Senior Bioprocess Engineer m/w/d

Aristo Group; Luzern; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Aristo Group in Switzerland seeks an experienced Senior Bioprocess Engineer to manage operations in Upstream and Downstream or BioConjugates manufacturing, including tech transfer support, material planning, and batch record preparation.

The role focuses on rolling out new SAP functionality, updating SOPs, training manufacturing personnel, and leading cross-functional teams to ensure compliant, efficient processes for therapeutic proteins or ADCs.

Qualifikationen

• Bachelor, Master’s or PhD in Biotechnology, Biochemical Engineering, Biochemistry or related Life Science subject.
• Significant work experience in Downstream Processing or BioConjugates Manufacturing in the biotech/biopharma industry.
• Excellent GMP understanding and cross-functional collaboration.

Aufgaben

• Manage operational activities in Upstream, Downstream and BioConjugates manufacturing.
• Support tech transfer, material planning, and batch record/document preparation.
• Lead training, troubleshooting, deviation handling, and change management for SAP rollout.
• Coordinate with interdisciplinary teams and ensure compliant, efficient production.
• Develop training documentation for manufacturing personnel.

Kenntnisse

GMP understanding

Logistics knowledge

English/German communication

Team orientation

Change management documentation

Material management

Ausbildung

Bachelor, Master’s or PhD in Biotechnology, Biochemical Engineering, Biochemistry or related Life Science subject

Tools

SAP

MES

BOM management

Jobbeschreibung

• As Senior Bioprocess Engineer, you will manage operational activities in Upstream and Downstream or BioConjugates manufacturing, e.g. tech transfer support, material planning, document and batch record preparation, training and troubleshooting, deviation handling
• As your key entry role is focusing on the role out of new SAP functionality, a strong expertise in Change Management documentation as well as thorough updates of manufacturing documentation (e.g. SOPs, batch records) is key
• In this role, you will act as a functional lead for an interdisciplinary team of production personnel, supervisors and specialists and be accountable for the successful roll-out of new initiatives, i.e. performance and results of assigned projects
• Establish training documentation for manufacturing personnel, plant logistics and (as needed) other manufacturing related areas
• Guide and support activities for clinical and/or commercial manufacturing in one or more defined DSP areas, e.g. capture, intermediate purification, polishing or drug substance filling
• Ensure implementation of procedures which enable efficient operation of single-use and/or stainless steel equipment for the purification of therapeutic proteins from either microbial or mammalian expression systems (Bioprocess Engineer DSP) or for the manufacturing of therapeutic BioConjugates like Antibody Drug Conjugates (ADCs) (Bioprocess Engineer BioConjugates)

Key requirements:

• Bachelor, Master’s Degree or PhD in Biotechnology, Bio-chemical Engineering, Biochemistry or related Life Science subject
• Significant work experience in Downstream Processing or BioConjugates Manufacturing in the biotech/biopharma industry e.g. chromatography, ultra-/diafiltration and dead-end filtration
• Very good GMP understanding
• Strong experience in SAP, aspects of material management (BOM)
• Profound knowledge of logistics workstreams within production
• Profound knowledge as End-User of MES
• Excellent communication skills in English and/or German
• Strong team orientation
• Structured, well-organized working attitude and solution-oriented working style
• Open-minded for new ideas and suggestions

• As Senior Bioprocess Engineer, you will manage operational activities in Upstream and Downstream or BioConjugates manufacturing, e.g. tech transfer support, material planning, document and batch record preparation, training and troubleshooting, deviation handling
• As your key entry role is focusing on the role out of new SAP functionality, a strong expertise in Change Management documentation as well as thorough updates of manufacturing documentation (e.g. SOPs, batch records) is key
• In this role, you will act as a functional lead for an interdisciplinary team of production personnel, supervisors and specialists and be accountable for the successful roll-out of new initiatives, i.e. performance and results of assigned projects
• Establish training documentation for manufacturing personnel, plant logistics and (as needed) other manufacturing related areas
• Guide and support activities for clinical and/or commercial manufacturing in one or more defined DSP areas, e.g. capture, intermediate purification, polishing or drug substance filling
• Ensure implementation of procedures which enable efficient operation of single-use and/or stainless steel equipment for the purification of therapeutic proteins from either microbial or mammalian expression systems (Bioprocess Engineer DSP) or for the manufacturing of therapeutic BioConjugates like Antibody Drug Conjugates (ADCs) (Bioprocess Engineer BioConjugates)

Key requirements:

• Bachelor, Master’s Degree or PhD in Biotechnology, Bio-chemical Engineering, Biochemistry or related Life Science subject
• Significant work experience in Downstream Processing or BioConjugates Manufacturing in the biotech/biopharma industry e.g. chromatography, ultra-/diafiltration and dead-end filtration
• Very good GMP understanding
• Strong experience in SAP, aspects of material management (BOM)
• Profound knowledge of logistics workstreams within production
• Profound knowledge as End-User of MES
• Excellent communication skills in English and/or German
• Strong team orientation
• Structured, well-organized working attitude and solution-oriented working style
• Open-minded for new ideas and suggestions