Senior Bioprocess Engineer m/w/d

Aristo Group; Luzern; On-site; CHF 130,000 - 180,000; Full time

Job summary

Aristo Group seeks a Senior Bioprocess Engineer to lead operational activities in Upstream/Downstream or BioConjugates manufacturing, including tech transfer support, material planning, document and batch record preparation, training and troubleshooting. You will drive the rollout of new SAP functionality and maintain manufacturing documentation (SOPs, batch records).

You will act as a functional lead for an interdisciplinary team and ensure successful project outcomes; you will establish

Qualifications

• 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 biotech/biopharma (chromatography, ultrafiltration/diafiltration, dead-end filtration).
• Very good GMP understanding.
• Strong experience in SAP; material management (BOM).
• Proficient knowledge of production logistics workstreams and MES End-User experience.
• Excellent communication skills in English and/or German.
• Strong team orientation; structured, organized and solution-focused mindset.

Responsibilities

• Manage operational activities in Upstream and Downstream or BioConjugates manufacturing, including tech transfer support, material planning, document and batch record preparation, training and troubleshooting, deviation handling.
• Lead rollout of new SAP functionality; update manufacturing documentation (SOPs, batch records).
• Act as a functional lead for interdisciplinary teams and drive successful roll-out of initiatives and projects.
• Create training documentation for manufacturing personnel, plant logistics and related areas.
• Guide clinical and/or commercial manufacturing in defined DSP areas (capture, purification, filling).
• Ensure efficient operation of single-use and stainless steel equipment for purification of therapeutic proteins or BioConjugates like ADCs.

Skills

GMP understanding

English and German communication

Team orientation

Structured working

End-User MES

Education

Bachelor, Master’s Degree or PhD in Biotechnology, Bio-chemical Engineering, Biochemistry or related Life Science subject

Tools

SAP

BOM

MES

Job description

• 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
• , 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)