Lead Equipment Engineer – Aseptic Fill-Finish Systems

Ascend Project Management, Inc.; Dublin; Hybrid; EUR 55,000 - 75,000; Part time

Job summary

Ascend Project Management, Inc. is recruiting an experienced Equipment Engineer for a leading pharmaceutical manufacturer in South Dublin on a 12-month contract with three onsite days per week.

The role focuses on implementing, qualifying, and delivering high-speed syringe filling systems and single-use technologies within a GMP environment. You will lead design-to-commissioning activities, ensure readiness for manufacturing, and maintain lifecycle plans while aligning with regulatory standards

Qualifications

• Degree in Mechanical, Electrical, Chemical, or related Engineering discipline.
• 5+ years’ experience in biopharmaceutical manufacturing or equipment engineering.
• Experience with aseptic fill-finish systems, ideally high-speed syringe filling lines.
• Strong understanding of GMP, Annex 1, aseptic processing principles, and equipment validation lifecycle.

Responsibilities

• Act as equipment system owner throughout design, installation, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and validation lifecycle.
• Lead equipment readiness activities and support smooth handover to manufacturing operations.
• Ensure compliance with GMP, Annex 1, regulatory requirements, and global quality standards.
• Develop and maintain maintenance strategies, preventive maintenance programs, critical spare parts lists, and lifecycle asset plans.
• Provide technical leadership for deviation investigations, troubleshooting, and equipment performance optimisation.
• Collaborate cross-functionally with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering.
• Support new product introduction (NPI) and technology transfer activities.

Skills

Equipment engineering

GMP knowledge

Project leadership

Troubleshooting

Regulatory compliance

Education

Engineering degree (Mechanical/Electrical/Chemical)

Tools

IQ/OQ/PQ lifecycle

Job description

Ascend Project Management, Inc. is recruiting an experienced Equipment Engineer for a leading pharmaceutical manufacturer in South Dublin on a 12-month contract with three onsite days per week.

The role focuses on implementing, qualifying, and delivering high-speed syringe filling systems and single-use technologies within a GMP environment. You will lead design-to-commissioning activities, ensure readiness for manufacturing, and maintain lifecycle plans while aligning with regulatory standards