Summary: Our client, a biopharmaceutical company located in Carlow, is seeking a Facilities Engineer. The ideal candidate will be responsible for planning, implementing and maintaining the infrastructure and equipment of buildings and facility related equipment at the site. This includes but is not limited to analysis of processes within the Facility and Utility Support functions of the Engineering department with a view to identifying and implementing improvements, supporting ongoing project activity by participating in safety inspections and walks, participating in sustainability initiatives and general support to the wider Engineering group. The successful candidate will have prior relevant facility engineering experience, preferably gained in a GMP manufacturing setting, with experience providing support to the Facility and Utility Support functions. Responsibilities: Collaboration with other departments and our out-sourced partners to ensure the successful delivery of the Facility and Utility Support function in the safest, most time efficient and cost-effective manner. Maintain Facility and Utility Support services in the context of retaining a permanent inspection readiness state for the site. Support continuous improvement by active participation in projects, system failure studies and incident investigations using recognised methodologies such as 8SPS, RCA, among others. Support the development and execution of Change Control related to the Engineering function. Participate in and contribute to Lean measures such as Gemba and Kaizen events. Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participate in audits and inspections and proactively highlighting any issues around compliance. Escalate issues in a timely manner to relevant onsite stakeholders and support the resolution of any such issues. Development of new and review and update of existing SOPs. Support site Reliability and Calibration improvement programs. Collaborate closely with cross functional teams to ensure project activity is supported through inspection and safety walks. Work collaboratively to drive a safe and compliant culture in the site. Collaborate with multiple partners (e.g., IPT, Supply Chain, Warehouse, Quality, Labs, Third Parties and Vendors). Drafting presentations and reporting out on progress on initiatives to stakeholders as required. Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on-site activities. Responding to safety events, collecting information and coordinating investigations and remediation actions. Responding to building fabric issues, collecting information to support investigations and coordinating closure of remediation actions. Supervision of temporary building utilisation and responding to issues as they arise. Overseeing building utilisation and conducting periodic occupancy checks. May be required to perform other duties as assigned. Qualifications & Experience: Bachelors Degree or higher preferred; ideally in an Engineering, Science or other technical discipline Lean Six Sigma Methodology experience desired, with Green Belt preferred. Considerable experience in a comparable role typically gained operating as an independent contributor, adding considerable value to the business. Experience within Facilities and Utilities support areas in a GMP manufacturing environment, and have a proven track record in identifying and delivering improvement projects. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Proficiency in Microsoft Office suite and job-related computer applications required.
Summary: Our client is a biopharmaceutical company based in Dublin South, looking for a Project Manager will lead the planning, execution, and delivery of capital, engineering, infrastructure, and EHS-related projects This role ensures projects are delivered safely, on scope, on schedule, and within approved budget, with a strong emphasis on forecasting, risk management, and stakeholder communication. Projects will include facilities upgrades, utility systems improvements, sustainability initiatives, and manufacturing support projects (e.g., heat pump upgrades, sitewide printer upgrades, biodiversity works, and CAPEX initiatives referenced in the department updates). Responsibilities: Define project scope, objectives, deliverables, and success criteria with internal stakeholders. Develop Project Charters, URS documents, risk assessments, and WBS structures. Manage scope changes through formal Change Control processes in alignment with QA, EHS, and Engineering governance. Ensure alignment of scope with site strategies including Energy, Sustainability, EHS Create detailed project schedules, identifying milestones, dependencies, and critical paths. Manage and track timelines through project lifecyclefrom