Requirements: English
Company: K-Recruiting Life Sciences
Region: Werthenstein , Lucerne
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We unite the people who make our world healthier by placing top experts with life sciences companies worldwide. Fast and reliably, with the perfect
Associate Specialist Manufacturing Operations (M/F/D)
Tasks:
- 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
- Participation in sampling activities or on-call duties, which may include weekend work
Qualification:
- Educational background in a relevant discipline
- A minimum of 0-2 years of work experience in the pharmaceutical or biotech industry
- Experience (0-2 years) or educational background in upstream or downstream processing. General knowledge of unit operations in manufacturing processes for biologics and of GMP requirements
- 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 bachelors or masters degree in a relevant discipline
- 1-2 years of experience in a GMP environment
- 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
Requirements:
Start: 03.02.2025
Duration: 31.12.2026
Seniority level
Employment type
Job function
- Manufacturing
- Pharmaceutical Manufacturing
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