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. We are looking to add an experienced intermediate CSV Engineer to join the team of our pharmaceutical client based in Tralee, Co Kerry. Key Responsibilities: Assisting in developing validation master plans and project-specific plans for computer systems. Creating essential quality documents like User Requirement Specifications (URS), Traceability Matrices, Test Protocols, and Validation Summary Reports. Executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) tests. Conducting risk assessments and impact analyses for systems and changes. Ensuring systems meet cGMP (current Good Manufacturing Practices) and data integrity standards. Working with IT, Quality Assurance (QA), Operations, and Maintenance teams. Managing validation for system updates and changes. Preparing for and participating in regulatory inspections (e.g., FDA, HPRA). Hands on experience in CSV execution on Delta V, DCS and SCADA/PLC is required. Essential skills and Qualifications Good understanding of core pharmaceutical regulations, specifically FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11 , and GxP (GMP, GLP, GCP) data integrity guidelines. Ability to perform risk assessments and impact analyses (e.g., using GAMP 5 principles) to identify critical functionalities and prioritize validation efforts effectively. Good understanding of data integrity principles (ALCOA+) and experience in implementing and remediating systems to ensure data traceability, transparency, and security. Good skills in technical writing for developing and maintaining validation documentation, including Validation Plans, requirements specifications, test scripts, traceability matrices, and summary reports. Experience in writing, reviewing, and approving Standard Operating Procedures (SOPs) related to CSV and ensuring adherence to internal quality management systems (QMS). Familiarity with change control processes, deviation management, and Corrective and Preventive Actions (CAPA) systems. Experience in participating in both internal audits and external regulatory inspections (e.g., by the FDA or EMA). Typically, a minimum of 3-5 years of relevant CSV experience within the pharmaceutical, biotech, or medical device industry. Strong analytical abilities to troubleshoot complex system issues, identify root causes, and propose effective solutions. Excellent verbal and written communication skills to effectively collaborate with cross-functional teams (IT, QA, Manufacturing, Lab personnel) and manage stakeholders at various levels. A meticulous approach to work, crucial for spotting errors and ensuring strict compliance in a highly regulated 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 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
An international firm specializing in pharmaceutical services is looking for a Qualification and Validation Engineer to lead Process Performance Qualification activities in line with regulatory requirements. Candidates should have a degree in Science or Engineering along with 3–5 years of experience in GMP-regulated environments. The role involves developing strategies, maintaining compliance documentation, and collaborating across functions. Join a diverse team focused on quality and operational excellence in Munster, Ireland. #J-18808-Ljbffr
A global leader in pharmaceutical services based in Tralee, Ireland is seeking a C&Q Engineer to oversee the commissioning and qualification of clean utility systems. This role requires 6-10 years of experience in the pharmaceutical industry and a Bachelor's in Engineering. Responsibilities include developing and executing commissioning protocols, ensuring compliance with regulatory standards, and managing multiple projects. This position offers a 12-month contract with the possibility of extension, immediate start required. #J-18808-Ljbffr
A leading technology company in Munster, Ireland is seeking a Digital Project Manager. This role requires expertise in managing the transition to a cloud-based Laboratory Information Management System while ensuring project success through strategic planning and execution. The ideal candidate should have operational knowledge of biologics and previous experience in a digital laboratory environment. Strong leadership skills and proficiency in project management methodologies are essential. The company promotes an inclusive work culture and 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 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. QUALIFICATION AND VALIDATION ENGINEER Role Overview Lead and support Process Performance Qualification (PPQ) activities in line with global standards and regulatory requirements. KEY RESPONSIBILITIES Develop and execute PPQ strategies (batch sizing, sampling, acceptance criteria, statistical methods) Author and review PPQ protocols, reports, and validation documentation Contribute to the Process Validation Master Plan (PVMP) Support lifecycle changes including tech transfers and post-approval updates Perform risk assessments and apply risk-based validation approaches Ensure timely closure of deviations and CAPAs Maintain audit-ready documentation across the validation lifecycle Collaborate cross-functionally (MSAT, Manufacturing, QC, QA) Support inspections and audits with technical expertise Deliver training and guidance on PPQ activities Design and implement Continued Process Verification (CPV) programs Education & Experience Degree in Science or Engineering 3–5 years’ experience in GMP-regulated pharma manufacturing, validation, or QA Hands-on PPQ experience (design, execution, reporting) Strong background in validation documentation and quality systems Skills & Expertise Strong knowledge of process validation lifecycle and cGMP (FDA, EU, ICH) Experience with statistical methods for validation Familiarity with equipment and systems qualification Proven experience in deviations, CAPA, and change control Strong project management and communication skills Collaborative, adaptable, and solution-focused 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
