Role Overview Oversee automation systems to ensure maximum uptime and performance. Manage system user access, backups, and restores. Implement corrective actions and collaborate with vendor technical support. Identify and execute small projects to enhance system performance. Contribute to capital planning, project execution, and documentation. Ensure all activities comply with site and corporate Quality Systems. Create and maintain engineering deliverables and test scripts. Develop and implement global automation strategies to standardize processes. Maintain and optimize automation systems and infrastructure. Develop solutions tailored to the manufacturing environment. Drive automation projects, ensuring cost, schedule, and technical goals are met. Your profile Degree in engineering (automation, robotics, computer science, etc.) or equivalent. Proficiency in automation solutions (Siemens, Omron, Mitsubishi, etc.). Knowledge of industry standards (GAMP, ANSI/ISA, 21 CFR Part 11, Annex 11) and GxP/QA. Familiarity with ISPE standards is a plus. Strong problem-solving and analytical skills, with experience in data analysis. Ability to work in a team-based culture, engaging with internal and external stakeholders. Collaborate with Global Automation to implement best practices. Contribute to the innovation road map and strategic planning. Mentor and train team members to enhance site expertise. #J-18808-Ljbffr
We’re supporting a global organisation in hiring a Finance Business Partner (Junior level) to join their team on a 12-month contract, with an immediate start available. This is a great opportunity for a newly qualified ACA/ACCA accountant to step into a business-facing role while working closely with an experienced Finance Manager. The Role Support the Finance Manager with day-to-day financial operations Assist with month-end close, journals and reconciliations Perform variance analysis and financial reporting Support budgeting and forecasting activities Work cross-functionally to provide financial insights to the business Use SAP for financial processes and reporting Requirements ACA or ACCA qualified 2–3 years post-qualified experience (PQE) Strong hands-on SAP experience (essential) Experience in financial reporting / analysis / month-end Comfortable working in a supporting, hands-on role Strong communication skills and ability to work with stakeholders Additional Info Industry background flexible (pharma experience not required) Hybrid working (on-site presence required, no remote-only) Contract: 12 months Why apply? Ideal step into a Finance Business Partnering role Exposure to a high-performing finance team Opportunity to build commercial and stakeholder experience #J-18808-Ljbffr
Overview Opportunity for an experienced Computer Systems Validation Engineer to support a major QC laboratory systems project at a leading global biopharmaceutical manufacturing site. This contract role will support the replacement of existing benchtop analytical instruments within the QC laboratory, including commissioning, data migration and qualification activities. The successful candidate will work closely with project, automation, quality and laboratory teams to support compliant delivery of computerized systems and associated validation activities. Responsibilities Support replacement of benchtop analytical instruments within the QC laboratory Prepare qualification deliverables through planning, specification, verification and reporting Generate and execute test scripts in line with CSV requirements and regulatory expectations Support commissioning, data migration and qualification activities Support deviation management and remediation activities Collaborate with functional teams to support knowledge transfer and robustness of control strategies Support operational excellence initiatives including 5S, Standard Work, Kaizen and problem solving Ensure validation activities are aligned with GMP and data integrity expectations Experience Required Degree in Engineering or Science related discipline Minimum 3 years experience in Validation, QA, CQV or Automation Strong experience in Computer Systems Validation in GMP environments Experience supporting IQ, OQ and PQ activities Experience generating or executing validation test scripts Experience supporting commissioning and qualification activities Working knowledge of 21 CFR Part 11 and Annex 11 Experience supporting deviations, CAPAs and change controls preferred Strong communication and cross functional collaboration skills Preferred Technical Experience Experience with one or more of the following would be advantageous: LIMS Chromatography systems Benchtop analytical instruments Laboratory computerized systems Automation systems Suitable Backgrounds Computer Systems Validation Engineer Validation Engineer Automation Validation Engineer Key Focus This is a hands on execution focused CSV role with emphasis on lab systems, instrument qualification and computerized systems lifecycle support. #J-18808-Ljbffr
