Project Engineer - Aseptic Filling Line

Fastnet; Munster; On-site; EUR 80,000 - 110,000; Full time

Job summary

Fastnet is seeking an experienced Project Engineer to support a new sterile fill-finish facility. You will act as a technical SME for aseptic filling equipment, overseeing installation, commissioning and qualification to achieve operational readiness.

You will collaborate with vendors and internal teams to resolve technical issues and ensure GMP and EU Annex 1 compliance throughout project execution.

Qualifications

• 5+ years in pharmaceutical engineering
• Experience with sterile/aseptic filling lines
• GMP environment experience

Responsibilities

• Act as SME for aseptic filling lines and provide technical expertise throughout project execution.
• Support equipment installation, commissioning, qualification and start-up activities.
• Liaise with equipment vendors and cross-functional teams to resolve technical issues.
• Ensure filling equipment and processes comply with GMP and EU Annex 1 requirements.

Skills

Aseptic filling

Project engineering

GMP compliance

Vendor liaison

Troubleshooting

Education

Engineering degree

Job description

An exciting opportunity for an experienced Project Engineer to support a new sterile pharmaceutical fill-finish facility. The successful candidate will act as a technical Subject Matter Expert (SME) for aseptic filling equipment, supporting equipment installation, qualification and operational readiness.

Key Responsibilities:

• Act as SME for aseptic filling lines, providing technical expertise throughout project execution.
• Support equipment installation, commissioning, qualification and start-up activities.
• Liaise with equipment vendors and cross-functional teams to resolve technical issues.
• Ensure filling equipment and processes comply with GMP and EU Annex 1 requirements.

Key Requirements:

• Degree in Mechanical, Process, Chemical Engineering or a related discipline.
• 5+ years' pharmaceutical engineering experience, with strong hands-on knowledge of sterile/aseptic filling lines.
• Experience with filling equipment commissioning, qualification and troubleshooting in a GMP environment.