- Professional proficiency in English
responsibilities:
- Develop and optimize isolator cycles for aseptic manufacturing processes
- Define appropriate cycle parameters based on the materials introduced into the isolators
- Perform hands-on activities related to isolator cycle development and validation
- Support the execution and documentation of validation activities
- Troubleshoot technical issues and contribute to process optimization
- Collaborate with Process Engineering, MSAT and Validation teams
- Ensure compliance with GMP requirements and aseptic processing standards
Your profile
- Engineering degree in Process Engineering, Biotechnology, Pharmaceutical Engineering or a related field
- At least 3 years of hands-on experience with isolators in a pharmaceutical or biopharmaceutical environment
- Proven experience in isolator cycle development and validation
- Strong understanding of aseptic manufacturing processes and GMP requirements
- Practical technical expertise in isolator operation, beyond project coordination or management
- Experience in cell therapy or advanced therapy medicinal products (ATMPs) is a plus
- Professional proficiency in English