Sr. Engineer Process Development

Location: Dun Laoghaire, Ireland; onsite at hirify.global Dun Laoghaire.

Salary: €70,408.90–€95,259.10 per year.

Company

hirify.global develops and manufactures large-molecule and small-molecule medicines in a regulated biopharmaceutical environment.

What you will do

• Lead filling process characterization, including recipe development, protocol design, execution, statistical analysis, result interpretation, and technical reporting.
• Provide scientific and engineering support for aseptic drug product manufacturing, syringe filling operations, formulation, and single-use technologies.
• Lead qualification, implementation, and lifecycle management of filling technologies and manufacturing systems.
• Support technology transfer, process validation, commercial manufacturing, and site expansion activities for new syringe filling lines.
• Troubleshoot process, equipment, and product performance issues using structured, data-driven root-cause methodologies.
• Lead investigations, deviation management, risk assessments, CAPA development, continuous improvement, and cross-functional technical decision-making.

Requirements

• Bachelor’s degree in Science, Engineering, Quality, or a related discipline with 7 years of directly related experience; alternatively, a Master’s degree with 5 years or an Associate’s degree with 12 years of experience.
• Knowledge of cGMP and applicable global regulatory requirements, including FDA and EU expectations.
• Strong understanding of aseptic manufacturing technologies, filling operations, formulation, single-use systems, and process design.
• Experience working in cross-functional teams within a highly regulated manufacturing environment.
• Strong problem-solving, written, verbal, technical communication, stakeholder management, and influencing skills.
• Ability to lead technical discussions, influence without authority, and mentor engineers and scientists.

Nice to have

• PhD or Master’s degree in Science or Engineering.
• Experience with commercial sterile drug product manufacturing, process characterization, technology transfer, validation, or process development.
• Experience with peristaltic pump filling systems, filtration, and protein-based drug product manufacturing.
• Expertise in deviation investigations, CAPA development, risk management, and quality systems.
• Experience presenting technical information to leadership teams, regulatory agencies, governance forums, or external stakeholders.

Culture & Benefits

• Work within a highly regulated manufacturing organization focused on safety, quality, compliance, and operational excellence.
• Collaborate with Manufacturing, Operations, Engineering, Quality, Validation, Supply Chain, Regulatory Affairs, global subject matter experts, and external vendors.
• Participate in global cross-functional teams, technical communities of practice, and network harmonization initiatives.
• Support capability development through mentoring, coaching, knowledge transfer, and organizational development activities.