concept, design, procurement, installation, commissioning, validation, and handover. Lead coordination with cross-functional teams (Maintenance, EHS, FM, Manufacturing, QA, IT/OT). Monitor schedule adherence and proactively implement recovery actions to avoid delays. Report schedule monthly performance at departmental and governance forums. Develop CAPEX and OPEX budgets, ensuring accurate early-stage cost estimation. Manage project expenditures, purchase orders, contractor costs, and cashflow. Maintain accurate monthly forecasting, incorporating accruals, committed spend, grant funding (e.g., SEAI), and year-end financial projections. Identify cost-saving opportunities and ensure alignment with site efficiency targets. Present financial updates at Engineering & EHS reviews and support site budgeting cycles. Ownership of project forecasting for all active projects, ensuring visibility from concept through completion. Analyse variances and implement corrective actions for budget, schedule, and resource deviations. Prepare monthly project dashboards and input to corporate reporting channels. Track performance against site KPIs including CAPEX utilisation, efficiencies, CO2savings, energy metrics, and EHS indicators. Lead project risk assessments, ensuring mitigation plans are identified and implemented. Ensure all project activities comply with EHS standards, GMP, and Ipsen Engineering policies. Prepare documentation required for inspections, grant applications (e.g., energy projects), and audit readiness. Manage contractor safety and site permitting in collaboration with EHS. Coordinate internal and external stakeholders: engineering specialists, EHS, operations, procurement, consultants, vendors, and construction contractors. Chair project meetings, issue minutes, and track actions to closure. Ensure high-quality communication and expectation alignment across the project lifecycle. Oversee installation, commissioning, validation, and handover of systems and equipment. Support operational readiness planning, SOP updates, training, and maintenance handover. Drive project closure including MSCRs, SLAs, documentation packs, and lessons learned. Qualifications & Experience: Bachelors degree in Engineering, Construction Management, Project Management, or related field. 5+ years experience managing engineering or CAPEX projects in biopharma, pharmaceuticals, medical devices, biotech, or related regulated industries. Demonstrated expertise in scope, schedule, and cost control, including full lifecycle project ownership. Strong experience in financial forecasting, cost reporting, and CAPEX governance. Understanding of GMP environments, EHS compliance, and change control systems. Proven experience in managing contractors, service providers, and multi-disciplinary teams. Proficiency with MS Project or equivalent scheduling tools. Experience with sustainability projects (e.g., energy efficiency, heat pumps, ISO 50001). Experience with utilities systems (BMS, HVAC, boilers, water systems). Knowledge of procurement and tendering processes. Project Management certification (PMP, Prince2, IPMA, or equivalent). Experience working in a campus/manufacturing environment with multiple active work fronts. Strong leadership and interpersonal skills Analytical problem-solving Strong financial discipline & forecasting accuracy Excellent communication and stakeholder influence Ability to manage multiple concurrent projects
Summary: Our client, a leading biopharmaceutical manufacturing site in Dublin, is seeking a LIMS Project Analyst to support the deployment and ongoing configuration of Labware LIMS V8. The successful candidate will be responsible for developing and maintaining LIMS master data, as well as supporting the effective setup, verification, and rollout of LIMS functionality to support manufacturing, QC testing, and product release. Responsibilities: Configure and maintain LIMS setups, including microbiology and QC analytical methods, product specifications, schedulers, standards and reagents, COAs, labels, printers, and associated master data Create, build, and verify LIMS master data to support testing and release activities Develop test scripts and test protocols to support structured LIMS verification activities Execute informal and formal verification testing in collaboration with Computer Systems Validation (CSV) resources Facilitate user review workshops, walking stakeholders through configured LIMS functionality and incorporating updates prior to design finalisation Support end users through training material development and training execution Provide troubleshooting support during hyper-care and escalate issues to relevant IT and LIMS support resources Contribute to the development of LIMS documentation, including