This role reports directly to the Engineering Capital Lead and acts as theComputer System Validation (CSV) Subject Matter Expert for a major capital investment programme within a regulated manufacturing environment. The role providesCSV leadership and governance across all GxP-relevant IT/OT systems to ensure delivery in compliance with cGMP, site procedures, and applicable corporate quality standards. The successful candidate will support cross-functional teams including Engineering, Automation, IT/OT, Quality, Operations, and external vendors to ensure compliant execution of commissioning, qualification, and validation activities across the full project lifecycle. Key Areas of Responsibility Validation Governance & Master Planning Support preparation and maintenance of Validation Master Plans (VMPs) for facilities, utilities, equipment, labs, and computerised systems Develop and maintain CSV frameworks, procedures, templates, and lifecycle standards Ensure risk-based validation approach (e.g., V-model) aligned to system criticality and scope Project CSV Delivery (IT/OT & Automation) Provide CSV leadership for IT/OT infrastructure and manufacturing control systems (PLC/SCADA/DCS/PCS) Define governance structures (RACI, system ownership, validation boundaries) early in lifecycle Ensure readiness for FAT, SAT, IQ/OQ/PQ, system release, and handover to operations Validation Documentation Ownership Own/author/review/approve (as applicable): URS and functional/design specifications Risk assessments (GxP, data integrity, cybersecurity) Traceability Matrices (RTM) Test strategies, protocols, and execution (FAT/SAT/IQ/OQ/PQ) Validation reports, release documentation, handover packs SOPs, training impacts, operational readiness documentation Recipe management and change controls Execution Oversight (Testing & Deviations) Oversee validation testing ensuring audit-ready, traceable evidence Manage deviations, defects, CAPAs, retesting, and impact assessments Ensure segregation of duties, access control, and compliant execution Data Integrity & Compliance SME Act as site SME for CSV and data integrity Ensure ALCOA+ compliance across systems and documentation Support audit trail reviews, data lifecycle controls, and electronic records compliance (21 CFR Part 11 / EU Annex 11) Support inspection readiness and audits Change Control & Lifecycle Management Manage validation impact assessments for system changes (GxP, data integrity, security, continuity) Define revalidation and regression testing strategies Maintain lifecycle documentation, periodic reviews, and system configuration control Vendor & Supplier Management Support qualification of GxP system/service suppliers Review and approve vendor validation deliverables Ensure contractual validation responsibilities are defined and met Cybersecurity & Infrastructure Interface Collaborate with IT/OT to ensure validated cybersecurity controls Validate system hardening, access control, backup/restore, and disaster recovery Ensure security controls do not impact GxP functionality Reporting, KPIs & Governance Develop validation dashboards (progress, risks, deviations, milestones) Provide regular reporting to governance forums Escalate risks and blockers with mitigation plans Stakeholder Engagement Participate in project governance and site tier meetings Work with Engineering, Automation, IT, Quality, Operations, and vendors Communicate validation status, risks, and decisions clearly Safety & Quality Ensure compliance with safety and regulatory requirements Promote strong quality and compliance culture Support continuous improvement initiatives Education & Experience Degree in Engineering, Life Sciences, or equivalent 4+ years CSV experience in regulated GMP environments Strong knowledge of GMP systems (21 CFR Part 11 / EU Annex 11) Experience with IT/OT and automation systems Experience in commissioning, qualification, validation lifecycle ISA-88 / ISA-95 knowledge advantageous Key Competencies Strong CSV lifecycle experience in GxP environments Excellent documentation and technical writing skills Strong stakeholder management and cross-functional collaboration Strong planning, prioritisation, and multitasking ability High attention to detail and compliance mindset Ability to work independently and drive delivery Continuous improvement mindset with focus on efficiency and risk reduction Skills: Computer System Validation GMP CSV Validation Master Plans Distributed Control System GxP FDA GMP Benefits: Hybrid Parking on site
Arcadis are seeking a Safety Officer for a Pharmaceutical assignment located in Ringaskiddy, Cork. This is initially a 6-month contract. Responsibilities: Support a portfolio of capital and core engineering construction projects within a live GMP manufacturing environment. Attend daily toolbox talks, whiteboard meetings, and project coordination meetings, providing EHS input to Project Managers and Construction Management Teams. Review, approve, and track contractor safety documentation, RAMS, and task-specific risk assessments via EIDA prior to site execution. Develop, implement, and maintain Construction Health & Safety Plans aligned with regulatory and site EHS requirements. Conduct weekly construction site inspections, EHS audits, and environmental walks, identifying hazards, escalating risks, and tracking corrective actions to closure. Support and monitor permit-to-work systems, including LOTO, confined space entry, hot works, and isolations, ensuring safe systems of work at all times. Deliver and coordinate project-specific safety inductions for all contractors, vendors, and visitors prior to site access. Track, analyse, and report weekly and monthly construction safety statistics, KPIs, incidents, and near misses. Requirements: Degree or Higher Diploma in Safety Health and Welfare at Work, Environmental Science, Engineering, or related field. 12 years of experience in large construction projects, preferably in a GMP-regulated pharma environment. Familiarity with EHS regulations, GMP/GDP standards. Proficient in Microsoft Office and EHS management systems (e.g., EIDA). Strong organizational and communication skills. Why Join Arcadis? At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, youll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.
