Manufacturing Operations Specialist
Vor 2 Tagen
nemensis ag is a specialized recruitment partner in the Life Sciences sector, based in Switzerland.
Key Responsibilities- Practical execution, setup, and troubleshooting of upstream, downstream, and support processes in continuous manufacturing and fed-batch processes under Good Manufacturing Practice (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 and 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.
- 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 QM, or VeevaVault.
- Experience working with automated manufacturing systems (e.g., DeltaV) or electronic batch records (e.g., Manufacturing Execution System (MES)).
- 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 (B1-B2), both written and spoken.
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