Summary: We are seeking a Mechanical/Electrical Construction Manager to join a project at our client site in Dublin. The successful candidate will have previous experience in Mechanical/Electrical Construction Management on a manufacturing site. Responsibilities: Mechanical construction management for mechanical equipment and piping, installation of mechanical equipment, vessels, pumps, skids and others. Ensure optimum Health & Safety on site at all times. Construction field co-ordination. Coordinate contractor activities to monitor and track work, ensuring delivery of the schedule and budget. Participate in Constructability, Planning and Safety reviews. Proficiency with reading and interpreting standard construction documents, drawings, schedules, contracts and proposals. Review and contribute project scope, budget and schedule. Ability to manage workload of multiple projects of varying complexity. Qualifications & Experience: Have a strong mechanical or electrical background. Minimum of 5 years experience in relevant construction projects. Ability to manage workload of multiple projects of varying complexity. Proven experience in coordinating mechanical construction works, including managing the mechanical construction contractor to ensure all aspects of their delivery meet project goals of safety, quality and schedule. TPBN1_IJ
Summary: A Project Portfolio Lead is required for a biopharmaceutical company in Waterford. The successful candidate will join a team responsible for overseeing and delivering projects across the site. Responsibilities: Lead cross-functional, multi-site teams in the introduction and business integration of Dupixent DS. Translate customer and business needs into defined, approved project scope statements. Work with functional managers to quantify resource requirements across the cluster. Establish detailed project plans and drive execution of project tasks in line with agreed scope, schedule, and cost. Run regular project meetings to lead and influence the project, adhere to scope, and ensure timely completion according to schedule; establish and execute a communication plan and facilitate information flow between stakeholders and sites. Drive project risk identification, analysis, response, and implement & monitor mitigations to minimise impact to the project or wider business Facilitate cost estimation to determine project budgets and drive adherence to budget and forecast submission. Project Stakeholder Management analyse stakeholder expectations and their impact on the project, and develop appropriate management strategies for effectively engaging stakeholders in project decisions and execution Raise, author, and manage change controls in accordance with Sanofis Quality Management System (QMS) and site SOPs. Coordinate and track the execution of change control tasks across cross-functional teams, ensuring timely completion of all actions. Manage change control workflows ensuring compliance with GMP and regulatory requirements. Conduct post-implementation reviews to confirm changes have been effectively executed and documented. The Project Portfolio Lead is responsible for GMP documents in line with Waterford site procedures; therefore, training to Waterford GMP systems is required. Qualifications & Experience: Degree in Science, Engineering or equivalent. Experience in the biopharma industry, in a project leadership role. Demonstrated experience in project/program management in drug substance or drug product. Demonstrated experience in change control management within a GMP-regulated environment. Working knowledge of cGMPs, GLP, etc. TLNT1_IJ
Summary: An NPI QA Specialist is required for a biopharmaceutical company is West Dublin. The successful candidate will be responsible for delivery of quality assurance activities onsite to ensure new products are introduced and manufactured in accordance with cGMP, corporate and regulatory requirements. Responsibilities: Quality Oversight for new product introduction in the Bulk Drug Substance facility. Quality oversight for new or modified facilities, equipment, technologies, including analytical, as well as other continuous improvements and requalifications. Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to the manufacturing facility . Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, Equipment and others. Review and approval of qualification/verification/validation documents for facilities, equipment, processes, analytical methods, suppliers, software and others. (e.g. URS, Facility, Utility, IT Systems, Test Methods, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures. Quality oversight on operations and technical services to review and approve Process descriptions , sampling plans, operational procedures, process validation and cleaning validation documents . Review and approve TRAs, MSRs, SAP requests related to new products . Provide QA support for supplier qualifications. QA review all analytical facility, equipment and method qualifications and validations. Ensure all Materials are sampled and released as per the approved specifications and procedures . Investigation and approval of deviations generated encountered during qualification/validation testing. Participation in the project change control program and deviations for modifications to new and existing systems. equipment. Provide guidance to project teams on Quality regulations for Validation strategy and approach. Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups. Provide sound QA and Compliance support to manufacturing, engineering, automation, utilities, supply chain, and material movement and laboratories. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Actively support audit readiness activities and regulatory agency and internal audits. Qualifications & Experience: Third level qualification e.g. B.Sc. in science/pharmacy. A minimum of 6-8 years relevant experience within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault or similar Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities. High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required. Previous QA experience aligned to Technical Services, Engineering/CQV reviews, operational (batch records, procedures), supplier qualification, packaging lines, warehousing (including temperature mapping of, along with fridges and freezers) and QC analytical qualifications/validations and laboratories of particular interest. TPBN1_IJ