SAP Business Analyst Kerry (hybrid work option available) The SAP Business Key User acts as the primary business process expert and system representative for SAP within the Manufacturing, Materials Management, and Warehouse Management domains. The role ensures that business processes are correctly designed, documented, adopted, and sustained within SAP, while meeting GMP, data integrity, and regulatory requirements of a pharmaceutical manufacturing environment. The Key User serves as the bridge between business operations and IT/SAP teams, supporting system changes, issue resolution, continuous improvement, and end user capability building. Key Responsibilities Business Process Ownership & Expertise Act as the subject matter expert (SME) for SAP supported business processes in: Production Planning (PP) process orders, master data, BOMs, routings, capacity planning Materials Management (MM) procurement, inventory management, batch management Warehouse Management (WM) goods receipt/issue, storage, picking, staging, and warehouse controls Ensure SAP processes align with GMP requirements, approved SOPs, and validated business processes. Participate in the definition, review, and approval of business process designs, functional specifications, and system changes SAP System Support & Continuous Improvement Provide Level 1 / Level 2 business support for SAP incidents and service requests within PP/MM/WM. Support root cause analysis and resolution of process and master data issues. Identify opportunities to simplify, standardise, and optimise business processes using SAP capabilities. Support SAP releases, enhancements, and local/global template rollouts. Change, Validation & Compliance Support computer system validation (CSV) activities including UAT, defect management, and traceability. Ensure changes follow change control procedures and maintain data integrity. Contribute to audits and inspections by explaining SAP enabled processes and controls. Training & Knowledge Transfer Develop and maintain work instructions, training materials, and SOP inputs for SAP related processes. Deliver or support end user training and act as the first point of contact for process questions. Promote consistent and compliant use of SAP across manufacturing and supply chain teams. Collaboration & Stakeholder Engagement Act as the key liaison between: oManufacturing, Supply Chain, Quality, and Warehouse teams oIT, SAP functional consultants, and external system partners Participate in workshops, testing cycles, and business readiness activities for SAP initiatives. Key Interfaces Manufacturing Operations Supply Chain & Planning Warehouse & Logistics Quality Assurance / CSV IT / SAP Support & External Partners Required Knowledge & Experience SAP & Process Knowledge Strong hands-on knowledge of SAP PP, MM, and WM in a manufacturing environment. Solid understanding of end-to-end manufacturing and material flows in SAP. Experience working with batch management, master data, and transactional processes. Familiarity with SAP ECC and/or S/4HANA in a regulated environment. Pharmaceutical / Regulated Industry Experience working in pharmaceutical or life sciences manufacturing. Good understanding of GMP, data integrity, and validation expectations for GxP systems. Professional Skills Strong analytical and problem-solving skills. Ability to translate business requirements into clear system/process needs. Effective communicator with the ability to work across functions. Detail oriented with a strong compliance mindset. Desirable Qualifications Degree or equivalent experience in Engineering, Supply Chain, IT, or a related discipline. Experience supporting SAP implementations, upgrades, or major enhancements. Prior experience as a SAP Key User, Super User, or Business Process Owner. Role Characteristics Business facing, operationally embedded role High accountability for process quality and system adoption Critical contributor to manufacturing reliability, compliance, and continuous improvement Arcadis is an Equal Opportunities Employer. Recruitment Agencies: Please do not reply to this job advert.
