Senior Biopharma Process Design Engineer

Tandem Project Management Ltd.; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Tandem Project Management Ltd. is assisting a biopharmaceutical client in Dublin in finding a Senior Process Design Engineer to support Drug Substance manufacturing processes.

You will be part of the site Process Engineering team handling technical aspects of manufacturing and key deliverables. The role requires 8–12+ years in a regulated setting, strong GMP/GxP knowledge, and experience leading cross-functional teams.

Qualifications

• Bachelor’s or Master’s degree in Chemical or Process Engineering.
• 8–12+ years in engineering, capital projects, or technical operations in regulated industries.
• Strong GMP/GxP knowledge and validation practices (IQ/OQ/PQ).
• Chartership or PE/CEng preferred.
• Experience leading cross-functional technical teams.

Responsibilities

• Provide technical input on New Product Introductions into the Manufacturing Facility.
• Support all phases of the product lifecycle including tech transfer, scale-up, validation, and routine manufacturing.
• Collaborate with operations, QA, QC, analytical sciences, regulatory, and supply chain groups.
• Collect, organize, trend GMP manufacturing data and perform analysis.
• Support major technical investigations across the manufacturing network.
• Lead troubleshooting and improvements with site partners to optimize processes.
• Identify, scope, and deliver capacity improvements to meet takt and changeover targets.

Skills

GMP/GxP knowledge

Regulatory compliance

Validation IQ/OQ/PQ

Cross-functional leadership

C&Q knowledge

Change management

Education

Bachelor’s or Master’s degree in Chemical/Process Engineering

Professional Engineering Accreditation or Chartership (CEng/PE) – preferred

Job description

Tandem Project Management Ltd. is assisting a biopharmaceutical client in Dublin in finding a Senior Process Design Engineer to support Drug Substance manufacturing processes.

You will be part of the site Process Engineering team handling technical aspects of manufacturing and key deliverables. The role requires 8–12+ years in a regulated setting, strong GMP/GxP knowledge, and experience leading cross-functional teams.