Biologics Upstream Operations Specialist

MSD Malaysia; Luzern; Hybrid; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. in Lucerne (Schachen/Werthenstein) seeks a Specialist Upstream Operations to support GMP manufacturing of early-stage biologics and to integrate with an existing team.

You will set up and execute upstream processes, manage deviations and CAPAs, and drive continuous improvement while collaborating with QA, IT systems, and manufacturing personnel. Fluency in English and German is preferred.

Qualifikationen

• 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.

Aufgaben

• Set up, practical execution and troubleshooting of upstream operations in fed-batch processes under GMP.
• Knowledge of GMP principles and EHS standards.
• Management and documentation of process execution, deviations, changes and CAPAs; partner with QA and internal stakeholders.
• Involvement in continuous improvement and support for new technologies, including non-GMP engineering runs.
• Creation and updates of SOPs and electronic master batch records; technical review of process transfer documentation.
• Material management using ERP systems (SAP).
• Mentoring and training of junior team members; participation in knowledge transfer.
• Participation in sampling activities or on-call duties; weekend work may be required.

Kenntnisse

GMP compliance

Deviations

CAPA

Data analysis

SAP

DeltaV

PAS-X

Biologics upstream

Waste/QA collaboration

Ausbildung

Bachelor’s or Master’s degree in a relevant discipline

Tools

SAP

DeltaV

PAS-X

VeevaVault

Jobbeschreibung

Merck & Co., Inc. in Lucerne (Schachen/Werthenstein) seeks a Specialist Upstream Operations to support GMP manufacturing of early-stage biologics and to integrate with an existing team.

You will set up and execute upstream processes, manage deviations and CAPAs, and drive continuous improvement while collaborating with QA, IT systems, and manufacturing personnel. Fluency in English and German is preferred.