MES Engineer Kerry (hybrid work option available) We are seeking an MES Engineer with a proven track record in designing electronic batch records using PAS-X and working within GMP-regulated environments. This role will work closely with our Systems Team to analyse and map production processes, helping translate these into digital process flow maps for our Manufacturing Execution System (MES) and related platforms. Key Responsibilities Batch Record Design: Design and configure electronic batch records in PAS-X MES based on detailed process requirements. Process Analysis & Mapping: Analyze to-be manufacturing processes and interpret them into clear, logical process flow maps. Collaborate with cross-functional teams (Process, Engineering, Quality, Automation) to gather requirements and map processes. System Build-Out: Support the build and implementation of MES and related systems, ensuring alignment with GMP and regulatory standards. Stakeholder Engagement: Act as a bridge between technical and operational teams, facilitating process workshops and feedback sessions. Documentation & Compliance: Produce high-quality documentation for process mapping, system design, and validation activities. Required Qualifications & Experience Education: Diploma or Bachelors Degree in Engineering, Science, or related technical field. Experience: Minimum 2+ years relevant experience in MES design and implementation within a GMP-regulated pharmaceutical manufacturing environment. Hands-on experience with PAS-X batch record design and configuration. Previous experience in process mapping, workflow design, and system integration. Technical background (Process Technician, MES Specialist, Automation Engineer, etc.) with strong understanding of pharma manufacturing processes. Systems & Tools: Proficiency in MES platforms (preferably PAS-X), process mapping tools, and related digital systems. Soft Skills: Strong analytical skills, attention to detail, and ability to translate complex manufacturing processes into digital workflows. Excellent communication and stakeholder management skills. Ability to work collaboratively across multiple streams and disciplines. Flexible mix of remote work and on-site presence at the Tralee plant as required by project activities. Arcadis | DPS Group is a leading Project Management and Engineering Company delivering Full-Service Engineering with a client first mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time. Arcadis | DPS Group is an Equal Opportunities Employer. Recruitment Agencies: Please do not reply to this job advert.
Validation Engineer - Kerry A new opportunity is now available for a Validation Engineer ideally with a facilities background. The successful Validation Engineer will be responsible for the planning, execution, and delivery of validation activities for facility-based systems within a regulated (cGMP) environment. This role focuses on utilities and infrastructure systems (e.g., HVAC, clean utilities, BMS), ensuring all facilities projects meet regulatory, quality, and operational requirements. The position supports project delivery from design through to qualification and handover. Key Responsibilities: Lead validation activities for facility systems, including HVAC, clean utilities (Purified Water, WFI, Clean Steam), and Building Management Systems (BMS). Develop and execute validation documentation (URS, DQ, IQ, OQ, PQ) in line with project timelines. Assess and manage validation requirements for new installations, upgrades, and change controls. Collaborate with engineering, project management, and quality teams to ensure aligned project execution. Ensure full compliance with cGMP, regulatory guidelines, and company validation standards. Review and approve technical documentation, protocols, and reports related to facilities validation. Support commissioning and qualification (C&Q) activities and ensure effective system handover. Track validation progress and provide regular status updates to stakeholders. Support audits and inspections, responding to regulatory and client queries as required. Contribute to continuous improvement of validation processes and standards. Required Qualifications & Experience Degree in Engineering or Science (or equivalent experience). Proven experience in validation of facility/utility systems within a GMP environment. Strong knowledge of HVAC systems, clean utilities (PW, WFI, Clean Steam), and BMS/EMS. Familiarity with cGMP, GAMP, and regulatory expectations for facilities validation. Experience with commissioning and qualification lifecycle (C&Q). Strong documentation, communication, and stakeholder management skills. Arcadis is an Equal Opportunities Employer. Recruitment Agencies: Please do not reply to this job advert.
