A leading recruitment agency is looking for an experienced Computer System Validation Engineer for a contract opportunity in Dublin, Ireland. The role involves ensuring compliance in computerized systems across manufacturing and laboratory environments in the biopharmaceutical sector. Candidates should have 5-7 years of CSV experience, proficiency in GAMP validation, and strong problem-solving skills. This position supports timely project delivery while collaborating with various engineering and quality teams. #J-18808-Ljbffr
Principal Automation Integration Engineer Full-time | Limerick, Ireland Overview An exciting opportunity is available for a highly experienced Automation Integration Engineer with strong expertise in real-time data acquisition, system integration, and advanced automation platforms within a biopharmaceutical manufacturing environment. This role will sit within a multidisciplinary automation and digital engineering team, responsible for the design, implementation, and support of data acquisition, control, and analysis systems across GMP manufacturing operations. The position offers significant technical ownership, enterprise-level exposure, and the opportunity to influence Industry 4.0 and digital manufacturing initiatives. Key Responsibilities Design, develop, and implement software and hardware enhancements to existing and new automated manufacturing equipment in accordance with formal change control procedures. Integrate industrial automation systems with business applications and enterprise data platforms to enable real‑time data collection and analysis. Troubleshoot automation‑related manufacturing deviations and investigate control system anomalies. Develop and maintain engineering design documentation, technical assessments, and test plans for cGMP process equipment in compliance with GAMP 5 guidelines. Support small to medium‑scale manufacturing, engineering, and validation projects. Provide technical support during automation system design, commissioning, testing, and corrective actions. Author and update system documentation including system specifications, User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS). Generate, execute, and support Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs). Review and assess cybersecurity risks and vulnerabilities associated with automation systems, software, and infrastructure. Create, update, and maintain automation system documentation throughout the system lifecycle. Technical Profile Strong experience with OT systems including SCADA, HMI platforms, historians, and process monitoring systems. Hands‑on experience with advanced data and integration technologies such as OPC UA, MQTT, IIoT platforms, and enterprise data integration tools. Experience designing and supporting large‑scale, enterprise‑level automation and data architectures. Solid understanding of ISA‑95 and ISA‑88 principles and IT/OT integration strategies. Working knowledge of PLC communications, HMI design, and automation process control infrastructure. A continuous improvement mindset with the ability to challenge existing approaches and drive technical excellence. A strong interest in project‑based work and becoming a subject matter expert in supporting reliable, compliant biopharmaceutical manufacturing operations. The ability to manage changing priorities and increasing workloads through effective decision‑making and communication. Qualifications & Experience Bachelor’s degree in Computer Science, Chemical, Mechanical, Electrical Engineering, or a related technical discipline. Relevant experience within regulated biopharmaceutical or life sciences manufacturing environments. Senior Engineer level: minimum 5+ years’ relevant experience. Principal Engineer level: minimum 8+ years’ relevant experience. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Information Technology, Manufacturing, and Engineering Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr
A leading recruitment company in Cork is looking for a Senior Packaging Engineer who will play a crucial role in developing packaging solutions for sterile medical devices. The ideal candidate should have a relevant degree and at least 2 years of experience in the industry. Responsibilities include conducting usability research and leading projects within a cross-functional team. This is a full-time position offering hybrid work flexibility and a 12-month fixed-term contract. #J-18808-Ljbffr
