Drug Product Manufacturing Engineer in Singen (Hohentwiel) bei Takeda Pharmaceutical

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Drug Product Manufacturing Engineer (m/f/d)

In this role you will work in an international team on exciting technical topics related to the global production of vaccines

Your main responsibilities:

• Manages technical topics related to the global manufacturing of drug product within scope of Vaccines Technical Operations Drug Product
• Collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to drive successful technology transfer from development to commercial production.
• Conduct thorough process risk assessments and implement strategies to ensure product quality and compliance with regulatory standards, with a particular emphasis on vaccine-specific requirements.
• Supporting technology transfer from process development to cGMP manufacturing and site transfers of commercial manufacturing processes as required meeting global demand forecasts
• Oversee and support process validation activities, including protocol generation, execution, and final report compilation, in accordance with cGMP guidelines and industry best practices.
• Provide technical expertise and hands-on support to the manufacturing team during vaccine production activities, including troubleshooting and resolution of process-related issues.
• Evaluate and implement new technologies and equipment in the vaccine production process to enhance efficiency, scalability, and compliance with industry standards.
• Stay abreast of industry trends and emerging technologies in vaccine manufacturing, contributing to the continuous improvement of our processes and capabilities.

Your profile:

• Bachelor’s degree in chemical engineering, Pharmaceutical Sciences, or related field. Master's degree preferred.
• 1-2 years of progressive experience in vaccine drug product manufacturing, with a strong emphasis on process development, optimization, and scale-up.
• In-depth knowledge of cGMP regulations, regulatory requirements, and industry standards specific to vaccine production.
• Scientific and technical knowledge regarding single use materials, formulation processes, aseptic filling, isolator technology, lyophilization and visual inspection
• Excellent command of English (both written and oral), German language knowledge is a plus.
• Strong analytical and problem-solving skills, coupled with meticulous attention to detail.
• Excellent communication and interpersonal skills, enabling effective collaboration across various departments and levels within the organization.
• Enthusiastic about contributing to a diverse and intercultural work environment.

In this position you will report to the Associate Director, Technical Operations VBU.