Biologics Process Expert

vor 8 Stunden


Luzern, Luzern, Schweiz Randstad Vollzeit
About the Job

We are looking for a talented Process Engineer - II - P2 Specialist, Manufacturing Operations to join our team. As a key member of our Manufacturing Operations team, you will play a critical role in supporting GMP manufacturing activities.

Key Responsibilities
  • Develop and implement process improvements to ensure seamless integration within the existing team.
  • Collaborate with Quality Assurance and other internal stakeholders to manage documentation for process execution, deviations, changes, and CAPAs.
  • Support the implementation of new technologies, including non-GMP engineering runs or testing activities.
  • Develop and maintain 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).
  • Train and mentor junior team members and actively participate in knowledge transfer.
  • Participate in sampling activities or be on-call, including potential weekend duties.
Requirements
  • Educational background in a relevant discipline.
  • 2-5 years of experience in the pharmaceutical or biotech industry.
  • Minimum of 2 years of practical experience in the GMP manufacturing of biologics (upstream or downstream).
  • Expert knowledge in specific unit operations for biologics manufacturing.
  • Understanding of GMP principles and ability to work under pressure in a complex environment.
  • Fluent English communication skills (C1 level).
  • Intermediate German skills (B2 level). Candidates with German A1/B1 proficiency may be considered if other skills strongly align with the role.


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