Role Overview A contract opportunity is available for an experienced Computer System Validation (CSV) Engineer to support validation activities across GMP‑regulated manufacturing and laboratory systems within a biopharmaceutical environment. The role focuses on providing hands‑on CSV expertise across the full system lifecycle, ensuring computerized systems are implemented, validated, and maintained in compliance with global regulatory requirements. The CSV Engineer will work closely with engineering, automation, quality, and operations teams to enable compliant and timely project delivery. Responsibilities Contribute to and execute CSV strategies for new and existing computerized systems in line with GAMP 5 and regulatory expectations. Provide independent review and approval of system lifecycle documentation, including plans, requirements, risk assessments, protocols, and reports. Ensure alignment with data integrity, Annex 11, and 21 CFR Part 11 requirements. System Validation Execution Lead and perform CSV activities for GMP‑relevant systems such as DCS (e.g. DeltaV), MES, automated manufacturing equipment, and associated infrastructure. Develop and execute risk‑based validation approaches, including leverage and impact‑based testing. Author, review, and approve validation documentation across commissioning, qualification, and validation phases. Technical Review & Risk Management Review system specifications, design documentation, and installation records to confirm validation readiness. Participate in validation risk assessments to define appropriate testing scope and depth. Identify, assess, and elevate potential compliance or data integrity risks in a timely manner. Generate, assess, and resolve protocol deviations and discrepancies. Support investigations related to validation activities and operational data integrity concerns. Perform periodic reviews of computerized systems and address identified gaps. Project & Stakeholder Support Provide proactive CSV guidance to engineering and project teams to support delivery against schedule. Support validation activities across manufacturing (BDS), packaging, and laboratory Тут. environment. Collaborate with local and global CSV stakeholders to ensure consistency and alignment. Inspections, Safety & Standards Support internal audits and regulatory inspections relating to computerized systems. Contribute to the development and maintenance of SOPs related to CSV, qualification, and operations. Promote safe working practices and support commissioning activities in line with site safety procedures. Experience & Technical Background Required Experience 5–7+ years’ experience in Computer System Validation within pharmaceutical, biopharma, or other highly regulated environments. Proven experience validating GAMP Category 3, 4, and 5 systems. Strong hands‑on experience executing validation protocols and managing validation data. CSV & Regulatory Knowledge In‑depth understanding of GAMP 5, Annex 11, and 21 CFR Part 11. Strong working knowledge of data integrity principles and regulatory expectations for computerized systems. Ability to assess technical and quality impacts and justify corrective actions. Technical Systems Exposure Experience with automation and manufacturing systems such as DCS, MES, and automated process equipment. Familiarity with CSV support across manufacturing, packaging, and laboratory environments. Core Skills Strong problem‑solving and root cause analysis capabilities. Clear written and verbal communication skills. Ability to work independently while contributing effectively to cross‑functional projectλή teams. Proactive mindset with a focus on compliance, quality, and delivery. Education Degree in Engineering, Life Sciences, Computer Science, or a related technical discipline (or equivalent experience). Seniority level Mid‑Senior level-idle Employment type Contract Job function Manufacturing and Engineering Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr
We're Hiring! MES, DCS, PLC, Automation, Robotics, Process Control, IT, OT & IIOT Utility Engineer Permanent | Athlone, Ireland Role Purpose This role provides technical ownership for GMP‑critical utility systems supporting biopharmaceutical manufacturing, including Bulk Drug Substance (BDS) and aseptic Drug Product (DP) operations. The Utility Engineer ensures utilities are operated safely, compliantly, and efficiently, while driving reliability, digital enablement, and continuous improvement across site infrastructure. The position combines day-to-day engineering support with longer‑term lifecycle management, capital project support, and performance optimisation of utility systems in a regulated environment. Key Focus Areas Utility System Performance Ensure reliable operation of GMP utilities to meet manufacturing demand, quality, and availability targets. Analyse system performance, trends, and alarms to improve uptime, energy efficiency, and equipment reliability. Support preventative and condition‑based maintenance strategies. Compliance & Validation Maintain utilities in a validated and inspection‑ready state. Prepare, execute, and review URS, qualification, and periodic review documentation. Manage alarm limits, criticality assessments, and validated state change control in line with GMP expectations. Digital, Data & Automation Use BMS, EMS, CMMS, and historian data to support operational decision‑making. Develop dashboards and reports to track performance, energy usage, and reliability