Biotechnology Process Development Engineer

We offer competitive salary and benefits packages, as well as opportunities for professional growth and development. If you are passionate about biotechnology and have a strong background in bioprocess development, we encourage you to apply for this exciting opportunity.

Location: Tartu, Estonia

Employment Type: Contract

Industry: Biotechnology

About the Role: We are seeking a highly motivated and experienced Biotechnology Process Development Engineer to join our dynamic team. In this role, you will be responsible for developing and optimizing bioprocesses for the production of pharmaceuticals, biopharmaceuticals, and other biotechnology products. You will work closely with cross-functional teams to design, scale-up, and troubleshoot bioprocesses, ensuring their efficiency, safety, and compliance with regulatory standards.

Key Responsibilities:

• Design and develop bioprocesses for the production of biotechnology products, including upstream and downstream processes.
• Conduct experiments and perform data analysis to optimize bioprocess conditions, such as media composition, temperature, and cell culture parameters.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Control, and Regulatory Affairs, to ensure the successful transition of processes from development to commercialization.
• Conduct technology transfer activities, including writing protocols and reports, to transfer processes to manufacturing sites.
• Troubleshoot process deviations and implement corrective actions to ensure process robustness and reproducibility.
• Stay updated with the latest developments in bioprocess technology and industry trends, and apply this knowledge to improve existing processes.
• Ensure compliance with regulatory requirements, including FDA and cGMP guidelines, throughout the development and optimization of bioprocesses.
• Participate in process validation activities and contribute to the preparation of related documentation.
• Mentor and train junior team members on bioprocess development techniques and best practices.
• Contribute to the development and improvement of processes and procedures to enhance the efficiency and effectiveness of the bioprocess development function.

Qualifications:

• Bachelor's or Master's degree in Biotechnology, Biochemical Engineering, or a related field.
• Minimum of 5 years of experience in bioprocess development in the biotechnology or pharmaceutical industry.
• Strong knowledge of upstream and downstream bioprocesses and equipment, such as bioreactors, chromatography, and filtration systems.
• Hands-on experience with process optimization and scale-up techniques, including Design of Experiments (DoE) and Statistical Process Control (SPC).
• Experience with process characterization, validation, and technology transfer activities.
• Familiarity with regulatory requirements, such as FDA and cGMP guidelines, for the development and manufacture of biotechnology products.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication and interpersonal skills, with the ability to work effectively in a cross-functional team.
• Proven ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.

Join our team and make a meaningful impact on the development of life-saving biotechnology products!.