configuration/design specifications and design notes Support LIMS hardware setup activities in collaboration with relevant technical teams Analyse user requirements and support LIMS design in collaboration with business users and project stakeholders Configure interfaces between LIMS and analytical equipment, associated software, and SAP where required Collaborate with cross-functional stakeholders, including QA, QC, Manufacturing, Project Management, Labware technical SMEs, and internal LIMS administrators Lead or coordinate elements of the LIMS project stream, including task management, stakeholder follow-ups, supplier follow-ups, and issue escalation Support other LIMS-related tasks as assigned by the Project Lead or Project Manager Qualifications & Experience: Bachelors degree in Life Sciences, IT, or a related scientific discipline Minimum 1 year of experience in LIMS administration and/or LIMS master data building Experience working in finished product pharmaceuticals and/or biologics environments, within areas such as QC, QA, analytical chemistry, development, or manufacturing Strong understanding of quality systems and cGMP requirements Experience working with Labware LIMS (V8 ideally) is highly desirable Experience supporting system validation activities in a regulated environment is beneficial
Summary: Our client is a global pharmaceutical company based in East Cork currently expanding its existing facility. The Cost Controller will be responsible for the project budget control, cost forecasting, cost reporting and cost risk analysis. Responsibilities: Ensures all cost reporting, analysis, and forecasting performance is appraised in detail. Ensures preparation of monthly and yearly rolling forecasts for the operative year with analysis of variances from the agreed baseline budget. Implements the Project Controls Plan (PCP) with respect cost management and control. Owns and manages the project budget, cost risk, value improvement, change management, reporting, contingency, benchmarking processes, as described in the PCP. Monitors, tracks and reports progress, cost, risk performance and forecasts, with trends and variances analysed. Shares best practices learned from other projects and promotes commercial awareness in the project team. Applies Cost Control governance to ensure Cost Control is consistent with on time and quality commitments. Ensures that regular cost, risk and change analysis and reports are produced and advises the Project Manager of any forecast cost overruns as soon as possible, to allow corrective actions to be taken in a timely manner. Participates in project reviews, risk and opportunity meeting and workshops, providing support in the identification, challenging and mitigation of project cost risks. Liaises with the finance department to establish monthly evaluation of work done, goods received and services rendered for invoice preparation and validation to ensure supplier invoices are managed in accordance with the agreed invoice process for the project. Participates in the bidding and selection of work packages and supports the commercial bid analysis, contract negotiations and award process for each work package. Ensures that all cost related work is following agreements and participates in Final Accounts. Reviews and approves all project performance metrics. Maintains all required Cost Control Registers e.g., Cost book , Purchase Order & Invoice Registers, Change Management Registers etc. Provides weekly cost updates to the Project Manager and Finance. Escalates cost issues to the Project Manager, in line with governance requirements for the project. Participates in lessons learned workshops, project closeout and ensure all benchmarks for a project or portfolio of projects is maintained and communicated to the Project Manager. Qualifications & Experience: Engineering and Business qualification, with a minimum of 5 years experience implementing Capital Projects Cost Control for pharmaceutical facility capital projects. Knowledge of the different forms of Agreement for capital projects and the implementation of the same for work packages. Experience in the development of Capital Project Cost Control processes and procedures and the delivery of the same to agreed key milestones for large capital projects in the Pharmaceutical industry. Experience in using Enterprise Resource Systems (ERP) systems e.g., SAP, Agora etc., to manage and report cost for a project. Proficient in the use of Word, Excel, PowerPoint etc. Experience in managing a range of suppliers e.g., design, construction, equipment, professional services etc. and the cost challenges that attach to the same. Experience in the administration of contracts in strict accordance with a signed Agreement.
