Specialist Manufacturing Technologies

vor 1 Monat

Luzern, Schweiz Randstad Vollzeit
For our client, a pharmaceutical company based in Lucerne, we are looking for a passionate Process Engineer / Specialist Manufacturing Technologies & Engineering. 

As a member of the Manufacturing Technologies & Engineering group, the successful candidate will play a key role in implementing next-generation technologies to keep the company at the forefront of innovation in biologics development and clinical manufacturing.

General Information:
  • Start date: ASAP
  • Duration: 1 year
  • Extension: possible
  • Workplace: Lucerne
  • Workload: 100%
  • Home office: remote work is limited due to the projects and implementations led by the MT&E team

    Tasks & Responsibilities:
     
    • Supporting the introduction of novel and innovative solutions for biologics manufacturing within the facility
    • Managing capital requests and sourcing activities
    • Qualification of devices and equipment
    • Authoring standard operating procedures
    • Serving as a subject matter expert (SME) for newly implemented technologies and guiding their integration into routine production
    • Authoring protocols and conducting design of experiments to demonstrate the comparability of new technologies with legacy systems
    • Demonstrate excellent troubleshooting and problem-solving skills, as well as the ability to collaborate and work effectively within global and interdisciplinary teams
    • Demonstrate a desire for continuous learning, improvement, and development, while approaching problems from new perspectives
    • Providing support for the manufacturing of clinical supply drug substance, including resupply activities
    • Operating equipment according to batch records, sampling plans, and standard operating procedures
    • Collaborating with Facility Management and internal team members to ensure GMP compliance through routine monitoring, calibration, maintenance, and certifications of responsible equipment devices

      Your Profile:
       
      • A degree qualification in a relevant field (Science/Technical). An Advanced Degree (BSc or MSc) is desirable.
      • At least 3 years of experience working in a relevant academic or industry field.
      • Technical knowledge in biologics drug substance upstream operations, downstream operations, analytical testing, or process development.
      • Detailed understanding of general principles of equipment qualification.
      • Experience in cGMP in a sterile, vaccine, bulk, or finished goods pharmaceutical environment.
      • Knowledge of design and operation of automated systems, such as DeltaV.
      • Project management knowledge.
      • Proficient verbal and written communication skills in English (B2). Proficiency in German (B1) is desirable.
      • Ability to think logically and be proactive under pressure.
      • Ability to work effectively as part of a team and independently.

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