Associate Specialist Process Operations (M/F/D)

Associate Specialist Process Operations (M/F/D)

Associate Specialist Process Operations (M/F/D)

Associate Specialist Process Operations (M/F/D)

K-Recruiting GmbH

Personaldienstleistungen und -beratung

Werthenstein

  • Art der Anstellung: Vollzeit
  • Vor Ort
  • Zu den Ersten gehören

Associate Specialist Process Operations (M/F/D)

Über diesen Job

Associate Specialist Process Operations (m/f/d)

Pharma & Biotech

Associate Specialist Process Operations (M/F/D)

This is an Associate Specialist position within the Process Operations group with a focus on upstream operations. 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, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

Tasks:

  • Set up, practical execution and troubleshooting of upstream 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

  • 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

  • Material management using ERP systems (SAP)

  • Participation in sampling activities (including occasional weekend work) or on-call duties, as required by the process scheduling. Typical manufacturing activities do not include shift work.

Qualification:

  • Educational background in a relevant discipline

  • A minimum of 0-2 years of work experience in the pharmaceutical or biotech industry.

  • 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 and assume responsibility. Flexible attitude when working with internal or external stakeholders to achieve ambitious targets.

  • Business Fluent in English and German:

  • Effective oral / written communication skills in German (C1)

  • Oral / written communication skills in English (B2+)

  • Residence within approximately 30 minutes commuting distance from Schachen (LU) or willingness to relocate

  • Driver’s license (B) and access to a personal car to enable on-call duties

  • Preferred Experience and Skills:

  • A bachelor’s or master’s degree in a relevant discipline

  • Prior experience in the manufacturing of biologics under GMP, ideally including experience operating a bioreactor

  • Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X)

Requirements:

Start : 01.10.2025

Unternehmens-Details

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K-Recruiting GmbH

Personaldienstleistungen und -beratung

51-200 Mitarbeitende

München, Deutschland

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Flexible Arbeitszeiten
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