KPIs. Support data integrity, CSV compliance, and digital improvement initiatives. Problem Solving & Investigations Lead technical troubleshooting of utility‑related issues impacting manufacturing. Author and support deviations, investigations, and CAPAs using data‑driven root cause analysis techniques. Apply lean tools such as standard work, visual management, and structured problem solving to reduce waste and unplanned downtime. Identify and deliver energy, water, and cost reduction initiatives. Projects & Lifecycle Support Support utility upgrades, expansions, and obsolescence projects from design through commissioning and handover. Participate in FATs, SATs, and commissioning activities. Coordinate vendors and Record Contractors and review technical documentation and asュ٥ built records. Safety, Quality & Collaboration Promote safe systems of work, permit‑to‑work compliance, and strong EHS behaviours. Work closely with Operations, Quality, Validation, Facilities, Digital/IT, and Finance teams to ensure aligned execution and right‑first‑time delivery. On‑Call Support Participate in out‑of‑hours engineering support as required to maintain continuous and compliant operations. Technical Background Utility Systems Experience GMP utilities including WFI, clean and pure steam, purified water, clean compressed air and gases, HVAC/AHU systems for classified areas, BMS/EMS, chilled and hot water systems, boilers, cooling towers, electrical distribution (LV/MV), and CIP/SIP utilities. Experience supporting commissioning, qualification, and ongoing compliance of utility systems. Strong understanding of P&IDs, specifications, alarm management, calibration, and validated state principles. Digital & Reliability Tools Experience using CMMS platforms, historians, and BMS/EMS trending tools. Working knowledge of data analysis, SPC, and reporting tools (e.g. Excel, Power BI or similar). Exposure to predictive maintenance or reliability‑centred maintenance approaches is beneficial. Experience & Qualifications 3–7 years’ experience in pharmaceutical, biotech, or similarly regulated manufacturing environments. Level 8 degree (or equivalent) in Mechanical, Chemical, Electrical, Mechatronics, Pharmaceutical Engineering, or a related discipline. Strong understanding of GMP, HPRA/FDA utilities expectations, and EHS requirements. Excellent problem‑solving, communication, and stakeholder engagement skills. Ability to work autonomously while contributing effectively within cross‑functional teams. Nice to Have Experience with energy management, digital twins, condition‑based monitoring, or advanced utilities analytics. Certifications in reliability engineering, energy management, or automation/CSV. Seniority level Mid‑Senior level Employment type Full‑time Job function Manufacturing Industries Utilities, Biotechnology Research, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at European Tech Recruit by 2x #J-18808-Ljbffr
A leading technology recruitment firm is seeking a Principal Automation Integration Engineer to join a multidisciplinary team in Limerick, Ireland. The ideal candidate will have extensive experience in real-time data acquisition and system integration within a biopharmaceutical manufacturing environment. Responsibilities include designing enhancements for manufacturing systems, integrating automation with enterprise data platforms, and ensuring compliance with cGMP standards. A Bachelor's degree in a related field and significant experience are required for this role. #J-18808-Ljbffr
A leading recruitment firm in the biopharmaceutical sector is looking for a Utility Engineer in Athlone, Ireland, offering a permanent position. The candidate will be responsible for the performance of GMP-critical utility systems, ensuring compliance and efficiency in biopharmaceutical manufacturing. Key qualifications include a Level 8 degree in Engineering and 3–7 years of relevant experience. This role emphasizes problem-solving, communication skills, and a strong understanding of GMP standards. #J-18808-Ljbffr
Contract | Dublin, Ireland Senior Automation Engineer Overview An excellent contract opportunity for an experienced Senior Automation Engineer to support complex biopharmaceutical and life sciences projects. The role focuses on design and delivery of GMP-compliant automation and control systems, from early concept and Basis of Design (BOD) through detailed design and project execution. This position offers exposure to multi-million‑euro biopharma projects, working within a multidisciplinary engineering environment on regulated manufacturing and fill‑finish facilities. Key Responsibilities Lead the design of automation and control systems for biopharma manufacturing facilities from concept, BOD, and detailed design phases. Develop and review control system design specifications in line with GMP and regulatory requirements. Collaborate with cross‑functional project teams including Process, Mechanical, Electrical, CQV, Quality, and