Summary: Our client is a biopharmaceutical company based in Dublin looking for a Process SME to lead the design of process, technology, associated inputs and associated ancillary processes for clean utilities for the project Basis of Design and detailed design. Responsibilities: Take technical ownership for all aspects of the design that impacts on the operation of the facility and collaborate with all disciplines to ensure requirements are understood and delivered. Ensure manufacturing network alignment for process assumptions, including but not limited to mass balances, manufacturing processes and technology, and process/facility control alignment. Review and approve facility controls/design elements that may impact process development or control strategy within relevant scope Provide technical direction and leadership within the technology area. Engage with key stakeholders to ensure that their needs are understood and reflected in the design. Prepare Project Technical Requirements Specification for all systems specifying performance requirements & applicable to the Companys Standards Ensure all relevant company specifications are provided to the Design Contractor. Define & agree with Design Contractor necessary design deliverables for all design stages (CD, BD, etc.) - Design Deliverables List made Project Specific including the level of review appropriate to these documents. Review Contractor response to the Project Technical Requirements to ensure the companys requirements are correctly included. Attend Project meetings on an as required basis. Ensure User Requirement Specification (URSs) are produced and are complete (CTQs, GMP, GEP and SHE requirements), technically correct and appropriate for C&Q execution. Participate in and make recommendations for the procurement strategy for technical work packages including pre-qualification/contractor selection and technical content/scope of contracts. Produce regular Design Assurance Reports?according to the plan set up by the PTM,?to ensure ongoing technical alignment. Identify value engineering opportunities. Ensure key SHE and GMP compliance requirements are reflected in the design deliverables.? Attend and contribute to SHE?risk?assessment activities to ensure alignment with the companys SHE requirements and ensure appropriate mitigations are included in the design. Provide technical guidance to Work Package Owner teams within their areas of responsibility. Ensure specific technical solutions are consistent with Customer, cost and schedule requirements. Provide input to Project Planning. Review / involvement with mechanical packages. Support development of redundancy strategy and maintenance philosophy. Review & input to Sustainability Checklist. Respond to Construction queries where the Design Contractor is unable to provide answers. Answer Design Contractor queries as required. Review Design Contractor enquiry specifications for specific items (define which) and involvement in the bid review / selection for these systems. Review a sample of documentation (drawings & calculations) for each area to ensure correct interpretation of AZ Requirements. Qualifications & Experience: Degree in Chemical or Process Engineering. 15+ years in a design role within the pharmaceutical sector Bulk Drug Substance Experience is required Biologics experience is a distinct advantage. Ability to create and maintain effective working relationships and willing to challenge behaviours and actions. Demonstrated practitioner of practical problem-solving. Detail focused completer/finisher with a results-orientated mindset. Strong leadership qualities with motivational ability to direct others in a dynamic and complex environment through change. High profession standards, holding themselves and other in the team to deliver high quality outcomes to committed deadlines.
