Direct message the job poster from K-Recruiting Life Sciences
Overview
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.
Responsibilities
* 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
* 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.
Qualifications
* 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
Duration: 12 months
Seniority level
* Associate
Employment type
* Full-time
Job function
* Industries
* Pharmaceutical Manufacturing
Note: This job posting is part of K-Recruiting Life Sciences recruitment efforts and may include standard employer information. End of listing.
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