Associate Manufacturing Operations Specialist

vor 2 Wochen


Luzern, Schweiz Aristo Group Vollzeit
Associate Manufacturing Operations Specialist

This is a(n) (Associate) Specialist position within the Manufacturing Operations group at our company in the greater Lucerne area. This position requires full-time physical presence at the site to support manufacturing and to enable optimal integration into an existing team.

As a member of the growing manufacturing team at our client, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

Branche: Biotech

Responsibilities would primarily entail, but are not limited to, the following:

  • 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
  • Mentoring and training of junior team members, active participation in knowledge transfer
  • Participation in sampling activities or on-call duties, which may include weekend work

To be successful in this role, you will have the following:

  • Educational background in a relevant discipline
  • A minimum of 2-5 years of work experience in the pharmaceutical or biotech industry
  • A minimum of 2 years of practical experience in the manufacturing of biologics under GMP, either in upstream or downstream processing or support operations
  • Expert knowledge of some unit operations in upstream or downstream processing of biologics. Prior experience with continuous manufacturing is desirable, but not required
  • 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 bachelor’s or master’s degree in a relevant discipline
  • 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
Seniority level

Associate

Employment type

Contract

Job function

Production and Engineering

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