Summary: Our client, a leading biopharmaceutical company based in East Cork, is seeking an Accountant to join their team. The successful candidate will be responsible for preparing transactional and accrual journal entries, reconciling payroll-related general ledger accounts, performing payroll data audits, and supporting additional finance projects as required. This role will involve the timely and accurate review and posting of month-end close activities and accounting transactions, along with detailed P&L and balance sheet analysis, reconciliation, and issue resolution. The team currently manages payroll operations across approximately 45 countries within the EMEA, APAC, LATAM, and Canada regions, offering excellent exposure within a global finance environment. Responsibilities: Responsible for month-end and year-end close activities including preparation of monthly payroll related journals, accruals, and adjustments, all in accordance with company policy and accounting guidelines. Prepare month-end reconciliations for payroll related balance sheet accounts and actively manage any open items. On a monthly basis review reconciliations completed by the Payroll Specialists, ensuring any reconciling/aged items are tracked and cleared before next month end. Manage hypo tax accruals & reconciliations. Support with preparation of the budget and actively manage the payroll PO. Partner with mobility partner on hypo tax/mobile employees. Partner with RTR accountants & finance teams to answer and support on queries related to payroll accounting and attend monthly calls. Support the Payroll Specialists with month/qtr./year end-end activities. Interact successfully with internal and external auditors and support quarter-end, interim and year-end audits by providing timely and accurate data and communication. Lead & support on balance sheets reviews. Liaise with Controllership on requests. Support with ad-hod business reporting. Lead & support the team with SOX controls. Provide knowledge, training & support. Work with payroll managers to recommend and lead improvements and process enhancements. Create and update standard operating procedures (SOPs) at regular intervals. Support & lead ad-hoc finance-related projects and systems testing as assigned. Work with the payroll provider to map new elements to GL, understand how payroll reports are linked e.g. GTN/GL Provide a monthly update to management team. Qualifications & Experience: Bachelors Degree in an appropriate field of study or equivalent work experience. Qualified Accountant or individual with an equivalent accountancy qualification, with a fundamental understanding of operating within a multi-country environment in a multinational corporation. Proven working experience in Accounting, Finance, and/or Payroll roles. Experience working within a global finance function in a multi-location, multinational corporation. Strong working knowledge of SAP. Proficient in the use of Microsoft Excel, Word, and PowerPoint. TPBN1_IJ
Summary: A leading biopharma company in Limerick is seeking a Projects Safety Advisor responsible for ensuring compliance with EHS requirements, supporting project teams on site, and ensuring that documentation, procedures, and quality standards are fully implemented and adhered to. Responsibilities: Lead and coordinate Environmental, Health and Safety (EHS) programmes across all CAPEX projects. Provide EHS support and oversight to project teams, ensuring compliance with company standards, Irish legislation, and industry best practice. Participate in all project phases, offering guidance on design-stage safety, construction activities, commissioning, and handover. Develop, review, and maintain project EHS documentation, including risk assessments, method statements, safe systems of work, and project safety files. Identify project-related hazards and design suitable control measures, ensuring risks are effectively communicated and implemented. Conduct regular site inspections, audits, and performance reviews to monitor compliance and drive continuous improvement. Liaise with vendors, contractors, and internal stakeholders to ensure alignment with EHS requirements and verify accurate documentation. Support the creation and review of Construction EHS Plans in collaboration with Project Managers. Deliver EHS training, briefings, and toolbox talks to project engineers, managers, and contractors as required. Contribute to incident investigations, root-cause analysis, and corrective actions to prevent recurrence. Promote a proactive safety culture within the Projects Group by driving engagement, awareness, and accountability. Responsible for regulatory submissions to the HSA. Qualifications & Experience: Third-level qualification in Occupational Safety, Health, Environmental Science, or a related discipline. Minimum of 5 years experience in an EHS role, ideally within the biopharma, pharmaceutical, or life sciences sector. PSCS and PSDP experience a distinct advantage. Proactive approach to risk management, with a focus on quality, compliance, and continuous improvement. TPBN1_IJ
