Process Associate- Downstream

Next Generation (Ireland); Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

DeltaV

MES

OSIsoft PI Historian

SAP

TrackWise

Maximo

Education

Level 6 qualification in Engineering, Science, Biotechnology or Bioprocessing

Tools

DeltaV

MES

OSIsoft PI Historian

SAP

TrackWise

Maximo

Job description

Bioprocess Associate - Downstream Manufacturing

We are seeking a Bioprocess Associate - Downstream Manufacturing to join a leading biopharmaceutical manufacturing facility. The successful candidate will support large-scale commercial manufacturing operations, working closely with cross-functional teams to ensure safe, efficient, and compliant production processes.

Key Responsibilities

• Collaborate with Manufacturing Operations, Project Design, Commissioning, Qualification & Validation (CQV), Automation and CSV teams to support facility implementation and validation activities.


• Develop and maintain Standard Operating Procedures (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 manufacturing principles.


• Utilise process automation systems, including DeltaV, MES and OSIsoft PI Historian, alongside supporting business systems such as SAP, TrackWise and Maximo.


• Review manufacturing batch records and exception reports in collaboration with Quality teams.


• Support deviation investigations, quality audits and corrective and preventive actions (CAPAs).


• Identify and implement continuous improvement initiatives to enhance manufacturing efficiency, equipment performance and workplace safety.


• Maintain compliance with GMP, SOPs and applicable health and safety requirements.


• Familiarity with DeltaV, Manufacturing Execution Systems (MES) or similar process automation platforms.

Qualifications & Experience

• Minimum Level 6 qualification in Engineering, Science, Biotechnology, Bioprocessing or a related discipline preferred. Relevant experience in a regulated manufacturing environment will also be considered.


• 1-3+ years of hands-on downstream processing experience within a large-scale biopharmaceutical or pharmaceutical manufacturing facility.


• Experience in downstream bioprocessing or biologics manufacturing would be advantageous.


• Previous experience working within GMP-regulated or cleanroom manufacturing environments.


• Familiarity with DeltaV, Manufacturing Execution Systems (MES) or similar process automation platforms.

Working Arrangements

Shift Work: This position requires flexibility to work shifts supporting a 24/7 manufacturing operation.