Manufacturing Operations Specialist
Infos sur l'emploi
- Date de publication :18 février 2025
- Taux d'activité :100%
- Type de contrat :Temporaire
- Langue :anglais (Courant), allemand (Intermédiaire)
- Lieu de travail :Schachen
Jobdescription
For our client, an international pharmaceutical company, we are looking for a Manufacturing Operations Specialist.
General Information:
This is a(n) (Associate) Specialist position within the Manufacturing Operations group in the greater Lucerne area. This position requires full-time physical presence at the site to support manufacturing.
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 & Responsibilities:
For our client, an international pharmaceutical company, we are looking for a Manufacturing Operations Specialist.
General Information:
- Start date: 01.04.2025
- End date: 31.03.2026
- Workplace: Schachen, Lucerne
- Workload: 100%
- Remote/Home office: Not available
This is a(n) (Associate) Specialist position within the Manufacturing Operations group in the greater Lucerne area. This position requires full-time physical presence at the site to support manufacturing.
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 & Responsibilities:
- 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).
- 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.
- Material management using ERP systems (SAP).
- 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.
- 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.
- Effective oral / written communication skills in English (C1).
- Oral / written communication skills in German (B1-B2).
- 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.
Walentyna Dobrowolska
