Biotechnology Process Engineer

Vor 2 Tagen

Schachen LU, Luzern, Schweiz Randstad Professionals Vollzeit
Company Overview:

We are seeking a skilled professional to join our Manufacturing Operations team. This full-time, on-site position is focused on supporting GMP manufacturing activities and ensuring seamless integration within the existing team.

The successful candidate will have experience in setting up, executing, and troubleshooting upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines. They will also be responsible for managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.

In addition to their technical expertise, the ideal candidate will possess excellent communication skills, including fluent English (C1 level) and intermediate German (B2 level).

Key Responsibilities:

• Set up, execute, and troubleshoot upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
• Manage documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
• Contribute to continuous improvement initiatives and support the implementation of new technologies, including non-GMP engineering runs or testing activities.
• Create and update SOPs and electronic master batch records, as well as review technical documentation for process transfer and GMP manufacturing.
• Manage material using ERP systems (e.g., SAP).
• Participate in sampling activities or be on-call, including potential weekend duties.

Requirements:

• Educational background in a relevant discipline.
• 1-2 years of experience in the pharmaceutical or biotech industry.
• Familiarity with upstream or downstream processes and general knowledge of unit operations in biologics manufacturing.
• Understanding of GMP principles and the ability to work under pressure in a complex environment.
• Fluent English communication skills (C1 level).
• Intermediate German skills (B2 level).

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