GMP Manufacturing Engineer

vor 1 Tag


Luzern, Luzern, Schweiz Randstad Vollzeit
Job Description

As a skilled Process Engineer - II - P2 Specialist, Manufacturing Operations, you will play a critical role in supporting GMP manufacturing activities and ensuring seamless integration within the existing team.

Responsibilities:
  • Setting up, executing, and troubleshooting upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
  • Managing documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
  • Contributing to continuous improvement initiatives and supporting the implementation of new technologies, including non-GMP engineering runs or testing activities.
  • Creating and updating SOPs and electronic master batch records, as well as reviewing technical documentation for process transfer and GMP manufacturing.
  • Mentoring and training junior team members and actively participating in knowledge transfer.

Requirements:
  • Relevant educational background.
  • 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.
  • Fluent English communication skills (C1 level).
  • Intermediate German skills (B2 level).


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