Summary: Our client is a biopharmaceutical company in Waterford looking for a Process Engineer who will supportmanufacturing and drive development and implementation of improvement initiatives in the fill finish manufacturing and development operations. Responsibilities: Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations Optimisation of manufacturing and development operations Identification & implementation of opportunities for improvements Assist in the implementation of capital projects Act as process lead for inspection development Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams. Implementation and monitoring of performance metrics. Lead cycle time reduction initiatives in conjunction with manufacturing teams Implementation of best practice Process development programme design / plant trials, execution and implementation Constantly seeking to challenge operational standards and driving continuous improvement. Maintain required quality documents in a current compliant state. Resource for Clinical supply provision projects Aseptic manufacture or oral dose manufacture context Design and execution of experimental programmes Operation of process laboratories Scale-up and technology transfer project role Liaison for Clinical supply provision projects Liaison for new formulation and product enhancement programmes Technical representative for assessment and development of process change control and regulatory submission proposals Technical support and trouble-shooting in support of manufacturing activities Support of process qualification and process validation activities as required Qualifications & Experience: Degree in Chemical, Industrial or equivalent Engineering discipline Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage 2 years + experience within Pharmaceutical Development and Manufacturing environment OEE/SMED/RCA/CI experience.Technical knowledge of aseptic manufacturing including lyophilisation considered an advantage Pharmaceutical product development project life-cycle Structured Problem-solving skills Statistical
Summary: We are seeking aConstruction Manager (Client Side) who will play a critical role in the successful delivery of a pharmaceutical site expansion and fit-out project. This role will ensure that all construction activities are executed safely, efficiently, and in full compliance with GMP, local regulations, and company standards. The Construction Manager will interface with client stakeholders, and contractor organisations to ensure all works are delivered to scope, on schedule, within budget, and to the highest quality standards. Responsibilities: Act as the primary on-site client representative, ensuring alignment between contractors, consultants, and internal stakeholders. Work collaboratively with the SHE team, Facilities, and Operations to minimize disruption to ongoing pharmaceutical production. Ensure construction works meet GMP, building regulations, and internal quality standards. Support validation and engineering teams with handover readiness documentation. Promote a strong safety culture on site, ensuring adherence to all EHS requirements and company policies. Review incident reports, conduct site safety walks, and ensure corrective actions are implemented promptly. Provide regular progress reports covering safety, quality, schedule, risk, and cost. Foster strong relationships with design consultants, contractors, and the client project team. Lead or participate in weekly progress and coordination meetings, escalating issues as required. Support handover to local site operations, including facilitating signoff by the client representatives. Qualifications & Experience: Degree in Construction Management, Engineering, Architecture, or a related discipline. 10+ years experience in construction management, preferably on pharmaceutical or biopharmaceutical sites. Proven experience delivering fit-out and infrastructure upgrade projects within a live GMP environment. Strong working knowledge of GMP, EHS legislation, and construction best practices. Proficiency in MS Word, Excel, PowerPoint, Teams, MSProject and SharePoint Excellent communication, coordination, and stakeholder management skills.
Summary: A Senior QA Specialist is required for a biopharmaceutical company based in Athlone. The incumbent will be responsible for delivery of quality assurance activities to ensure commercial and clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. Responsibilities: Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to sites manufacturing and product supply. Acts as quality point person, providing guidance and feedback on quality assurance issues. 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 Clinical and Commercial Operations groups. Provide advice on GxP within the site, with reference to guidelines and regulations. Support technology transfers and new product introductions. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required. Provide quality oversight of Validation activities for the site. Support QP batch release activities to maintain release schedule. Actively support audit readiness activities and regulatory agency and internal audits. Actively contributes to continuous improvement activities. Lead coordination of referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews. Actively engage in process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices. Conduct data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes. Support overall planning around quality training and guidance for internal / external stakeholders for area. Guide early-career team members around quality processes, related digital tools, and compliance requirements. Acts as delegate for QA management. Qualifications & Experience: Third level qualification e.g. B.Sc. in science/pharmacy. A minimum of 7 years relevant experience within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required. Direct experience of New Product Introduction 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. Experience with quality processes across multiple areas. Experience interpreting and guiding team members around principles and concepts of compliance management within a regulated environment. Experience troubleshooting issues across quality areas. Experience implementing newer digital tools and technologies related to QA reporting, documentation, and analysis. Good knowledge of relevant computer packages e.g. TrackWise or similar. High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
