Summary:Our client, a leading biopharmaceutical company located in Louth, is seeking aDP Engineer – Formulationto provide technical leadership within a new Drug Product manufacturing facility. The successful candidate will support the introduction, operation and optimisation of formulation equipment and processes, ensuring all systems are safe, compliant and operating in line with industry standards. The role involves equipment readiness, troubleshooting, continuous improvement, change management, and maintaining the validated state of all relevant systems.Responsibilities:Provide technical leadership for formulation equipment and processes within the Drug Product manufacturing area.Ensure all equipment installed is safe, effective and compliant with applicable standards and engineering procedures.Support the development, review and execution of testing protocols, reports and manufacturing documentation.Prepare and execute cGMP documentation, including risk assessments and associated reports.Manage equipment vendors, including oversight of maintenance activities, continuous improvement projects and spare part criticality assessments.Maintain validated equipment status by executing revalidation protocols in alignment with the site Validation Master Plan.Troubleshoot equipment and process issues, collaborating with cross-functional teams to implement effective corrective and preventive actions.Apply structured problem-solving and continuous improvement tools such as DMAIC and FMEA to drive operational excellence.Manage equipment or process changes through the site change control system.Contribute to establishing a new Preventive Maintenance (PM) programme for Drug Product equipment.Lead and support technical investigations, ensuring root cause analysis, impact assessment and appropriate CAPA implementation.Identify opportunities for process and equipment optimisation and translate these into CI initiatives.Support batch disposition by resolving technical or engineering issues encountered during processing.Participate in TPM, CI and Gemba activities, and engage in daily and weekly tiered manufacturing meetings.Provide technical support during regulatory inspections, defending systems, investigations, validations and change controls as needed.Assist in the transition from project start-up to sustained manufacturing operations, supporting scale-up and long-term equipment reliability.Qualifications & Experience:Bachelor's degree in Engineering, Science or a related technical discipline.Minimum 5 years' engineering experience in a cGMP manufacturing environment.Experience executing FAT, SAT, IQ and OQ in an operational setting.Strong background in structured problem solving and CI methodologies (e.g., Six Sigma).Demonstrated experience resolving complex technical investigations.Knowledge and application of risk-based tools such as FMEA.Experience with autoclaves, parts washers and CIP/SIP systems.Knowledge of formulation processes and associated equipment.Experience working in start-up facilities is an advantage.CQV experience is desirable.Familiarity with regulatory frameworks such as Annex 1 is beneficial.