A leading pharmaceutical consultancy is seeking an experienced Document Controller for a major capital project in Dublin, Ireland. This fully on-site role involves managing project documentation throughout its life cycle, ensuring compliance with GMP standards and supporting construction and qualification documentation. Candidates must have experience in the pharmaceutical or life sciences sector, along with hands-on proficiency in EIDA and familiarization with platforms like ValGenesis and Kneat. This is a critical role in a dynamic project environment. #J-18808-Ljbffr
Summary Computer System Validation specialist supporting a major capital project at a pharmaceutical manufacturing site. Responsible for ensuring all GxP IT/OT and manufacturing control systems are delivered in compliance with regulatory and quality standards. Works with engineering, automation, IT, quality, and external vendors to deliver commissioning, qualification, and validation activities. Key Responsibilities CSV Leadership & Governance Act as CSV subject matter expert for capital project systems. Support development of Validation Master Plans and CSV strategies. Ensure risk-based lifecycle validation aligned with regulatory expectations. Project Validation Delivery Support validation of manufacturing control systems (e.g. PLC, SCADA, DCS). Ensure readiness for FAT, SAT, IQ, OQ, PQ, system release, and operational handover. Coordinate validation activities across engineering, IT/OT, automation, and quality teams. Validation Documentation Author/review validation documentation including: User Requirements (URS) Functional/Design Specifications Risk Assessments Traceability Matrices Test protocols and reports Validation summary and release documentation Ensure documentation is audit-ready and compliant. Testing & Defect Management Oversee validation test execution. Manage deviations, defects, and CAPA actions. Ensure appropriate access control, data integrity, and approval workflows. Data Integrity & Compliance Ensure ALCOA+ data integrity principles are embedded in systems and validation activities. Support regulatory compliance (e.g. electronic records/signatures requirements). Contribute to audit and inspection readiness. Change Control & Lifecycle Management Support change control processes for validated systems. Conduct impact assessments and define revalidation requirements. Maintain system lifecycle documentation and periodic reviews. Vendor & System Oversight Review vendor validation documentation and leverage supplier testing where appropriate. Support vendor qualification and validation responsibility agreements. Project Reporting & Stakeholder Engagement Track validation deliverables and milestones. Provide updates to project leadership and escalate risks when needed. Collaborate with engineering, operations, IT, quality, and external partners. Experience & Qualifications Degree in engineering, life sciences, or related discipline (or equivalent experience). Experience in Computer System Validation within regulated environments. Knowledge of GxP, data integrity, and computerized system regulations. Experience validating manufacturing automation systems and integrated IT/OT environments. Strong documentation, stakeholder communication, and project coordination skills. #J-18808-Ljbffr
A leading pharmaceutical manufacturer in Ireland is looking for a Computer System Validation specialist to ensure compliance of GxP IT/OT systems on a major project. The role involves authoring validation documentation, overseeing testing procedures, and ensuring risk-based validation aligned with regulatory expectations. We seek someone with a degree in engineering or life sciences and experience in a regulated environment. Strong communication and project coordination skills are essential for successful collaboration across teams. #J-18808-Ljbffr
Thor is seeking an experienced Document Controller to join the client project team on a major pharmaceutical site-based capital project in Ireland. The role is fully on site and responsible for the client-side control and governance of all project documentation across design, construction, CQV and handover phases. Key Responsibilities Client-side control of all project documentation across the full life cycle Manage document receipt, review, approval, issue, revision control and archiving Interface with EPCM partners, vendors, contractors and internal stakeholders Ensure documentation complies with GMP, data integrity and ALCOA+ principles Maintain accurate document registers, trackers and status reports Support CQV documentation, executed protocols and final turnover to operations Support audits, inspections and project close-out activities Essential Experience & Requirements Proven experience as a Document Controller on pharmaceutical or life sciences capital projects Essential: hands-on experience using EIDA for document management Experience working client-side or within an owner’s project team Strong understanding of GMP documentation requirements Experience supporting construction, commissioning and qualification documentation Ability to work full-time on a live pharmaceutical site in Ireland Experience on large-scale Irish pharma projects (drug product, biologics, sterile facilities) Familiarity with ValGenesis, Kneat, ACC or similar platforms #J-18808-Ljbffr
