padraig cullinan

* Responsible for transfer of Polystyrene Milling Media purification process from US plant to Athlone for manufacturing. * Adapt existing building & equipment to suit new processes. * Process installation and development through engineering trials. * Develop timelines for process operation and additional activities. * Carry out process investigations to establish the cause of process deviations and implement solutions. * Gather process data and interpretation of results. * Develop batch records, validation protocols, SOPs, risk assessments, engineering reports and sampling methods.

* Conduct commissioning and qualification of new automated GMP facility. * Oversee process and equipment transfer from existing site to new production suites. * Responsible for engineering trials on equipment and processes. * Provide official process transfer to production and follow-up support as well as training to process operators. * Participate in process and safety risk assessments. * Conduct temperature mapping on steam autoclaves and ovens. * Update P&IDs on AutoCad.

* Responsible for new product and equipment introduction. * Carry out process investigations and implement solutions and upgrades. * Lead engineer installation, commissioning and validation of filter dryer. * Department representative for HAZOP analysis. * 5s Engineering department leader.

Responsible for new product and materials introduction to production lines Investigate out of specification products. Develop Process Capabilities and analyse CpK and PpK measurements Write, review and execute procedures and test plans. Preparation of processes and documentation for FDA & BSI audits.

* Subject Matter Expert (SME) for all engineering activities within one of the sites manufacturing plants. * Project Manager for onsite capital expenditure projects. * Client engineer for new products into plant. Adapt existing equipment to accommodate new process. * Develop and implement process commissioning and validation documents. * Responsible for process safety within the 05 manufacturing plant. Contribute to HAZOPs, LOPAs, develop Basis of Safety and K1 (Process Industrial Hygiene) documents and Safety Risk Assessments. * Identify key process parameters and develop systems to monitor these on a regular basis. * Lead Investigator for safety incidents and quality issues. * Always looking for ways to improve process safety, efficiency and reduce downtime. * Responsible for pipe and equipment modifications and process setups. * Contribute to on-site audits including FDA, HSA and corporate audits.