Manufacturing Operations Specialist

Vor 3 Tagen

Schachen LU, Luzern, Schweiz nemensis ag Vollzeit

**Company Overview**

At nemensis ag, we are a specialized recruitment partner in the Life Sciences sector, providing comprehensive guidance and support to our clients. With years of experience in connecting applicants with their dream jobs, we have established a large network of clients and exciting opportunities in the northwest of Switzerland.

**Job Summary**

We are seeking a highly skilled Manufacturing Operations Specialist to join our team. As a key member of our operations department, you will be responsible for the practical execution, setup, and troubleshooting of upstream, downstream, and support processes in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP) conditions.

**Responsibilities**

* Practical execution, setup, and troubleshooting of upstream, downstream, and support processes in continuous manufacturing and fed-batch processes under GMP conditions
• Adherence to and application of GMP guidelines and Environmental, Health, and Safety (EHS) standards within the area of responsibility
• Management and documentation of process execution, deviations, changes, and Corrective Action Preventative Actions (CAPAs) in collaboration with Quality Assurance and other internal stakeholders
• Support for continuous improvement initiatives and the introduction of new technologies, including non-GMP testing or engineering runs
• Creation and updates of Standard Operating Procedures (SOPs) and electronic master batch records, as well as technical review of documentation related to process transfer and GMP manufacturing
• Material management using Enterprise Resource Planning (ERP) systems such as SAP
• Participation in sampling activities or on-call duties, which may include weekend work

**Requirements**

To succeed in this role, you will need:

  • Bachelor's or Master's degree in a relevant field
  • 1-2 years of experience in a GMP environment within the pharmaceutical or biotech industry
  • Practical knowledge or experience in upstream or downstream processing, along with a general understanding of biologic manufacturing processes and GMP regulations
  • Familiarity with quality management systems such as Trackwise, SAP Quality Management, or VeevaVault
  • Experience working with automated manufacturing systems (e.g., DeltaV) or electronic batch records (e.g., Manufacturing Execution System)
  • Background in process development or scale-up is an advantage
  • Strong problem-solving skills with the ability to approach challenges from new perspectives
  • Ability to perform effectively under pressure in a complex GMP setting, coupled with a strong desire for continuous learning and improvement
  • Proficiency in English (C1) and a good command of German (B2), both written and spoken

**Benefits**

As a valued member of our team, you can expect:

  • Nemensia g provides individualized assistance and guidance during the application process
  • We offer access to a large network of clients and exciting job opportunities in the northwest of Switzerland
  • Our company offers comprehensive guidance and support throughout the application process by our consultants

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