KPC International in Munster, Ireland is seeking an Equipment Project Engineer to manage biopharmaceutical projects worth millions. You will handle scheduling, planning, and resource management while ensuring compliance with safety and quality standards. The ideal candidate should have a degree in Mechanical or similar engineering, at least 10 years of project management experience, and automation knowledge. Join us to deliver impactful products to patients while working in a collaborative team environment. #J-18808-Ljbffr
KPC International - Excellence from Concept to Completion KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space. We specialise in Plant Facility Start-Up, from Strategy and Planning through to Execution and Operational Readiness. We are proud to support our clients in delivering their life‑changing products to patients. CSV Engineer We are seeking a Computer System Validation (CSV) Engineer to support validation activities across pharmaceutical manufacturing and laboratory systems, ensuring compliance with GMP, GAMP 5, Annex 11, and 21 CFR Part 11 requirements. Key Responsibilities Execute CSV lifecycle activities, including URS, risk assessments, IQ/OQ/PQ, traceability, and validation reports Ensure compliance with data integrity, GMP, and regulatory standards Support FAT, SAT, commissioning, and qualification of automated systems Manage change controls, deviations, and CAPAs for validated systems Collaborate with Engineering, QA, Automation, Production, and Vendors Support audits and inspections with complete validation documentation Systems in Scope Production Autoclave, Parts Washer, Lab Autoclave, Lab Isolator Filling Line Isolators (4 systems), including VHP and HVAC integration Filling Machine with CIP/SIP, Capping Machine, External Washer, Tray Loader Requirements Degree in Engineering, Life Sciences, Automation, or related field 3+ years’ experience in CSV/CQV within pharma, biotech, or medical devices Experience validating automated equipment and control systems Strong knowledge of GMP, GAMP 5, and regulatory validation requirements Experience with aseptic/filling or isolator‑based systems is highly desirable Skills Strong documentation and validation protocol writing Risk‑based validation approach Cross‑functional collaboration Strong attention to detail and compliance mindset KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC – International is an Equal Opportunity Employer. #J-18808-Ljbffr
KPC International - Excellence from Concept to Completion KPC International began operations in 2001; our team of Engineers and scientists has helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space. We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients. Equipment Project Engineer Equipment Project Engineer to work within biopharmaceutical operations, which include enzyme, (mAbs), oral dosage, medical device, laboratories & packaging operations. The successful candidate will schedule, plan, forecast, resource and manage all activities to ensure the project schedule, cost, quality and scope adherence are maintained from conception to completion. The assigned projects will be for a multi-million-euro portfolio. Key Responsibilities Deliver multiple automation-related projects, primarily virtualisation of servers associated with live production equipment. Deployment will occur in defined shutdowns requiring excellent coordination. Management of multiple groups, Global & local ITS teams, Automation, Validation and Production teams, along with specialist external contractors. Develop solutions along with the Original Equipment Manufacturer (OEM) to upgrade control systems. Provide automation support and expertise in the procurement, build, commissioning and qualification of GMP equipment. Working in a team environment on several projects deployed in a phased manner. Deliver on packaging, serialisation & aggregation biopharmaceutical equipment project portfolio within our biopharmaceutical operations, which include enzyme, (mAbs), oral dosage, medical device, laboratories & packaging operations. Perform procurement, acceptance of equipment & associated infrastructure and report regularly on project status throughout the project lifecycle. Management of the end-to-end project lifecycle is key to success. Ensure compliance with environmental, health and safety codes, practices, approved project KPIs, performance standards and specifications are maintained. Liaise with external and internal customers, suppliers, and vendors to define and deliver the right first-time project deployment. Chair and interact with assigned project teams to interpret their requirements and ensure approval to align project scope as requested. Assign responsibilities, mentor the project team and maintain accurate project planning documentation. Communicate effectively with weekly reports to management and senior stakeholders. Support to other project participants to overcome obstacles when they present themselves. Review engineering deliverables, initiate site change controls and associate documentation required by the project life cycle. Responsible for delivering performance metrics for budget, schedule, scope and quality adherence. Essential Skills and Experience Degree in Mechanical, Chemical, Industrial or equivalent Engineering discipline. Minimum 10+ years’ experience in a project management role. Detailed knowledge of the cGMP pharmaceutical environment with strong automation experience. Exemplary communication, dedication and keen focus on delivering the key to success within the role. Master's is an advantage. KPC – International is an Equal Opportunity Employer. #J-18808-Ljbffr
