Biologics Manufacturing Engineer

Responsibilities:

• Supporting the introduction of novel and innovative solutions for biologics manufacturing within the facility
• Managing capital requests and sourcing activities
• Qualification of devices and equipment
• Authoring standard operating procedures
• Serving as a subject matter expert (SME) for newly implemented technologies and guiding their integration into routine production
• Authoring protocols and conducting design of experiments to demonstrate the comparability of new technologies with legacy systems
• Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams
• Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives
• Providing support for the manufacturing of clinical supply drug substance, including resupply activities
• Operating equipment according to batch records, sampling plans, and standard operating procedures
• Collaborating with Facility Management and internal team members to ensure GMP compliance through routine monitoring, calibration, maintenance, and certifications of responsible equipment devices

Qualifications:

• A degree qualification in a relevant field (Science/Technical). An Advanced Degree (BSc or MSc) is desirable. 
• At least 3 years of experience working in a relevant academic or industry field. 
• Technical knowledge in biologics drug substance upstream operations, downstream operations, analytical testing, or process development. 
• Detailed understanding of general principles of equipment qualification. 
• Experience in cGMP in a sterile, vaccine, bulk, or finished goods pharmaceutical environment. 
• Knowledge of design and operation of automated systems, such as DeltaV.
• Project management knowledge. 
• Proficient verbal and written communication skills in English (B2). Proficiency in German (B1) is desirable.

Contact:

Annika Schelp,

Branche: Pharma-Industrie

Funktion: Ingenieurwesen/Planung

Anstellungsart: Temporäre Arbeit