Bio-process Manufacturing Associate (Upstream)

Next Generation; Dublin; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Next Generation in Ireland seeks an Upstream Bioprocess Associate to support commercial manufacturing and the commissioning/qualification of process equipment in a large-scale biopharmaceutical facility.

Reporting to the Shift Lead, this role requires shift work as the site operates 24/7. You will execute manufacturing processes, maintain GMP documentation, and collaborate with cross-functional teams to ensure equipment readiness and continuous improvement.

Qualifikationen

• Minimum Level 6 qualification in Science or Engineering.
• At least three years’ experience in a large-scale biopharmaceutical manufacturing facility.
• Experience with GMP and controlled manufacturing documentation.
• Ability to work shifts in a 24/7 manufacturing environment.

Aufgaben

• Execute manufacturing processes and operate production equipment in accordance with GMP, SOPs and approved work instructions.
• Prepare and update operating procedures and manufacturing documentation.
• Use process automation, MES and data monitoring systems to support operations.
• Support batch record and exception report reviews with Quality Assurance.
• Contribute to investigations, troubleshooting and process improvements.
• Collaborate with Manufacturing, Engineering, Qualification, Automation and Validation teams to support equipment qualification and operational readiness.
• Promote safe working practices, continuous improvement and operational excellence.

Kenntnisse

Process control

Manufacturing execution

Data acquisition

GMP knowledge

Documentation

Problem-solving

Communication

Teamwork

Independent working

Shift work

Ausbildung

Level 6 qualification in Science or Engineering

Tools

Automation systems

Data monitoring systems

MES (Manufacturing Execution Systems)

Validation tools

Jobbeschreibung

We are seeking an Upstream Bioprocess Associate to support commercial manufacturing and the commissioning and qualification of process equipment within a large-scale biopharmaceutical facility.

Reporting to the Shift Lead, this position requires shift work as the site operates 24/7.

Key Responsibilities

• Execute manufacturing processes and operate production equipment in accordance with GMP, SOPs and approved work instructions.
• Prepare and update operating procedures and manufacturing documentation.
• Use process automation, manufacturing execution and data monitoring systems to support operations.
• Support batch record and exception report reviews with Quality Assurance.
• Contribute to investigations, troubleshooting and process improvements.
• Collaborate with Manufacturing, Engineering, Qualification, Automation and Validation teams to support equipment qualification and operational readiness.
• Promote safe working practices, continuous improvement and operational excellence.

Requirements

• Minimum Level 6 qualification in Science or Engineering, or relevant experience in a similar regulated industry.
• At least three years’ experience in a large-scale biopharmaceutical manufacturing facility.
• Experience with process control, manufacturing execution and data acquisition systems.
• Strong understanding of GMP and controlled manufacturing documentation.
• Good problem-solving, communication and teamwork skills.
• Ability to work independently, meet scheduled timelines and collaborate across functions.
• Availability to work shifts in a 24/7 manufacturing environment.