KPC International - Excellence from Concept to Completion KPC International began operations in 2001; our team of Engineers and scientists has helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space. We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients. Project Engineer - Product Portfolio Management We are seeking a Project Engineer - Product Portfolio Management to support project delivery and gain hands-on experience in biopharma project management. This role offers strong development opportunities within a fast-paced, regulated environment, working closely with experienced Project Managers. KEY RESPONSIBILITIES Project Coordination Support Project Managers on cross-functional, multi-site projects (including Dupixent DS integration and other site initiatives) Assist with scope definition, requirements gathering, and documentation Maintain project schedules, milestones, and progress tracking Coordinate meetings, agendas, minutes, and action tracking Support stakeholder communication across sites Assist with risk tracking, mitigation actions, and budget monitoring Maintain project documentation Lead smaller projects under PM guidance Change Control Raise, manage, and track change controls in line with GMP and Quality Systems Coordinate cross-functional execution to ensure timely completion Ensure compliance with regulatory and GMP requirementsSupport post-implementation reviews and effectiveness checks Maintain GMP documentation (training provided) Planning & Scheduling Develop and maintain project schedules using MS Project/Excel Track milestones, dependencies, and deliverables Support resource planning and conflict identification Assist in timeline development and project planning activities ESSENTIAL SKILLS AND EXPERIENCE Degree in Engineering, Science, or related field (graduates welcome) Interest in project management and willingness to develop PM skills Some pharma/biopharma exposure is beneficial but not essential Strong organisation and attention to detail Basic knowledge of project tools (MS Project, Excel) desirable Understanding of GMP/regulated environments an advantage Strong communication and teamwork skills Proactive, self-motivated, and able to manage small projects independently Eager to learn and develop in a dynamic environment KPC - International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC - International is an Equal Opportunity Employer. #J-18808-Ljbffr
KPC International - Excellence from Concept to Completion KPC International began operations in 2001; our team of Engineers and scientists has helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space. We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients. Process Engineer Reporting to the Product Supply Team Lead, you will play an integral role within the Product Supply Unit’s team, ensuring a reliable supply of syringes and vial products to our patients globally. KEY RESPONSIBILITIES Provide process engineering support to the Product Supply APU. Support delivery of continuous improvement projects to existing equipment. Work closely with various departments, such as MSAT, Technical Development, Quality Assurance, and Supply Chain. Utilisation of knowledge gained from existing manufacturing technologies to aid in the development of new technologies to implement higher output and yield. Ensure safety compliance, providing technical and engineering support for process and equipment failures, identifying and implementing process and product improvements, supporting qualification of new products/processes, analysing machine performance data, and managing improvement projects within budget and time constraints. Support new product introductions and capacity expansions, including new vendor selections, maintenance planning, design changes, change controls, OEE improvement, yield improvement, etc. Lead systematic technical root cause investigations. Support all company safety and quality programs and initiatives. ESSENTIAL SKILLS AND EXPERIENCE Experience in a highly regulated GMP environment. Degree in an Engineering discipline. Strong problem-solving and communication skills. Strong documentation/protocol generation and execution skills. Strong data analysis experience with equipment and integrated systems is desirable. KPC International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC – International is an Equal Opportunity Employer. #J-18808-Ljbffr
KPC International, located in Munster, Ireland, is looking for a Project Engineer in Product Portfolio Management. The ideal candidate will have a degree in Engineering or Science and should be proactive, eager to learn, and possess strong communication and organizational skills. Key responsibilities include supporting project managers, developing project schedules, and maintaining thorough documentation within a GMP-regulated environment. This position provides strong development opportunities and an inclusive workplace culture. #J-18808-Ljbffr
