Step into a pivotal role at a global CMO and help shape the future of healthcare manufacturing.

Proclinical is seeking a Senior Bioprocess Engineer to focus on operational readiness, process improvement, and the roll-out of new initiatives within microbial, bio-conjugates, or mammalian manufacturing. The successful candidate will play a key role in driving change management, assisting with tech transfers, and ensuring efficient production processes. This is an exciting opportunity for professionals passionate about innovation and collaboration in biopharmaceutical manufacturing.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Oversee operational activities in upstream, downstream, or bio-conjugates manufacturing, material planning, document preparation, training, troubleshooting, and deviation handling.
• Lead the roll-out of new SAP functionalities, ensuring thorough updates to manufacturing documentation such as SOPs and batch records.
• Act as a functional lead for interdisciplinary teams, ensuring successful project execution and initiative roll-outs.
• Develop and implement training documentation for manufacturing personnel, plant logistics, and other related areas.
• Guide and assist clinical and/or commercial manufacturing activities in defined downstream processing (DSP) areas, such as capture, purification, polishing, or drug substance filling.
• Ensure efficient operation of single-use or stainless-steel equipment for therapeutic protein purification or bio-conjugate manufacturing (e.g., Antibody Drug Conjugates).

Key Skills and Requirements:

• Degree in Biotechnology, Biochemical Engineering, Biochemistry, or a related life science field.
• Expertise in downstream processing or bio-conjugates manufacturing, including chromatography, ultrafiltration/diafiltration, and dead-end filtration.
• Strong understanding of GMP regulations.
• Proficiency in SAP, particularly in material management and BOM aspects.
• Experience with MES systems as an end-user.
• Proven ability to create and support training documentation.
• Excellent communication skills in English and/or German.
• Strong project management skills and a structured, solution-oriented working style.
• Team-oriented mindset with the ability to collaborate effectively across departments.
  

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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