Summary: A CAD Technician is required to support an ongoing project at a leading biopharmaceutical company inLimerick. The successful candidate will be responsible for developing and maintaining technical drawings and design documentation across multiple disciplines. This is a short-term contract role with an immediate start preferred. Responsibilities: Produce high-quality 2D drawings for both mechanical and electrical services. Develop layouts, detailed planning, and construction drawings. Coordinate design packages across multiple disciplines. Extract model data and ensure accurate document control. Conduct site surveys to gather essential design information. Provide procurement support as required. Generate detailed working drawings aligned with client specifications. Prepare technical reports, specifications, and schedules. Assist in workload planning and coordination within the team. Qualifications & Experience: A relevant qualification in CAD or a related field. Minimum of 1 year relevant experience working in a consultancy or contractor environment. Proficiency in AutoCAD (Navisworks and Revit experience preferred). Experience in mechanical, electrical, or HVAC design is desirable. Strong attention to detail with the ability to manage multiple tasks effectively. TPBN1_IJ
Summary: A Project Portfolio Lead is required for a biopharmaceutical company in Waterford. The successful candidate will join a team responsible for overseeing and delivering projects across the site. Responsibilities: Lead cross-functional, multi-site teams in the introduction and business integration of Dupixent DS. Translate customer and business needs into defined, approved project scope statements. Work with functional managers to quantify resource requirements across the cluster. Establish detailed project plans and drive execution of project tasks in line with agreed scope, schedule, and cost. Run regular project meetings to lead and influence the project, adhere to scope, and ensure timely completion according to schedule; establish and execute a communication plan and facilitate information flow between stakeholders and sites. Drive project risk identification, analysis, response, and implement & monitor mitigations to minimise impact to the project or wider business Facilitate cost estimation to determine project budgets and drive adherence to budget and forecast submission. Project Stakeholder Management analyse stakeholder expectations and their impact on the project, and develop appropriate management strategies for effectively engaging stakeholders in project decisions and execution Raise, author, and manage change controls in accordance with Sanofis Quality Management System (QMS) and site SOPs. Coordinate and track the execution of change control tasks across cross-functional teams, ensuring timely completion of all actions. Manage change control workflows ensuring compliance with GMP and regulatory requirements. Conduct post-implementation reviews to confirm changes have been effectively executed and documented. The Project Portfolio Lead is responsible for GMP documents in line with Waterford site procedures; therefore, training to Waterford GMP systems is required. Qualifications & Experience: Degree in Science, Engineering or equivalent. Experience in the biopharma industry, in a project leadership role. Demonstrated experience in project/program management in drug substance or drug product. Demonstrated experience in change control management within a GMP-regulated environment. Working knowledge of cGMPs, GLP, etc. TPBN1_IJ
Summary: A Regulatory Site Officer is required for a biopharmaceutical company in Waterford. The successful candidate will join the team responsible for managing products manufactured onsite from a regulatory perspective; ensuring submissions are submitted on time, assessing change controls and deviations and ensuring regulatory compliance. Responsibilities: Maintenance of, and variations to, CMC Dossier for assigned products. Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs). Assess the regulatory impact of proposed changes by site for assigned products. Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/ technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate. Second RSO review for submission documentation. Track all site regulatory activities in real time within the site planning tracking tools. Monitor submission/approval status and track updates for assigned products. Participate in regulatory inspections/audits. Initial BLA/MAA authoring/coordination, as appropriate. Product Registration Renewals. Annual Reports e.g. US, Canada, Brazil. Periodic Quality Reviews (PQR). Contribute in project teams and provide regulatory guidance/ support. Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites. Regulatory or Dossier Compliance. Creation and maintenance of Overarching and Batch specific MARs/MCAs. Legalisations and notarisation requests. Preparation of Site Master File (SMF). Maintenance of local site accreditations e.g. investigational manufacturing license (IMP), manufacturing license and GMP certification. Site Registrations & Renewals e.g. Foreign Manufacturing Registration (FMR). Distribution of approval notification to site. Document review (Veeva Vault). Ensure Quality tasks are completed in timely manner. Qualifications & Experience: Degree in Science, Pharmacy or related discipline is essential. 2 years+ relevant experience. Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable. TPBN1_IJ
