Process Engineer in Pre-Filled Syringe Manufacturing

Location: Waterford, Ireland; on-site

Salary: €54,800–€73,067 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines, including commercial monoclonal antibody products.

What you will do

• Provide engineering support for business-as-usual operations and continuous improvement within pre-filled syringe manufacturing.
• Own batch release activities for fill operations, including investigations, root cause analysis, CAPA generation and closure, work order investigations, and batch comment resolution.
• Support continuous improvement, new product introduction, and capacity expansion across thawing, formulation, filling, filter integrity testing, and wash/autoclave operations.
• Execute cycle development, protocol generation and execution, project improvements, deviation management, problem solving, and change controls.
• Support the aseptic syringe filling line and equipment, including debagging, E-beam, delidding, deline, isolator, and multiple filling technologies.
• Deliver key performance metrics supporting commercial manufacturing.

Requirements

• Degree in an engineering discipline.
• Relevant experience in a highly regulated GMP environment.
• Experience in sterile manufacturing operations.
• Strong problem-solving, documentation, protocol generation, and protocol execution skills.
• Ability to work on-site in Waterford, Ireland.

Nice to have

• Batch release experience.
• Experience with root cause analysis and investigations.
• Experience in syringe or vial filling and inspection.

Culture & Benefits

• Work on medicine and vaccine delivery technology in a sterile manufacturing environment.
• Contribute to more than 30 planned product launches by 2030.
• Opportunities to develop new skills and explore cross-functional roles.
• Eligibility for company employee benefit programs.
• 23-month fixed-term contract with a standard-day schedule.