<p>Job Title</p> <p>Senior Process Engineer</p> <p>Requisition</p> <p>JR000015734 Senior Process Engineer (Open)</p> <p>Location</p> <p>College Park, Dublin - IRL006</p> <p>Additional Locations</p> <p>Job Description Summary</p> <p>Reporting to the Engineering Services Lead, the Senior Process & Project Engineer is responsible for leading and executing multi-discipline capital projects and managing the lifecycle of process systems and critical utilities at the Dublin site. This role ensures projects are delivered on time, within scope, budget, and in compliance with cGMP requirements, while driving continuous improvement and operational efficiency. The role also provides global engineering support, sharing best practices and technical expertise across the organization's network.</p> <p>Job Description</p> <p>Roles and Responsibilities</p> <ol> <li>Project Leadership & Execution </li></ol> <ul> <li>Plan, manage, and execute multi-discipline capital projects from concept through commissioning and qualification. </li><li>Ensure projects meet defined scope, schedule, budget, and cGMP compliance requirements. </li><li>Lead cross-functional project teams, coordinating internal stakeholders, vendors, and contractors. </li><li>Develop project charters, assess risks, and implement mitigation strategies to ensure successful outcomes. </li><li>Participate in design reviews, equipment selection, P&ID evaluations, and validation activities. </li></ul> <ol start="2"> <li>Validation, Compliance & Documentation </li></ol> <ul> <li>Generate, review, and execute cGMP-compliant documentation for system validation, requalification, and periodic review (IQ/OQ/PQ/QV protocols, validation plans, risk assessments, and reports). </li><li>Maintain process equipment and systems in a validated state throughout their lifecycle. </li><li>Support regulatory inspections, providing documentation and technical expertise as required. </li></ul> <ol start="3"> <li>Process Engineering & Operational Support </li></ol> <ul> <li>Provide process and project engineering support across all phases of the product lifecycle, including facility design, technology transfer, process validation, and commercial manufacturing. </li><li>Troubleshoot process equipment and clean utilities to support manufacturing during deviations, transfers, or operational challenges. </li><li>Identify and implement process optimisation initiatives to improve efficiency, capacity, and reliability. </li><li>Support Manufacturing, Validation, and Maintenance teams with technical guidance and operational problem-solving. </li></ul> <ol start="4"> <li>Continuous Improvement & Best Practices </li></ol> <ul> <li>Identify, develop, and implement best practices for process systems, manufacturing, and utilities. </li><li>Participate in continuous improvement initiatives to enhance operational performance and compliance. </li><li>Drive engineering contributions to site-wide and global initiatives. </li></ul> <ol start="5"> <li>Global Responsibility </li></ol> <ul> <li>Serve as the site's engineering liaison for global process and capital projects. </li><li>Collaborate with engineering, operations, and quality teams across the global network to share best practices, resolve technical issues, and standardize approaches. </li><li>Participate in global task forces or working groups to troubleshoot complex issues and implement improvements. </li><li>Integrate learnings from global initiatives into site operations to enhance efficiency, reliability, and compliance. </li></ul> <ol start="6"> <li>Finance / Capital Budget Management </li></ol> <ul> <li>Own and manage the financial aspects of assigned capital projects, including budgeting, forecasting, and cost tracking. </li><li>Collaborate with site finance and project stakeholders to ensure projects are delivered within approved budgets. </li><li>Identify cost-saving opportunities while maintaining compliance, quality, and project scope. </li><li>Provide regular financial updates to site leadership on capital project expenditure and variances. </li><li>Support business case development for new capital investments, including cost-benefit analysis and ROI evaluation </li></ul> <ol start="7"> <li>Knowledge Sharing & Technical Training </li></ol> <ul> <li>Provide technical training and mentorship to operations and engineering teams on process equipment, systems, and best practices. </li><li>Ensure smooth transition from project to operational phases, supporting operations with technical guidance. </li></ul> <p>Experience, Qualifications and Education Requirements</p> <ul> <li> <p>Third level degree in Process Engineering, Chemical Engineering, Mechanical Engineering, or related discipline</p> </li><li> <p>7+ years of relevant industry experience, preferably in biopharmaceutical, pharmaceutical, or highly regulated manufacturing environments.</p> </li><li> <p>Proven experience in leading multi-disciplined capital projects, from concept through commissioning and qualification.</p> </li><li> <p>Solid understanding and hands-on experience with cGMP, FDA, HPRA, or equivalent regulatory standards for process systems and critical utilities.</p> </li><li> <p>Experience with process validation, equipment qualification, and lifecycle management of manufacturing systems.</p> </li><li> <p>Demonstrated ability to manage budgets, financial tracking, and cost optimisation for capital projects.</p> </li><li> <p>Strong track record in continuous improvement initiatives, operational efficiency projects, and technical problem-solving.</p> </li><li> <p>Self-motivated, organised, and able to prioritise and manage multiple projects simultaneously.</p> </li><li> <p>Excellent technical writing and documentation skills, including preparation of validation protocols, risk assessments, and project reports.</p> </li></ul> <p>Competencies / Preferred Skills</p> <ul> <li> <p>Project Leadership & Execution: Ability to lead cross-functional teams, manage project schedules, and drive projects to successful completion.</p> </li><li> <p>Technical Expertise: Deep knowledge of process systems, utilities, equipment design, and manufacturing operations.</p> </li><li> <p>Regulatory & Compliance Focus: Strong understanding of cGMP and regulatory expectations for validation, qualification, and documentation.</p> </li><li> <p>Analytical & Problem-Solving Skills: Ability to troubleshoot complex technical issues and implement practical, effective solutions.</p> </li><li> <p>Continuous Improvement Mindset: Experience identifying and implementing process optimisation initiatives and operational improvements.</p> </li><li> <p>Collaboration & Communication: Strong interpersonal skills to engage with teams globally, share best practices, and provide mentorship.</p> </li><li> <p>Attention to Detail: Rigorous approach to documentation, validation, and process safety.</p> </li><li> <p>Adaptability & Initiative: Able to work independently, anticipate challenges, and drive solutions proactively.</p> </li><li> <p>Preferred Technical Skills: Familiarity with P&ID design, CAD software, process simulation tools, and project management software is advantageous.</p> </li><li> <p>Global Perspective: Ability to work within a global network, standardise practices, and contribute to cross-site initiatives.</p> </li></ul> <p>At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.</p> <p>We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.</p> <p>We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.</p>