Arcadis DPS Engineering are seeking a E&I Project Engineer (Oil & Gas) for an assignment located in East Cork. This is initially a 12 month contract. *Instrumentation only will be considered also Responsibilities: Support Project Manager(s)/Engineers in the delivery of allocated Project works from concept to final delivery & handover. Manage workload of multiple projects of varying complexity. Identification & Engagement of Project Stakeholders to agree an understanding of project drivers & requirements. Support delivery of projects within a standard Project Lifecycle Process. Work with Project Controls, Engineering Services, Procurement, Construction, and Operations departments to ensure agreement of E&I project deliverables. Ensure design is being delivered in line with agreed requirements and company standards. Reviewing design and vendor documentation. Generate and manage E&I cost & schedule estimates. Ensure all project safety documentation is generated such as RAMS, DRA and Preliminary Health and safety plans. Preparation of E&I Work Packages for handover of projects from design to construction phase. Organise and attend project meetings as required, including kick-off meetings, constructability, and safety reviews. Manage & coordinate contractors and vendors for delivery within approved scope, budget and schedules. Coordinate project handover from Construction / Commissioning to Operations. Delivery of project final handover documentation such as packages for design, vendors and construction contractors. Actively coordinate and support the installation and functionality testing of E&I equipment. Requirements: Previous experience supporting E&I deliverables on projects. Instrumentation and/or Electrical Degree qualified preferable. Trade qualification with project engineering experience will be considered. Project management qualification desirable. Knowledge of ATEX compliance. Knowledge of Functional Safety/SIL highly desirable. Why Join Arcadis? At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, youll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.
Snr C&Q Engineer - Formulation & Component Prep About Arcadis Arcadis is the worlds leading company in sustainable design, engineering, and consultancy for natural and built assets. With over 36,000 professionals across 70+ countries, we are united in our mission to improve quality of life and solve the worlds most complex challenges. Be part of something meaningful join us! Snr C&Q Engineer - Formulation & Component Prep Role Overview The C&Q Engineer will support the planning, execution, and documentation of commissioning and qualification activities for equipment, utilities, and processes within the Formulation and Component Preparation areas of a GMP-regulated manufacturing facility. This role ensures systems are delivered in compliance with regulatory standards and are fit for intended use. Key Responsibilities Preparation & attendance at FAT (e.g. parts washer, autoclave) Develop and execute C&Q protocols for formulation vessels, mixing systems, component washers, autoclaves. Collaborate with cross-functional teams (Engineering, QA, Operations) to ensure timely delivery of C&Q milestones. Apply Quality Risk Management (QRM) principles to focus qualification efforts on critical systems. Review and approve URS, design specifications, and test documentation. Track and resolve deviations, change controls, and discrepancies during execution. Why Join Arcadis? At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, youll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future Join Arcadis. Create a legacy. Skills: Validation Commissioning FAT
Snr EHS Specialist About Arcadis Arcadis is the worlds leading company in sustainable design, engineering, and consultancy for natural and built assets. With over 36,000 professionals across 70+ countries, we are united in our mission to improve quality of life and solve the worlds most complex challenges. Be part of something meaningful join us! Snr EHS Specialist Your responsibilities shall cover the following key EHS areas: General Develop, plan, coordinate and monitor DPS-EHS programmes to ensure compliance. Interfacing with sitebased EHS personnel ensuring they are working within the parameters of the DPS safety management structures where applicable and updating them of new developments. Provide direction and guidance to the management team on overall EHS aspects for our sites e.g. Welfare, Safety Statement, Ergonomics, Emergency Response etc. Assist in Incident Investigation where required. Report monthly site safety statistics for DPSs Group Operation. Assist in the co-ordination of Safety Week activities and events across DPS offices and key sites. Project Safety PSCS/PSDP Assist the Project Manager and team in the execution of PSDP and PSCS roles in line with current Construction Regulations e.g. Preparation of Preliminary Safety Plan and Construction Safety Plan, Design Safety Reviews and Safety Files. Provide day to day site safety cover on projects. Ensure site related incidents are investigated satisfactorily and ascertain causes for use in recommending preventative measures - develop EHS procedural revision as necessary. Provide involvement as necessary in project assessments including HAZOPs, Ergonomic, Material Handling, ATEX and design reviews. Provide consultancy in specialised areas. E.g. OHSAS 18001, Ergonomics and Materials Handling, Manual Handling, Seveso etc. Project Environmental Supporting environmental planning or regulatory aspects on a project. Providing involvement as necessary in assessments including Emission Abatement Studies, Baselines assessments including Air, Water, Waste & Noise. Environmental Impact Statement Support. Why Join Arcadis? At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, youll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future Skills: Health & Safety Documentation PSDP