ICT. Select, manage, and technically oversee automation vendors and system integrators throughout the project lifecycle. Review and approve automation design documentation, software design specifications, and vendor deliverables. Ensure automation solutions comply with GMP, data integrity, and regulatory expectations (including GAMP 5 and 21 CFR Part 11). Support and attend hardware and software FATs, SATs, and commissioning activities. Maintain awareness of current automation technologies and industry best practices within biopharma manufacturing. Requirements Degree (Level 8) in Automation, Control Systems, Mechatronics, Electronic Systems, or a related engineering discipline, or equivalent experience. Minimum 7+ years’ experience delivering automation projects within biopharma, pharmaceutical, or regulated life sciences environments. Strong experience in the design and implementation of PLC‑ and DCS‑based control systems. Demonstrated experience in automation software development and system architecture design. Solid knowledge of industry standards and frameworks including S88, GAMP 5, and 21 CFR Part 11. Experience with industrial communication networks (Ethernet, Profinet, Profibus, ControlNet). Ability to read and interpret P&IDs, control philosophies, and panel drawings. Familiarity with GMP manufacturing processes such as upstream, downstream, utilities, fill‑finish, or packaging is highly desirable. Excellent communication skills, with experience working in multidisciplinary and global project teams. Proven ability to manage multiple priorities and deliver to tight project timelines. Proactive, organised, and capable of working independently within a fast‑paced, regulated environment. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Manufacturing and Engineering Industries Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing #J-18808-Ljbffr
A leading recruitment agency seeks a Senior Automation Engineer in Dublin. The role involves driving the design and delivery of GMP-compliant automation systems for biopharma projects. Candidates must have a degree in a related field and over 7 years of experience in automation projects within regulated environments. The position requires strong knowledge of PLC and DCS controls, excellent multitasking abilities, and strong communication skills in a multidisciplinary setting. #J-18808-Ljbffr
We're Hiring! MES, DCS,PLC ,Automation ,Robotics, Process Control ,IT,OT & IIOT Full-time | Cork, Ireland Work Flexibility: Hybrid 12-month Fixed Term Contract Position Summary The Senior Packaging Engineer (R&D Packaging) will be a key member of new product development and sustaining project teams, responsible for developing packaging solutions for sterile medical devices (instruments). The role involves package design verification, shelf-life testing, and compliance-related activities. This position will also lead special projects and research initiatives that have a meaningful business impact. Key Responsibilities Execute packaging usability research and participate in Voice of the Customer activities. Develop packaging solutions for sterile medical devices through design, prototyping, and specification development. Apply development lifecycle knowledge to deliver high-quality technical deliverables. Collaborate cross-functionally with R&D, quality, manufacturing, regulatory, clinical, marketing, supply chain, vendors, and distribution teams across multiple geographies to ensure project success. Embed quality into all aspects of product development by maintaining compliance with quality requirements and driving improvements in complex regulatory environments. Support audits, non-conformances, and CAPAs as required. Lead small-scale packaging projects that drive improvements across the packaging function. Mentor or supervise technical staff when needed. Demonstrate a high level of ownership and professionalism while managing a varied workload and tight timelines. Requirements Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline. Minimum of 2+ years’ relevant experience. Experience within the medical device industry is preferred. Proven experience in medical device, biotech, or pharmaceutical packaging development. Demonstrated ability to resolve design- and process-related packaging issues for commercial products. Working knowledge of Design Controls and relevant industry standards (e.g. ISO 11607, ASTM D4169). Experience with statistical analysis, including interpretation and communication of results. Strong interpersonal and communication skills. Solid technical and project management capabilities, with the ability to deliver project elements on time and within budget. Seniority level Mid-Senior level Employment type Contract Job function Engineering and Manufacturing Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at European Tech Recruit by 2x Get notified about new Packaging Engineer jobs in Cork, County Cork, Ireland . #J-18808-Ljbffr