A leading pharmaceutical firm in East Cork seeks an experienced Lead CSA Project Engineer to manage Capital Projects within a live manufacturing environment. The ideal candidate will have over 10 years of experience in delivering CSA projects within regulated pharmaceutical or medical device environments. Responsibilities include leading CSA activities, ensuring compliance with safety standards, and managing design consultants. This role offers a unique opportunity to contribute to significant projects within a dynamic organization. #J-18808-Ljbffr
Summary Our client, a pharmaceutical company located in East Cork, is seeking a Lead CSA Project Engineer to support Capital Projects within a live manufacturing environment. The successful candidate will act as a subject matter expert in Civil, Structural, and Architectural engineering, managing design consultants, engaging contractors, and ensuring the delivery of projects through the design, construction, and handover phases. The ideal candidate will be an experienced CSA engineer with strong capital project delivery experience within regulated pharmaceutical or medical device environments. Responsibilities Act as the lead CSA Project Engineer and SME (Subject Matter Expert) for the site's Capital Projects department and its associated projects. Engage CSA contractors in line with the Capital Projects Sourcing, Project Controls and Contract Administration requirements. Engage with and manage design consultants to ensure they deliver and meet the client’s requirements. Responsible for reviewing and approving, when applicable, all CSA design documentation produced by design consultants in accordance with agreed scopes of work and key project milestones. Support Capital Projects to deliver projects on time and in accordance with agreed key milestones for a project or portfolio of projects for the site. Communicate the CSA status of all projects to all relevant stakeholders and shall provide updates on CSA aspects for Capital Projects to Key Stakeholders for a project and portfolio of projects. Ensure that each completed project meets local codes, regulations, and quality standards. Mentor Capital project engineers on best practices in CSA building design and execution. Ensure compliance with agreed construction methods, particularly those relating to Quality Assurance and Environment, Health & Safety. Responsible for the coordination of CSA work packages, specifically ensuring the smooth transition from design to construction to handover to operations in a live operational environment. Responsible for the inspection of on-site construction works relating to projects, to ensure compliance with design requirements and building and planning regulations. Assess any potential safety hazards on site whilst continually focusing on ways and methods to eliminate and/o mitigate risk throughout the lifecycle of a project. Responsible for liaising with the site Construction Management team to ensure construction meets all design criteria. Responsible for acting as the site Point of contact / SME for Planning applications and associated work package. Qualifications & Experience Engineering qualification with 10 plus years’ experience delivering CSA capital projects within pharmaceutical or medical device manufacturing environments Professional registration desirable (e.g. Engineers Ireland or equivalent) Proven experience delivering projects in multi-disciplinary teams against key milestones and budgets Experience developing, implementing and improving capital project processes and procedures Strong IT skills, including MS Office and MS Project Experience creating project schedules across design, construction, commissioning, qualification and handover phases Experience managing suppliers, including design, construction, equipment and professional services vendors Understanding of quality, health, safety and environmental requirements for construction in regulated industry environments Experience in planning, building control and fire certification processes Experience with construction materials and methodologies suitable for pharma / med-device environments Experience with design software such as AutoCAD or Revit is desirable Experience in value engineering and capital sourcing processes is preferred Experience interpreting tender documents, specifications, and drawings is a plus #J-18808-Ljbffr
Summary: Our client, a pharmaceutical manufacturing company located in North Wicklow, is seeking a Project Manager to lead end-to-end delivery of medium to large-scale processing equipment and facility projects. This role manages full lifecycle project activities, including scope definition, design, procurement, installation, commissioning and handover. The successful candidate will support new product introduction projects, process equipment upgrades, and utility modifications within a GMP environment. Responsibilities: Lead full lifecycle project management for processing equipment and associated utilities, from concept through to handover. Ensure projects are delivered safely, on time, within budget and in line with GMP and engineering standards. Oversee development of project documentation, including design packages, schedules, budgets, procurement plans and progress reports. Coordinate cross-functional teams including Engineering, Operations, Quality, EHS, Procurement and external partners. Manage equipment specification, vendor selection, factory and site acceptance, installation and qualification activities. Support preparation of business cases and capital applications. Drive structured problem-solving and risk mitigation throughout project execution. Ensure compliance with quality systems, change management processes and safety requirements. Provide on-site oversight during installation and commissioning, ensuring adherence to design intent and operational needs. Support training and transition of new systems to end users. Qualifications & Experience: Bachelors degree in Engineering, Science or related technical discipline. Minimum 10 years experience delivering capital projects in pharmaceutical or biotech manufacturing. Proven experience managing equipment and facility projects up to approximately €3M. Strong understanding of GMP, engineering design, equipment installation and commissioning. Experience managing external contractors and equipment vendors. Strong communication, leadership and stakeholder engagement skills. Experience in scheduling, cost estimation and project controls. Project management certification (PMP/IPMA) is an advantage.
