Associate Manufacturing Operations Specialist
vor 2 Wochen
This is a(n) (Associate) Specialist position within the Manufacturing Operations group at our company in the greater Lucerne area. This position requires full-time physical presence at the site to support manufacturing and to enable optimal integration into an existing team.
As a member of the growing manufacturing team at our client, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.
Branche: Biotech
Responsibilities would primarily entail, but are not limited to, the following:
- Set up, practical execution and troubleshooting of upstream, downstream and support unit operations in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP)
- Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
- Management and documentation of process execution, deviations, changes and CAPAs. Partnering with Quality Assurance and other internal stakeholders during investigations and technical discussions
- Involvement in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities
- Creation and updates of SOPs and (electronic) master batch records. Technical review of various documentation related to process transfer and GMP manufacturing
- Mentoring and training of junior team members, active participation in knowledge transfer
- Participation in sampling activities or on-call duties, which may include weekend work
To be successful in this role, you will have the following:
- Educational background in a relevant discipline
- A minimum of 2-5 years of work experience in the pharmaceutical or biotech industry
- A minimum of 2 years of practical experience in the manufacturing of biologics under GMP, either in upstream or downstream processing or support operations
- Expert knowledge of some unit operations in upstream or downstream processing of biologics. Prior experience with continuous manufacturing is desirable, but not required
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Ability to perform under pressure in a complex GMP environment.
- Business Fluent in English and German
- Effective oral / written communication skills in English (C1)
- Oral / written communication skills in German (B2)
Preferred Experience and Skills:
- A bachelor’s or master’s degree in a relevant discipline
- Experience with quality management and compliance systems (Trackwise/SAP QM/VeevaVault)
- Familiarity with the use of automated systems in manufacturing (DeltaV) or electronic batch records (MES)
- Prior experience with process development or process scale-up is beneficial
- Ability to work efficiently as part of a team, as well as willingness to take responsibility for independent projects
Associate
Employment typeContract
Job functionProduction and Engineering
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