Early-Phase GMP Upstream Specialist

MSD; Lavamünd; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

MSD is seeking a Specialist Upstream Operations to join our Schachen Biotech site on a full‑time basis, based in Austria. You will integrate into an existing manufacturing team, responsible for GMP‑compliant upstream operations for early‑phase biologics and for supporting process transfer and documentation.

You will work with SAP QM, DeltaV, and PAS‑X in a regulated environment, mentoring junior colleagues and contributing to continuous improvement initiatives.

Qualifikationen

• 2–5 years in pharma/biotech, with GMP biologics experience.
• Experience with unit operations in upstream processing; continuous manufacturing preferred.
• Fluency in English and German (C1 / B2).
• Familiarity with quality systems and deviation management.

Aufgaben

• Set up and troubleshoot upstream operations in fed-batch GMP processes.
• Ensure GMP/EHS compliance and document process execution, deviations, and CAPAs.
• Collaborate with QA and other stakeholders during investigations.
• Support new technologies and non-GMP engineering runs or testing.
• Create and review SOPs and electronic batch records; review transfer docs.
• Manage materials using ERP (SAP); mentor junior team members.
• Participate in sampling and on-call duties as needed.

Kenntnisse

upstream processing

GMP knowledge

data analysis

CAPA management

SOP documentation

SAP ERP

continuous manufacturing

problem solving

team mentoring

english/german bilingual

Ausbildung

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

Tools

SAP QM

VeevaVault

DeltaV

PAS-X

Jobbeschreibung

MSD is seeking a Specialist Upstream Operations to join our Schachen Biotech site on a full‑time basis, based in Austria. You will integrate into an existing manufacturing team, responsible for GMP‑compliant upstream operations for early‑phase biologics and for supporting process transfer and documentation.

You will work with SAP QM, DeltaV, and PAS‑X in a regulated environment, mentoring junior colleagues and contributing to continuous improvement initiatives.