Summary: We currently have an opportunity for an Electrical Engineer to join our team. The successful candidate will support a variety of projects in the pharmaceutical, biopharmaceutical and medical device industries. Responsibilities: Delivery of projects including detailed design, scope issue, field construction and commissioning through to handover. Will be involved in the preparation of cost estimates for clients including timelines and justifications. Carry out site surveys. Carry out the design of areas such as lighting, small power, fire alarms, LV distribution and cable sizing etc. Assist with the preparation of projects schedules and monitor progress, ensuring critical path is maintained and implementing mitigation plans as necessary. Help develop a strong safety culture within the company, proactively drive towards continuous improvement and achieving best in class standards. Generate User Requirements Specifications with stakeholders. Review design packages from consultants. Involvement in the issuing of tender enquiries for consultants, contractors and vendors. Interface with project management and project engineers during the design, execution and start-up phase of projects. Support field installation and commissioning of larger projects. Qualifications & Experience: Degree in Electrical Engineering or similar. Minimum 3 years post graduate experience in project delivery in a medical device or pharmaceutical manufacturing environment. Working knowledge of CAD a distinct advantage. Technical knowledge of MV and LV power infrastructure, Building Management Systems (BMS), data and IT infrastructure. Project planning, design, cost control. Ability to coordinate of multiple stakeholders, contractors and vendors.
Summary: Our client, a pharmaceutical manufacturing company located in North Wicklow, is seeking a Project Manager to support packaging equipment upgrades, asset care initiatives and new product introduction activities within a pharmaceutical packaging environment. The role includes leading full lifecycle delivery of packaging-related capital projects and ensuring compliance with GMP, engineering and safety standards. Responsibilities: Manage all phases of packaging equipment projects, including concept development, basic and detailed design, procurement, installation, commissioning and qualification. Deliver high-speed packaging line upgrades, format part changes and general asset care improvements. Ensure adherence to project scope, schedule and budget while maintaining compliance with GMP, engineering and safety requirements. Coordinate the activities of internal stakeholders and external suppliers across packaging, engineering, quality and operations. Prepare and maintain project documentation including project plans, technical specifications, risk assessments and status reports. Lead risk management activities and facilitate issue resolution across project teams. Support capital approval processes and development of project justification packages. Oversee CQV activities and ensure readiness for operational handover and training. Ensure compliance with site quality systems, procurement governance and safety procedures. Qualifications & Experience: Bachelors degree in Engineering, Science or a related technical field. Minimum 10 years experience managing packaging or equipment-related capital projects in pharmaceutical manufacturing. Experience delivering full lifecycle equipment projects up to approximately €3M. Strong knowledge of packaging processes, automation interfaces and equipment design documentation. Experience working with equipment vendors and contract engineers. Proficiency in project planning, scheduling and cost control. Strong stakeholder engagement, communication and problem-solving skills. Project management certification (PMP/IPMA) is an advantage.