Summary: An External Manufacturing Lead is required for a biopharmaceutical company in West Dublin, supporting commercial and clinical drug substance (DS) manufacturing. The successful candidate will provide scientific and technical leadership across tech transfer, process validation, process monitoring, scale-up, troubleshooting, and continuous improvement activities, ensuring processes remain compliant and in a validated state throughout their lifecycle. This role will work closely with internal stakeholders across Technical Operations, Process Development, Analytical Sciences, Quality Assurance, and Regulatory Affairs, and will also support CMC documentation for regulatory submissions. Responsibilities: Provide technical and scientific oversight of ongoing commercial and clinical drug substance manufacturing at external CMOs Support and lead technology transfer activities for DS processes, ensuring robust technical execution and effective cross-functional alignment Provide technical direction for process optimisation initiatives, including efficiency and capacity improvements, using AI tools where applicable Drive continuous improvement initiatives to improve yield and reduce cost of goods (CoGs) through data-driven and statistically supported approaches Partner with Quality Assurance and Regulatory colleagues to ensure external manufacturing processes remain compliant, inspection-ready, and in a validated state throughout their lifecycle Oversee process monitoring activities for external manufacturing (continued process verification), including trending and statistical analysis of process performance Support process troubleshooting and investigation activities for external manufacturing, including root cause identification and definition of corrective actions Support the preparation, review, and approval of CMC sections for regulatory submissions (e.g., NDA/MAA) and other technical documentation associated with commercial and clinical DS manufactured at CMOs Communicate manufacturing status, technical risks, and key activities to internal stakeholders and management through written updates and formal and informal presentations Support external site readiness for audits and inspections, and present and defend technical aspects of DS manufacturing operations as required Qualifications & Experience: Degree in scientific discipline (e.g., Biochemistry, Chemistry, Pharmacy), Engineering (e.g., Chemical, Mechanical), or related field Minimum of 5 years experience in technical services, manufacturing, or process support role within the pharmaceutical or biopharmaceutical industry, with a strong focus on drug substance (DS) High level of technical expertise in DS manufacturing and associated unit operations Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing Proven experience supporting technology transfer, process validation, and continuous improvement activities Knowledge of upstream and downstream drug substance unit operations Knowledge of basic statistical principles and exposure to statistical software packages (e.g., Minitab, JMP) Exposure to project management principles and tools Experience with AI and AI-related tools for continuous improvement projects is desirable
Summary: Our client, a global biopharmaceutical company located in Cork, is seeking a CSA Construction Manager to join their Site Projects team. This role will support the delivery of multi-discipline capital projects, with a strong focus on Civil, Structural and Architectural (CSA) scope, within a regulated pharmaceutical/biopharmaceutical environment. The successful candidate will work as part of the on-site projects group, coordinating contractors and ensuring works are delivered safely, on schedule and within budget. Responsibilities: Manage CSA construction activities across multiple projects, from concept through to handover Coordinate contractor activities on site to monitor progress, track delivery against schedule, and manage cost control Support project engineering activities, ensuring CSA scope is aligned with project requirements and site standards Participate in constructability reviews, planning reviews, and safety reviews Review project scope, budget and schedule, highlighting risks and supporting mitigation planning Read and interpret construction documents including drawings, schedules, contracts, and proposals Support start-up, commissioning and turnover activities through to handover (where required) Ensure all construction activities are delivered in line with site Health & Safety requirements Support programming of work schedules and monitor building progress, compliance, and costs Manage workload across multiple projects of varying complexity, ensuring priorities are maintained Qualifications & Experience: Degree qualification in Engineering (Civil or related discipline preferred) 510+ years experience working in construction environments, ideally within pharmaceutical / biopharmaceutical or similarly regulated industries Proven experience in construction management, particularly within CSA scope Strong IT skills, with proficiency in MS Word, Excel (advanced), PowerPoint and MS Project
Summary: Our client, a biopharmaceutical company based in Cork, is seeking a Validation Engineer to support validation activities in a GxP regulated environment. The successful candidate will work within the Commissioning, Qualification and Validation (CQV) function and will be responsible for supporting the implementation of laboratory systems, new manufacturing equipment/processes, and changes to existing equipment/processes. Responsibilities: In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation programmes Execute validation activities (protocol generation, execution, and final package preparation) across various validation disciplines, including FUE Qualification, CSV, New Product Introductions and Change Control Develop validation plans for specific system implementation projects Support the establishment of site validation policies through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance Assist with preparation of regulatory filings and participation during regulatory inspections and partner audits Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured on site, validation techniques/approaches and systems utilised Lead and represent validation in multi-departmental meetings and project teams Identify and implement improvements to Engineering Validation systems Coordinate validation activities involving cross-functional, multi-departmental teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others Other duties as assigned Qualifications & Experience: Degree in Engineering, Science or a related discipline Experience working in a GxP regulated environment (biopharma, pharma, medical devices or similar) Hands-on experience supporting validation activities, including equipment qualification and/or process validation Experience generating and executing validation protocols and compiling final validation packages Working knowledge of change control, deviations, quality events and CAPA processes
