Position:Drug Product (DP) Engineer – Formulation- ContractLocation:Dundalk, IrelandRole OverviewWe are seeking aDrug Product Engineer – Formulationto provide technical leadership within a vaccine drug product manufacturing environment. The role focuses on ensuring safe, compliant, and efficient operation of equipment, supporting continuous improvement initiatives, and maintaining cGMP standards throughout the facility.Key ResponsibilitiesProvide technical guidance in the operation and maintenance of equipment within the Drug Product manufacturing suite.Ensure equipment and processes comply with cGMP regulations, industry standards, and internal engineering policies.Review, author, and execute testing protocols, SOPs, risk assessments, and manufacturing documentation.Manage equipment vendors, including maintenance visits, spare parts assessment, and continuous improvement projects.Support and lead equipment revalidation and maintenance of validated states according to site procedures.Collaborate in cross-functional teams to troubleshoot technical issues, optimize processes, and implement improvements using tools such as DMAIC and FMEA .Manage change control for equipment and processes, ensuring all modifications are documented and compliant.Lead or participate in equipment-related investigations, ensuring thorough root cause analysis and CAPA implementation.Identify process and equipment improvements and convert them into continuous improvement projects.Provide technical support for batch disposition and production ramp-up, addressing any mid-batch issues.Participate in TPM, CI, Gemba programs, and tiered manufacturing meetings.Provide technical expertise during regulatory inspections, supporting documentation and defending engineering practices.RequirementsMinimum 5 years of experience in cGMP industrial or engineering environments .Hands-on experience with FAT, SAT, IQ/OQ execution.Strong analytical skills with experience in root cause analysis and data-driven continuous improvement initiatives (e.g., Six Sigma).Experience leading and resolving complex technical investigations.Risk-based manufacturing experience using tools such as FMEA .Ability to adapt to changing priorities in a fast-paced environment.EducationBachelor's degree in Engineering, Science, or a technology-related discipline .Preferred Skills & ExperiencePractical experience with autoclaves, parts washers, CIP/SIP systems .Knowledge of formulation processes and drug product manufacturing.Experience in start-up facilities and CQV activities.Familiarity with regulatory standards, e.g., Annex 1.Strong technical writing, communication, planning, and organizational skills.