A leading pharmaceutical company located in Dublin is seeking a qualified QA professional with at least 5 years of experience in the pharma industry. The role involves providing quality assurance oversight for new product introductions and ensuring compliance with cGMP requirements. Candidates should have strong technical proficiency and experience with regulatory inspections. Join us to impact the lives of patients by supporting critical manufacturing processes. #J-18808-Ljbffr
KPC International - Excellence from Concept to Completion C&Q Engineer - Clean Utilities 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. This person will be responsible for all Commissioning and Qualification of utility systems, gasses, chillers, WFI, clean steam in a pharmaceutical environment. Job details: 12 month contract with possibility of extension based in Ireland, Co. Kerry On site role Immediate start Main duties will include: Commission and qualify pharmaceutical utility systems. Develop and execute commissioning protocols, IQ/OQ/PQ documentation, and test scripts for utility systems. Perform field inspections, system walkdowns, and verification of installation against design drawings and specifications. Responsible for ensuring GMP equipment and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations. Responsible for ensuring that all equipment and utilities are tested in compliance with project-related standards from a commissioning perspective. Deviation management associated with the assigned equipment and utilities. Collaborate with Engineering, Validation, QA, and Operations to ensure seamless integration of utilities into GMP operations. Support risk assessments, impact analyses, and change control processes for utility systems. Execution of FAT testing and leveraging results into the overall qualification process for assigned equipment, facilities and utilities. Experience Required: Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field. 6 - 10 years of experience in Clean Utilities Commissioning, Qualification, and Validation in a pharmaceutical or biotechnology setting. Demonstratable capacity to effectively execute the CQ testing approach assigned from initiation to completion. Experience with CQ of High Purity Water systems, Purified Water & WFI Generation and Distribution systems, as well as Clean Steam and High Purity Gas Systems. In-depth knowledge of regulatory requirements, including cGMP, FDA, and other relevant standards. Strong project management skills and ability to manage multiple projects simultaneously. Excellent communication and interpersonal skills for effective collaboration with cross-functional teams. Proven ability to work independently and make informed decisions to support clean utility operations. KPC-International is an Equal Opportunity Employer who offer an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. #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 Responsibilities Provide QA oversight for new product introduction in Bulk Drug Substance facility. Serve as site QA expert on all compliance topics related to manufacturing. Review and approve project documents across Operations, Engineering, QC, QA, Facilities, and others. Review and approve validation documents for equipment, software, facilities, utilities, IT systems, test methods, and cleaning processes. Approve process descriptions, sampling plans, operational procedures, process and cleaning validations. Review and approve TRA’s, MSRs, SAP requests for new products. Ensure materials are sampled and released per specifications and procedures. Investigate and approve deviations during qualification/validation testing. Participate in project change control programs and equipment modifications. Guide project teams on validation strategies and regulatory compliance. Review documentation, investigations, and reports to identify and resolve issues by risk level. Maintain schedules for GMP document review and approval to support Commercial Operations. Provide QA support to manufacturing, engineering, utilities, supply chain, and material movement. Support deviation investigations, root cause analysis, and CAPA initiatives. Actively contribute to audit readiness and regulatory/internal inspections. Qualifications Minimum 5 years’ experience in pharma or related industry. Strong knowledge of cGMP requirements; sterility assurance experience preferred. Hands-on experience in GMP management and exposure to FDA, HPRA/EMA, or similar regulatory inspections. High accuracy, attention to detail, and technical proficiency. Knowledge of Delta-V, Veeva Vault, or similar systems. Strong planning, organisation, analytical, auditing, and regulatory skills. 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 pharmaceutical services company based in Ireland seeks a Quality Assurance Lead to establish and lead a compliant quality management system. You will oversee QA processes across operations and ensure adherence to global regulatory standards. The ideal candidate has extensive experience in pharmaceutical QA and a strong leadership background. This role emphasizes quality, compliance, and continuous improvement to support life-changing products. #J-18808-Ljbffr
