Operational Manufacturing Specialist
vor 14 Stunden
This is a temporary role through nemensis ag, offering the opportunity to work in a GMP environment and contribute to the success of a leading pharmaceutical or biotech company.
Key Responsibilities- Execute, set up, and troubleshoot upstream, downstream, and support processes in continuous manufacturing and fed-batch processes under GMP conditions.
- Adhere to and apply GMP guidelines and EHS standards within the area of responsibility.
- Manage and document process execution, deviations, changes, and CAPAs in collaboration with Quality Assurance and other internal stakeholders.
- Support continuous improvement initiatives and the introduction of new technologies, including non-GMP testing or engineering runs.
- Create and update SOPs and (electronic) master batch records, as well as technical review of documentation related to process transfer and GMP manufacturing.
- Manage materials using ERP systems such as SAP.
- Participate in sampling activities or on-call duties, which may include weekend work.
- 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., 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.
nemensis ag is your specialized recruitment partner in the Life Sciences sector, based in Basel. We have connected thousands of applicants with their dream jobs, providing opportunities for career development or re-entering the job market.
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