Manufacturing Operations Specialist

JobdescriptionFor our client, an international pharmaceutical company, we are looking for a Manufacturing Operations Specialist. General Information: Start date: 01.04.2025End date: 31.03.2026Workplace: Schachen, LucerneWorkload: 100%Remote/Home office: Not availableAbout 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.