Summary: Our client, a leading biopharmaceutical company based in Waterford, is seeking a Project Engineer with an Electrical background to deliver a diverse project portfolio. The successful candidate will be responsible for scheduling, planning, forecasting, resourcing, and managing all activities to ensure adherence to project schedule, cost, quality, and scope from conception to completion. Assigned projects will form part of a multi-million-euro portfolio and will require strong technical and electrical engineering input. Responsibilities: Deliver on biopharmaceutical equipment and electrical infrastructure projects onsite. Lead and support projects involving electrical services, automation systems, and process control upgrades, ensuring alignment with site and regulatory requirements. Perform procurement, commissioning, and acceptance of equipment and electrical systems on behalf of our client, reporting regularly on project status throughout the project lifecycle. Ensure compliance with environmental, health and safety codes, practices, and approved project KPIs, performance standards, and technical specifications. Liaise with internal and external customers, suppliers, and vendors to define and deliver right-first-time project deployment, particularly for electrical and instrumentation packages. Chair meetings and interact with assigned project teams to interpret their requirements and ensure approval to align project scope as requested. Assign responsibilities, mentor project team members, and maintain accurate project documentation as defined by the stage-gate model for project delivery. Provide clear communication through weekly reports to management and senior stakeholders. Support other project participants to overcome technical and operational obstacles. Review engineering deliverables, initiate site change controls, and manage associated documentation required by the project lifecycle. Deliver performance metrics for budget, schedule, scope, and quality adherence. Qualifications & Experience: Degree in Electrical Engineering or equivalent discipline. Postgraduate qualification (e.g. Masters in Engineering, Project Management, or related field) is an advantage. Minimum 5+ years experience in a project engineering or project management role within a regulated industry. Understanding of electrical distribution systems, control systems, instrumentation, and energy management. Experience working in a cGMP pharmaceutical or biopharmaceutical environment. Excellent knowledge of relevant electrical standards and safety legislation, including ATEX, IS, and IEC requirements, preferred. Proven ability to manage multiple projects simultaneously and deliver results to schedule and budget. Skills: Engineering Project Management Project Engineering
Summary: Our client is a global pharmaceutical company based in Dundalk looking for a CQV Engineer to provide project engineering services in support of the commissioning and qualification of a drug substance and drug product manufacturing facility. The successful candidate will work within the Global Engineering Team to act as client representative to deliver integrated project engineering services to meet the project objectives. Responsibilities: Preparation of project related deliverables such as schedules, work plans, equipment cost tracking Coordination of project activities between stakeholders Manage installation / start-up / testing of key equipment systems through OQ completion. Interface with cross-functional team to ensure systems post-OQ (PQ, PPQ) readiness. Monitor costs and progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders. Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables. Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the companys network as required to support projects. Qualifications & Experience: Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Engineering. Minimum of 6 years post academic engineering experience in relevant aseptic/sterile processing design and start-up environment.
Summary: Our client is a global Biopharmaceutical company based in Athlone is currently looking for a Manufacturing Process Engineer who will be responsible for delivering production related GMP projects within its FillFinish facility. Responsibilities: Assisting team members as directed for existing Aseptic Filling Lines. Involvement/leading process improvement projects as directed. Practical problem solving and root case analysis. Process parameter monitoring and control, yield analysis. Follow through on actions logs, project milestones and presentations. Look for new innovative technologies. Build a deep understanding of process variables. Daily, weekly & monthly reporting of product and process metrics. Work with quality management systems, process change management, ISO, FMEA, riskassessment, standard work documents. Qualifications & Experience: Relevant engineering degree, NFQ Level 8 or higher. Ideally Chemical, Mechanical, Manufacturing or Materials. Knowledge of Six Sigma and lean systems is an advantage IT literacy will ideally include SQL databases and Minitab. Experience in pharmaceutical processes is an advantage, particularly with Aseptic Processing(Partswasher, Autoclaves) & Filling (RABs or Isolator technologies). Ability to examine data to grasp issues, draw conclusions, and solve problems. Ability to make informed and timely decisions that take into account the facts, goals, constraints,and risks associated. A team player with a can do, pro-active attitude and a passion for improvement.
