Position Summary
The USP Operator supports the manufacturing of biopharmaceutical Drug Substance in a GMP-regulated environment. The role is responsible for executing upstream processing activities including inoculum expansion, bioreactor operation, sampling, process monitoring, cleaning activities, and GMP compliant documentation. This position is designed for entry-level candidates seeking to develop technical expertise in mammalian cell culture manufacturing within a Contract Development and Manufacturing Organization (CDMO).
Key Responsibilities
Manufacturing Operations
- Perform upstream manufacturing activities according to GMP requirements, approved procedures, and batch records
- Execute inoculum expansion and mammalian cell culture operations
- Assist in the operation and monitoring of single-use bioreactors up to the 2000L scale
- Perform process sampling and basic analytical testing according to procedures
- Monitor process parameters and report deviations or unusual observations
- Support setup, assembly, disassembly, cleaning, and preparation of process equipment
- Ensure manufacturing areas remain inspection-ready and compliant with GMP requirements
Documentation & Compliance
- Complete batch records and GMP documentation accurately and contemporaneously
- Adhere to Standard Operating Procedures (SOPs), work instructions, and safety requirements
- Support deviation investigations by providing factual information and documentation
- Participate in training programs and maintain required qualifications
- Follow data integrity principles and good documentation practices (GDP)
Continuous Improvement
- Contribute to operational excellence initiatives
- Identify opportunities to improve safety, quality, compliance, and efficiency
- Participate in team meetings and knowledge-sharing activities
Key Requirements
Education
- Completed vocational training, apprenticeship, technician qualification, or bachelor's degree in Biotechnology, Biology, Bioprocess Engineering, Pharmaceutical Technology, Chemical Engineering or related scientific discipline
Preferred Experience
- Initial practical experience through internships, apprenticeships, laboratory work, or industrial placements in biotechnology or pharmaceutical manufacturing with exposure to cell culture techniques, Bioreactor systems, Single-use technologies, GMP-regulated environments
- Foundational knowledge of Mammalian cell culture, Upstream processing, Bioreactors, Aseptic techniques, Process monitoring systems
Behavioral Competencies
- Strong attention to detail, Commitment to quality and compliance, Team-oriented mindset, Reliable and accountable work ethic, Effective communication skills, Continuous learning attitude, Safety-conscious behavior, Ability to work in a fast-paced manufacturing environment
Production Associate in Wuppertal Arbeitgeber: WuXi Biologics
Als Arbeitgeber in der pharmazeutischen Industrie bietet unser Unternehmen am Standort Wuppertal eine dynamische und unterstützende Arbeitsumgebung, die auf Teamarbeit und individuelle Entwicklung setzt. Wir fördern eine Kultur der kontinuierlichen Verbesserung und bieten unseren Mitarbeitern umfangreiche Weiterbildungsmöglichkeiten sowie die Chance, in einem internationalen Umfeld zu arbeiten. Mit einem klaren Fokus auf Qualität und Compliance sind wir bestrebt, unseren Mitarbeitern ein bedeutungsvolles und erfüllendes Arbeitsumfeld zu bieten.