Summary: Our client, a leading biopharmaceutical company located in Louth, is seeking a DP Engineer Formulation to provide technical leadership within a new Drug Product manufacturing facility. The successful candidate will support the introduction, operation and optimisation of formulation equipment and processes, ensuring all systems are safe, compliant and operating in line with industry standards. The role involves equipment readiness, troubleshooting, continuous improvement, change management, and maintaining the validated state of all relevant systems. Responsibilities: Provide technical leadership for formulation equipment and processes within the Drug Product manufacturing area. Ensure all equipment installed is safe, effective and compliant with applicable standards and engineering procedures. Support the development, review and execution of testing protocols, reports and manufacturing documentation. Prepare and execute cGMP documentation, including risk assessments and associated reports. Manage equipment vendors, including oversight of maintenance activities, continuous improvement projects and spare part criticality assessments. Maintain validated equipment status by executing revalidation protocols in alignment with the site Validation Master Plan. Troubleshoot equipment and process issues, collaborating with cross-functional teams to implement effective corrective and preventive actions. Apply structured problem-solving and continuous improvement tools such as DMAIC and FMEA to drive operational excellence. Manage equipment or process changes through the site change control system. Contribute to establishing a new Preventive Maintenance (PM) programme for Drug Product equipment. Lead and support technical investigations, ensuring root cause analysis, impact assessment and appropriate CAPA implementation. Identify opportunities for process and equipment optimisation and translate these into CI initiatives. Support batch disposition by resolving technical or engineering issues encountered during processing. Participate in TPM, CI and Gemba activities, and engage in daily and weekly tiered manufacturing meetings. Provide technical support during regulatory inspections, defending systems, investigations, validations and change controls as needed. Assist in the transition from project start-up to sustained manufacturing operations, supporting scale-up and long-term equipment reliability. Qualifications & Experience: Bachelors degree in Engineering, Science or a related technical discipline. Minimum 5 years engineering experience in a cGMP manufacturing environment. Experience executing FAT, SAT, IQ and OQ in an operational setting. Strong background in structured problem solving and CI methodologies (e.g., Six Sigma). Demonstrated experience resolving complex technical investigations. Knowledge and application of risk-based tools such as FMEA. Experience with autoclaves, parts washers and CIP/SIP systems. Knowledge of formulation processes and associated equipment. Experience working in start-up facilities is an advantage. CQV experience is desirable. Familiarity with regulatory frameworks such as Annex 1 is beneficial.
Summary: Our client, a pharmaceutical manufacturing company located in West Dublin, is seeking an experienced Project Manager with strong automation and control systems experience to lead and deliver multiple automation and digital integration projects. The successful candidate will manage full project lifecycle activities including feasibility, design, vendor coordination, implementation, commissioning, qualification, and handover. Responsibilities: Lead end-to-end project management for automation and digital integration initiatives, ensuring delivery to scope, schedule, budget and quality requirements. Plan, coordinate and execute key upcoming projects, including: Installation and commissioning of an offline DCS system for training and validation use; Upgrades to DCS software applications and associated OT network infrastructure; Replacement and lifecycle upgrades of legacy and obsolete control systems. Serve as the primary point of contact for automation, IT/OT and control system vendors; manage scope, deliverables, change control and vendor performance. Drive integration between plant automation platforms and manufacturing OT/IT systems to support data integrity, system monitoring and asset lifecycle management. Develop and maintain all project documentation across the lifecycle, including feasibility studies, URS, functional/design specifications, schedules and project plans. Prepare RFP packages, coordinate vendor queries, perform technical and commercial bid evaluations, and recommend preferred solutions. Lead project risk assessment activities and implement mitigation strategies covering cost, schedule, technical and compliance risks. Support capital approval processes including business case development, cost estimates and risk assessments. Coordinate cross-functional project teams and ensure alignment with Operations, Engineering, Quality, IT/OT, EHS and other stakeholders. Chair project meetings, manage action lists and ensure timely closure of actions. Oversee FAT/SAT, detailed design, commissioning and qualification activities for automation and control systems. Ensure controlled execution of shutdowns, tie-ins and cutovers to minimise operational impact. Support testing and validation deliverables including test plans and IQ/OQ/PQ, in accordance with current regulatory expectations. Ensure all project activities comply with GMP, data integrity principles, and manufacturing quality systems. Coordinate training, knowledge transfer and system handover to Automation, Operations, Maintenance and IT/OT support teams. Provide regular project status reporting to stakeholders, highlighting progress, risks and issues. Ensure adherence to EHS requirements and participate in cross-functional training initiatives. Qualifications & Experience: Bachelors degree in Engineering or a related technical field (e.g., Electrical, Automation, Mechanical, Chemical, Control Systems or Software Engineering). Minimum 5 years experience as a Project Manager or Project Engineer within a regulated pharmaceutical or biopharmaceutical manufacturing environment. Strong experience managing the full lifecycle of automation or digital integration projects, including feasibility, design, risk management, vendor selection, implementation and handover. Good understanding of automation and control systems, ideally with experience in one or more of the following: DCS/PCS/SCADA platforms; Control system architectures, OT network structures and integration with manufacturing/business systems; HMI, thin client or user interface technologies; OT network infrastructure, cybersecurity and patching strategies; Industrial communication protocols and data integration concepts. Familiarity with data integrity principles and regulatory requirements such as 21 CFR Part 11 and Annex 11. Experience planning and executing lifecycle upgrades and replacement of legacy control systems. Demonstrated ability to manage multiple concurrent projects in a dynamic manufacturing environment. Ability to work on-site full-time as required by operational needs.