Summary: Our client, a leading pharmaceutical manufacturing company based in East Cork, is seeking an experienced Project Scheduler to join their Capital Projects team. The successful candidate will be responsible for developing, maintaining, and managing project schedules across a portfolio of capital projects. This role will support project delivery by providing clear visibility on timelines, risks, and progress, working closely with cross-functional teams to ensure alignment with project objectives and timelines. Responsibilities: Develop, maintain, and update detailed project schedules using Primavera P6 and Microsoft Project. Work closely with Project Managers, Project Controllers, and cross-functional teams, including Engineering, Procurement, and Construction to define project scope, milestones, and deliverables. Support baseline schedule development, progress tracking, and forecasting activities across multiple projects. Monitor critical paths, identify potential delays, and provide early warning along with recovery plans. Manage and incorporate change events into project schedules, including scenario planning to assess potential impacts. Support resource planning and levelling across concurrent projects. Generate regular progress and performance reports, including milestone tracking, variance analysis, and schedule performance metrics. Participate in project review meetings and contribute to status reporting and schedule risk assessments. Ensure all schedules are developed and maintained in line with internal procedures and regulatory expectations. Collaborate with cost control teams to integrate cost and schedule data for reporting and project tracking. Contribute to the continuous improvement of scheduling processes and project controls practices. Qualifications & Experience: Degree in Engineering, Project Management, or a related discipline. Minimum 37 years experience in project planning or scheduling, ideally within pharmaceutical, biopharmaceutical, or related regulated environments. Strong experience using Primavera P6 and Microsoft Project for complex project scheduling. Good understanding of project lifecycles, including engineering, construction, and commissioning activities. Experience in resource loading, progress measurement, and schedule risk analysis. Strong communication skills with the ability to work effectively across cross-functional teams. High attention to detail with strong analytical and organisational skills. Experience with project controls tools and reporting systems (e.g. Excel, Power BI). Ability to manage multiple priorities in a fast-paced project environment. TPBN1_IJ
Summary: Our client, a leading biopharmaceutical organisation based in Waterford, is seeking an Equipment Project Engineer to deliver a portfolio of capital and automation-related projects across manufacturing and operational areas, including biologics, oral dosage, medical devices, laboratories, and packaging. The successful candidate will manage projects end-to-end, ensuring delivery in line with schedule, cost, quality, and scope requirements, while collaborating with cross-functional teams and external partners to support equipment upgrades, system implementations, and operational improvements within a GMP-regulated environment. Responsibilities: Deliver multiple Automation Related projects, primarily virtualisation of servers associated with live production equipment. Deployment will occur in defined shutdowns requiring excellent co-ordination. Management of multiple groups, Global & local ITS teams, Automation, Validation and Production teams along with specialist external contractors. Develop solutions along with 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 team environment on several projects deployed in a phased nature. Deliver on packaging, serialisation & aggregation biopharmaceutical equipment project portfolio within our clients biopharmaceutical operations which include enzyme,monoclonal antibodies(mAbs), oral dosage, medical device, laboratories & packaging operations. Perform procurement, acceptance of equipment & associated infrastructure on behalf of client and report regularly on project status throughout the project lifecycle. Management of end-to-end project lifecycle is key to success. Ensure compliance 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 right first-time project deployment. Chair and Interaction with assigned project teams to interpret their requirements and ensure approval to align project scope as requested. Assign responsibilities, mentor project team and maintain accurate project planning documentation as defined by the client the stage gate model for project delivery. 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. Qualifications & Experience: Degree in Mechanical, Chemical, Industrial, or a related Engineering discipline (Masters degree or relevant project management certification is advantageous) Minimum 10 years experience in project engineering or project management roles within a regulated environment Strong experience working within a cGMP pharmaceutical or biopharmaceutical environment Proven experience managing capital projects and equipment-related initiatives Strong knowledge of automation systems and control system upgrades Experience supporting equipment procurement, commissioning, and qualification processes TPBN1_IJ
