Process Engineer

Job Description• The candidate will be responsible for supporting small and large molecule drug product manufacturing at a leading biopharmaceutical site in Dublin. As part of the global Process Development organization, they will play a key role in ensuring the highest standards of process performance while providing process and product support to inspected drug product operations.• Independently perform design and qualification activities.• Act as author and/or reviewer for protocols, reports, and technical assessments.• Support make-a-batch exercises to determine facility fit and identify gaps in the visual inspection process.• Support new product introductions (NPIs) with visual inspection method development and AVI characterization for new inspection lines.• Provide expertise on defects identified during batch inspection and support defect library updates.• Contribute to the development of visual inspection team members, enabling new colleagues to shadow and learn inspection processes.• Support the characterization and qualification of AVI vision recipes as part of process improvements.• Provide technical support for manufacturing and commercial activities.• Lead or assist in process-related deviations, exception resolution, and root cause analysis to ensure smooth operations and continued supply. Assist in troubleshooting issues with drug product processing technologies and equipment.• Maintain audit readiness and provide support during GMP audits.Basic Qualifications• Bachelor’s degree in Science, Engineering, or a relevant discipline with 2–3 years’ experience in a similar role, or• Master’s degree with 2 years of directly related experience.• Experience in a regulated and/or vision-related work environment.Preferred Qualifications• 3+ years of drug product process development experience in the pharmaceutical or biotechnology industry.• Knowledge or hands-on experience with end-to-end development for liquid and lyophilized drug products across various presentations.• Interest in working in a collaborative, problem-solving environment, providing solutions to operational inspection challenges.• Independent thinker with proven ability to work effectively in teams.• Strong interpersonal and communication skills.• Demonstrated problem-solving ability and a genuine interest in identifying root causes and continuous improvement.