Manufacturing Operations Specialist.

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

About the job: 

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.

Must-haves:

• 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).

Nice-to have: 

• 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.

If this sounds like you, we'd love to hear from you! Submit your CV today and join a leading pharmaceutical company driving innovation.