GMP Manufacturing Process Specialist – IPT & Equipment

Johnson Johnson; Cork; On-site; EUR 78,000 - 105,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Cork, Ireland, seeks a Manufacturing Process Specialist to optimise biomanufacturing processes and support IPT equipment across manufacturing suites. The role involves first-line troubleshooting, cGMP compliance, and collaboration with cross-functional teams on capital projects.

The candidate will lead commissioning/qualification activities, maintain documentation, and mentor new recruits within a dynamic manufacturing environment.

Qualifications

• Bachelor’s degree in a relevant science or engineering field.
• GMP-regulated manufacturing experience.
• Experience with cell culture or purification processes.
• Process engineering experience.
• Commissioning/qualification experience is desirable.
• Proficiency with MS Office and SCADA/DCS systems is desirable.
• Experience with SAP/LIMS is desirable.
• Six Sigma or similar problem-solving training is desirable.
• Teamwork and attention to detail are essential.

Responsibilities

• Manage IPT equipment uptime and troubleshoot reliability issues.
• Coordinate vendor PM and calibration of IPT equipment.
• Represent Operations on cross-functional project teams.
• Monitor and optimize process performance using SPC.
• Troubleshoot DCS (DeltaV), SCADA, and PLC systems.
• Prepare and update Batch Records, Procedures, and Work Instructions.
• Provide process/equipment training within Manufacturing.
• Support cGMP/EHS compliant manufacturing and documentation.
• Lead commissioning/qualification activities and support validation.

Skills

Manufacturing

GMP knowledge

Cell culture experience

Process engineering

Teamwork

Attention to detail

Problem solving

Education

Bachelor’s degree in Microbiology / Biochemistry / Pharmacy / Biotechnology / Science / Engineering

Tools

DCS (DeltaV)

SCADA

PLC systems

SAP

LIMS

MS Word/Excel/Outlook

Job description

Johnson & Johnson Innovative Medicine in Cork, Ireland, seeks a Manufacturing Process Specialist to optimise biomanufacturing processes and support IPT equipment across manufacturing suites. The role involves first-line troubleshooting, cGMP compliance, and collaboration with cross-functional teams on capital projects.

The candidate will lead commissioning/qualification activities, maintain documentation, and mentor new recruits within a dynamic manufacturing environment.