Arcadis are seeking a Mechanical Maintenance Supervisor for an Oil & Gas assignment located in Whitegate, Cork. This is initially a 12-month contract. The successful candidate will lead and coordinate the mechanical maintenance team at a major oil and gas refinery. The role is responsible for ensuring safe, reliable, and efficient execution of all mechanical maintenance activities, supporting asset integrity and reliability strategies. Responsibilities: Supervise and allocate work to the mechanical maintenance team, ensuring compliance with safety and quality standards. Promote continuous improvement in health, safety, and environmental performance. Accept and administer work from planners and area teams, ensuring timely execution. Oversee maintenance on mechanical systems, including piping, exchangers, vessels, furnaces, tanks, steel structures, motors, pumps, compressors, fans, and turbines. Provide regular progress reports and updates on all mechanical maintenance activities. Troubleshoot and resolve technical issues, engaging technical resources as required. Ensure proper close-out and quality control of all work orders, identifying lessons learned. Support turnaround, shutdown, and maintenance campaigns as needed. Recruit, develop, and mentor craft and supervisory personnel within the mechanical team. Collaborate with Operations, Technical, and HSE departments to ensure alignment and resolve issues efficiently. Identify opportunities for efficiency improvements and contribute to the development and implementation of best practices in maintenance execution Requirements: Recognised trade qualification in Mechanical discipline (e.g., apprenticeship, City & Guilds, NVQ, or equivalent). 5+ years experience in mechanical maintenance within the Oil & Gas, Petrochemical, or related heavy industry. At least 5 years supervisory experience, leading diverse mechanical teams. Strong knowledge of maintenance planning and scheduling processes. Demonstrated commitment to health, safety, and environmental compliance. Excellent communication, leadership, and team-building skills. Proficient in MS Office and maintenance management systems (e.g., Oracle). Why Join Arcadis? At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, youll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.
EHS Specialist About Arcadis Arcadis is the worlds leading company in sustainable design, engineering, and consultancy for natural and built assets. With over 36,000 professionals across 70+ countries, we are united in our mission to improve quality of life and solve the worlds most complex challenges. Be part of something meaningful join us! EHS Specialist Position summary: Reporting to the EHS Manager, the EHS Specialist will have both technical and administrative responsibility in the EHS department, The EHS Specialist will participate directly in site projects and provide support to the Dublin PM team where required. In addition, the appointed person should also be able to work in an independent capacity providing a consultancy service capability. The EHS Specialist will be actively engaged in the ongoing implementation of the DPS compliance training and any supporting company safety initiatives e.g. Safety Week, etc. General Develop, plan, coordinate and monitor DPS-EHS programmes to ensure compliance. Interfacing with sitebased EHS personnel ensuring they are working within the parameters of the DPS safety management structures where applicable and updating them of new developments. Provide direction and guidance to the management team on overall EHS aspects for our sites e.g. Welfare, Safety Statement, Ergonomics, Emergency Response etc. Assist in Incident Investigation where required. Report monthly site safety statistics for DPSs Group Operation. Assist in the co-ordination of Safety Week activities and events across DPS offices and key sites. Project Safety PSCS/PSDP Assist the Project Manager and team in the execution of PSDP and PSCS roles in line with current Construction Regulations e.g. Preparation of Preliminary Safety Plan and Construction Safety Plan, Design Safety Reviews and Safety Files. Provide day to day site safety cover on projects. Ensure site related incidents are investigated satisfactorily and ascertain causes for use in recommending preventative measures - develop EHS procedural revision as necessary. Provide involvement as necessary in project assessments including HAZOPs, Ergonomic, Material Handling, ATEX and design reviews. Provide consultancy in specialised areas. E.g. OHSAS 18001, Ergonomics and Materials Handling, Manual Handling, Seveso etc. Project Environmental Supporting environmental planning or regulatory aspects on a project. Providing involvement as necessary in assessments including Emission Abatement Studies, Baselines assessments including Air, Water, Waste & Noise. Environmental Impact Statement Support. Environmental Licensing review Support. Why Join Arcadis? At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, youll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future
