Bioprocess Downstream Manufacturing Specialist (24/7 GMP)

Next Generation (Ireland); Dublin; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

Next Generation (Ireland) invites applications for a Bioprocess Associate – Downstream Manufacturing to support large-scale commercial biopharma production. You will collaborate with cross-functional teams to ensure safe, efficient, and compliant operations in a regulated CMO/biomanufacturing setting.

Key duties include SOP maintenance, batch record review, deviation investigations and CAPA support, while operating downstream processing equipment and integrating DeltaV, MES, and OSIsoft PI

Qualifikationen

• Minimum Level 6 qualification in Engineering, Science, Biotechnology or Bioprocessing.
• 1–3+ years of hands-on downstream processing in a large-scale facility.
• Experience in GMP-regulated environments and cleanrooms.
• Familiarity with DeltaV, MES or similar automation platforms.

Aufgaben

• Collaborate with Manufacturing Operations, CQV, Automation and CSV teams to support facility implementation and validation activities.
• Develop and maintain SOPs, work instructions and manufacturing documentation.
• Execute commercial biopharmaceutical manufacturing processes in accordance with established procedures and GMP requirements.
• Operate and monitor downstream manufacturing equipment within the assigned production area.
• Support process investigations, troubleshooting and optimisation using scientific, engineering and Lean principles.
• Utilise DeltaV, MES and OSIsoft PI Historian, alongside SAP, TrackWise and Maximo.
• Review manufacturing batch records and exception reports in collaboration with Quality teams.
• Support deviation investigations, quality audits and CAPAs.
• Identify and implement continuous improvement initiatives to enhance efficiency, equipment performance and safety.
• Maintain compliance with GMP, SOPs and applicable health and safety requirements.

Kenntnisse

DeltaV

MES

OSIsoft PI Historian

SAP

TrackWise

Maximo

Ausbildung

Level 6 qualification in Engineering, Science, Biotechnology or Bioprocessing

Tools

DeltaV

MES

OSIsoft PI Historian

SAP

TrackWise

Maximo

Jobbeschreibung

Next Generation (Ireland) invites applications for a Bioprocess Associate – Downstream Manufacturing to support large-scale commercial biopharma production. You will collaborate with cross-functional teams to ensure safe, efficient, and compliant operations in a regulated CMO/biomanufacturing setting.

Key duties include SOP maintenance, batch record review, deviation investigations and CAPA support, while operating downstream processing equipment and integrating DeltaV, MES, and OSIsoft PI