Principal Engineer, Process Development NPD (Drug Products)

Location: Castlebar, Mayo, Ireland; approximately 20% business travel to manufacturing plants, suppliers, laboratories, and other R&D locations.

Company

hirify.global develops vital organ therapy products and services, with a focus on kidney care, dialysis, digital solutions, and advanced therapies.

What you will do

• Lead process-development planning and execution for new product development from feasibility through production readiness.
• Translate product requirements and critical quality attributes into manufacturing requirements, operating parameters, controls, specifications, and validation plans.
• Plan process evaluations, development builds, process characterization, scale-up, and manufacturability assessments at receiving manufacturing sites.
• Act as the technical liaison between R&D and Manufacturing, transferring process knowledge and closing gaps in equipment, tooling, documentation, materials, and readiness.
• Lead or support investigations into process issues, product defects, qualification, validation, and early production problems using structured, data-based problem solving.
• Support change control, nonconformance, CAPA, product-impact assessment, regulatory, audit, and inspection activities.

Requirements

• Bachelor’s or master’s degree in chemical, mechanical, manufacturing, biomedical, pharmaceutical engineering, or a related discipline; a master’s degree is preferred.
• At least 7 years of relevant industrial experience in R&D process development, manufacturing engineering, drug solution manufacturing, or sustaining engineering in a regulated industry.
• Experience designing, developing, and implementing manufacturing processes for new products or significant product changes.
• Experience transferring products and process knowledge from R&D to Manufacturing or between manufacturing sites, including engineering builds, qualification, validation, and launch readiness.
• Working knowledge of design controls, risk management, change control, process validation, technical documentation, and Good Documentation Practices.
• Ability to collaborate across R&D, Manufacturing, Quality, Engineering, and Product Development while managing priorities and driving actions to completion.

Nice to have

• Experience in pharmaceutical, medical device, combination-product, or other highly regulated manufacturing environments.
• Knowledge of polymer extrusion, molding, welding, forming, assembly, bag making, filling, packaging, or automated inspection.
• Familiarity with process characterization, design of experiments, statistical analysis, process capability, equipment qualification, and FDA, EU, ISO, ICH, or cGxP expectations.

Culture & Benefits

• Work within the Drug Products R&D organization supporting vital organ therapies and patient care.
• Collaborate with R&D, Manufacturing, Engineering, Quality, suppliers, laboratories, and other development locations.
• Participate in approximately 20% business travel to support manufacturing and development activities.
• Reasonable accommodations are available during the application and interview process.