Process Engineer I m/w/d

We are seeking an Associate Specialist, Downstream Operations to support GMP manufacturing activities for early-phase clinical therapies. As part of the manufacturing team, you will contribute to the execution of downstream processing operations while ensuring compliance with GMP, safety, and quality standards.

Art der Beschäftigung: Payroll

Branche: Biotech

Fähigkeiten: verfahrenstechnik,bioprocess

Projektstart: 01.10.2026

Projektdauer: 12 Monate

Auftragsvolumen: 0 Stunde(n) 

Key Responsibilities

• Execute and support GMP downstream manufacturing activities for clinical-stage biologic products.
• Operate and monitor downstream processing equipment and manufacturing systems.
• Perform batch documentation review and ensure accurate GMP-compliant record keeping.
• Support deviation investigations, CAPAs, change controls, and continuous improvement initiatives.
• Collaborate closely with Manufacturing, MSAT, QA, QC, Engineering, and Supply Chain teams.
• Maintain a safe working environment and support inspection readiness.

Requirements

• Bachelor's degree or completed technical apprenticeship in Biotechnology, Life Sciences, Bioprocess Engineering, or a related field.
• Initial experience in GMP manufacturing, bioprocessing, or pharmaceutical production preferred.
• Knowledge of downstream processing operations and GMP requirements.
• Strong teamwork, communication, and problem-solving skills.
• Ability to work full-time on-site in a manufacturing environment.

Preferred Experience

• Biologics, vaccines, or cell & gene therapy manufacturing.
• Electronic batch records (EBR/MES) and GMP documentation.
• Experience working in cross-functional manufacturing teams.