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.

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.