KPC International is seeking a Process Engineer in Munster, Ireland, to provide essential process engineering support within the Product Supply Unit. The role involves ensuring reliable supply of syringes and vials globally while adhering to safety and quality standards. Candidates should have a degree in Engineering and experience in regulated GMP environments. Strong problem-solving and communication skills are essential. KPC International promotes an inclusive workplace with a focus on employee development. #J-18808-Ljbffr
KPC International - Excellence from Concept to Completion KPC International began operations in 2001. Our team of Engineers and scientists has helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space. We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients. At KPC International , we’re looking for a talented Cost Engineer to join our high-performing team. This is a unique opportunity to work at the intersection of project delivery, cost control, and commercial strategy , partnering directly with senior leadership on complex, high-value life sciences projects. RESPONSIBILITIES Track and manage costs across labour, materials, and subcontractors while developing forecasts, variance analyses, and detailed cost reports. Work closely with engineering and CQV teams to ensure that reported costs accurately reflect project progress and proactively identify risks while implementing effective cost mitigation strategies. Support the development of both fixed-price and reimbursable bids by building detailed cost models across CQV, CSV, Utilities, HVAC, and Process disciplines. Use historical data to strengthen pricing accuracy and competitiveness, while contributing to overall margin strategy and key commercial assumptions. Develop and maintain internal rate cards, ensuring they remain aligned with current market trends and contractor rates. Provide informed insights on pricing strategy, considering talent availability and broader market dynamics. Deliver clear and concise insights on cost performance, margins, and forecasts, while continuously improving cost tracking tools such as Excel, Smartsheet, and Power BI. Drive standardisation in reporting processes and support stronger integration across teams. SKILLS AND EXPERIENCE 5–10+ years’ experience in Cost Engineering, Project Controls, or Commercial roles Experience in pharma/biotech/life sciences (highly desirable) Strong understanding of engineering project lifecycles (design → CQV → handover) Proven experience supporting fixed-price bids and cost models Advanced Excel (essential) Cost modelling, forecasting & variance analysis Strong commercial acumen and strategic thinking Confidence to challenge assumptions and influence decisions KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC – International is an Equal Opportunity Employer. #J-18808-Ljbffr
A leading life sciences consultancy in Ireland is seeking a talented Cost Engineer to join their team. You will be responsible for tracking and managing costs across various projects, supporting fixed-price bids, and delivering insights on cost performance. The ideal candidate should have 5–10+ years of experience in Cost Engineering with a strong understanding of project lifecycles, especially within the pharma sector. This position offers an inclusive environment and growth opportunities. #J-18808-Ljbffr
KPC International - Excellence from Concept to Completion KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space. We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients. KEY REQUIREMENTS Leading the transition from LUNA, QC Testing for Environmental monitoring, Raw materials, Product Testing, Stability Studies and CoA plus paper processes to One LIMS (Laboratory Information Management System). 1LIMS is a cloud-based LIMS software. Develop comprehensive project plans, setting clear objectives, and overseeing the end-to-end execution of digital projects, ensuring they are completed on time and within budget. Efficiently allocate resources, including budgets, personnel, and technology assets, to maximise project outcomes and minimise wastage. Build and maintain strong relationships with stakeholders at all levels of the organisation, including senior management, cross-functional teams, and external partners, to ensure alignment and collaboration. Identify potential risks and obstacles that could impede project progress and develop strategies to mitigate them. Ensure that the digital solutions and technologies implemented meet predefined quality standards and performance benchmarks. Manage the organisational and cultural shifts that often accompany digital implementations, helping employees adapt to new processes and technologies. Perform diagnostic & analysis of current performance Deliver a relevant business case for implementation Simplify business processes with SME before deploying the digital solution Managing change management and communication planSetting the site Community for Practices and proposing improvement features to Global Product owners, then transitioning to the Business System owner Creating a Global site Digital road map and a Global site performance plan DESIRED QUALIFICATIONS Operational knowledge of biologics/vaccines Previous experience in a digital-based laboratory environment is highly desirable SMS Certified Project Management & Agile methodology Comprehensive understanding of data management and digital products KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC – International is an Equal Opportunity Employer. #J-18808-Ljbffr
