Manufacturing Operations Specialist

vor 3 Stunden


Schachen LU, Luzern, Schweiz nemensis ag Vollzeit
Overview
At nemensis ag, we specialize in Life Sciences recruitment. As a Manufacturing Operations Specialist, you will be part of our team in Basel, Northwestern Switzerland.

Key Responsibilities:
• Establish, execute, and troubleshoot upstream, downstream, and support unit operations in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP).

• Ensure compliance to GMP principles and Environmental, Health, and Safety (EHS) standards within the area of responsibility.

• Manage and document process execution, deviations, changes, and Corrective Action and Preventative Actions (CAPAs).

• Collaborate with Quality Assurance and other internal stakeholders during investigations and technical discussions.

• Contribute to continuous improvement efforts and support the implementation of new technologies, including non-GMP engineering runs or testing activities.

• Develop and update Standard Operating Procedures (SOPs) and electronic master batch records.

• Review various documentation related to process transfer and GMP manufacturing.

• Utilize Enterprise Resource Planning (ERP) systems (SAP) for material management.

• Mentor and train junior team members, actively participating in knowledge transfer.

• Participate in sampling activities or on-call duties, which may include weekend work.

Qualifications:
- Bachelor's or Master's degree
- 2-5 years of experience in the pharmaceutical or biotech industry
- At least 2 years of practical experience in GMP biologics manufacturing (upstream/downstream/support operations)
- Expert knowledge in certain unit operations of biologics processing
- Problem-solving skills and ability to learn and improve in a complex GMP environment
- Fluency in English (C1) and German (B2)
- Experience with quality management systems (Trackwise/SAP QM/VeevaVault)
- Familiarity with automated manufacturing systems (DeltaV) or electronic batch records (MES)
- Experience with process development or scale-up
- Ability to work well in a team and independently.

Benefits:
- Nemensis ag is your specialized recruitment partner in Life Sciences based in Basel
- Comprehensive advice and support throughout the application process by our consultants
- Access to a broad network of clients and exciting positions in Northwestern Switzerland
- Quick and seamless onboarding with personalized guidance and support during the application process.

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