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Biotechnology Manufacturing Engineer
7 dagen geleden
About the Job: We are currently searching for a qualified MSAT Process Engineer to fill this exciting opportunity. As part of our team, you will have the chance to develop your expertise in automated bioprocessing and contribute to the success of a leading ATMP company.
Key Responsibilities:
- Develop advanced process validation plans, including process design, qualification, verification, and comparability.
- Lead global change control initiatives to ensure seamless operations across the network.
- Investigate and implement corrective actions to maintain high-quality standards.
- Create comprehensive process descriptions, SOPs, and training materials to support decentralised manufacturing.
- Collaborate with cross-functional teams to develop electronic batch records, procedures, and training programs.
- Monitor and improve process performance, equipment lifecycle, and reliability initiatives.
- Support regulatory submissions and respond to health authority queries related to technical processes and CMC.
Requirements:
- Bachelor's degree in Life Sciences, Biotech, or a related field with a minimum 7 years of relevant experience.
- Proven experience in cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, and process validation.
- Strong communication and collaboration skills, with fluency in English.
- Familiarity with data management tools and statistical process controls is advantageous.
- A results-driven approach with a focus on quality and compliance.
- Ability to manage multiple projects and adapt to changing priorities.
- Excellent interpersonal skills and written and spoken English fluency.