Summary: A Senior Project Scheduler is required to support a multimillion project within a biopharmaceutical company in West Dublin. The successful candidate will be responsible for creating and managing the integrated project schedule. Responsibilities: Create the integrated schedule management plan specific to the project situation and needs. Develop an approach for the use of benchmarking that includes the involvement of Global Planning Lead. Work with third parties who are requested to prepare schedules to ensure they have the companys standards and information required to complete the work in line with expectations. Review third party schedules, reconcile, and integrate into the master schedule. Prepare the schedule basis, review and agree it with the project team. Create the integrated project schedule, applying the companys global engineering and reliability excellence work breakdown structure. Follow standards, requirements, and expectations for the stage. Facilitate interactive planning session to assist with the schedule build. Manage workshops to capture the full integrated project schedule across design, construction, mechanical completion process, commissioning, qualification and validation, and operational readiness. Develop, agree, and implement an approach for analysing risk and establishing and controlling schedule contingency. Execute schedule review and verification processes at varying intervals throughout the project life cycle to help maintain expected schedule quality and integrity. Prepare the schedule for approval by the project manager and project controls function. Escalate significant issues where there is no alignment within the project team, to ensure resolution. Qualifications & Experience: Bachelor degree in a relevant engineering discipline. Minimum of 8 years relevant experience in project scheduling or project controls. Experience in biologics and new product introduction (NPI) projects is highly desirable. Proficient user of Primavera P6 or Microsoft Project is essential. Strong understanding of project management principles, construction management, and estimating processes. Experience working with trade partners, contractors, and cross-functional project teams. Demonstrated ability to develop, manage, and integrate complex project schedules in a multidisciplinary environment. Experience working within Good Manufacturing Practice (GMP) environments or regulated industries (e.g. pharmaceutical, biotechnology). Skills: Primavera P6 Project Control MS Project
Summary: Our client is a global pharmaceutical company based in Dublin looking for a Process Design SME to lead the hydrogenation process design through to completion/FAT/installation/start-up and continuous processing train for installation/start-up Responsibilities: Understand business objectives, project scope, schedule, and critical success factors. Understand and engage project stakeholders relevant to SME role. Participate in the capital project team through all phases of the project; these phases include project proposal/charter, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, reviews P&IDs, validation, and qualification. Assess equipment needs and support the generation of equipment URS and specifications for design or purchase. Understand project remit in terms of scope of work and interfaces with other SMEs scope of works. Ensure requirements are appropriately documented and agreed with project stakeholders. All GMP URSs to be documented and agreed with project stakeholders in basic design. Work collaboratively with project stakeholders, including collaboration between other packages and disciplines Ensure requirements are understood and included in the scope of works of designer. Proactive engagement with designer to ensure design is being developed in line with requirements. Produce agreed project deliverables in accordance with project schedule deadlines. Support work package owners in understanding requirements and design basis and in planning and delivery of work packages Support procurement activities, as required. Consult on work package breakdown and scope of works. Participation in project meetings, design meetings, SME meetings, and project tier meetings, as agreed with Technical Manager. Raise issues and escalate through agreed project processes Input into project risk register and project/work package cost/schedule reviews. Responsible for design assurance reviews for assigned technical packages. Consulted on C&Q plan Input into SHE risk assessments and Engineering Compliance tracker Reporting of progress, issues, and escalations Review design deliverables to validate that they meet requirements, including design qualification for GMP packages Support the Technical Manager in preparation for Engineering Council Prepare requirements for Detailed Design Participate in project learning reviews Support work package owner in monitoring progress, planning installation/commissioning/qualification activities, and responding to technical queries. Prepare and participate in pre-FAT inspections as per C&Q plan Prepare and participate in FAT as per C&Q strategy and plan Support IQ, OQ, PQ as per C&Q strategy and plan (prepare, review, approve IQP/IPR, OQP, OQR, execute test/witness tests as per agreed plan) Consulted on pre-start up safety review. Prepare and participate in construction inspections/walk downs, as required. Prepare for and participate in construction acceptance, as required. Prepare for and participate in commissioning testing, as required. Participate in project learning reviews. Qualifications & Experience: Degree in Chemical or Process Engineering Project Management Certification an advantage Minimum 15 years experience on pharmaceutical design projects Experience in API a distinct advantage Proven project design delivery
Summary: Our client is a pharmaceutical company based in East Cork looking for a Project Engineer to support Equipment Upgrades in their Tablet Manufacturing Operations. Responsibilities: Will be responsible for equipment introductions to the Manufacturing Operations facility. Managing and executing projects throughout project life cycle from initiation to closeout. Completion of Front End studies with end-users for projects to determine most appropriate technical solution for the request at hand and develop business cases, budgets and schedules to support CAPEX funding applications. Manage and execute design, procurement, construction, commissioning and qualification phases of the project. Manage cross-functional client project teams. Project scheduling & cost control with regular reporting to key client stakeholders. Manage project changes and ensure all are captured, documented and assessed. Ensure there is a strong safety culture and performance in the execution of capital projects. Project validation execution. Qualifications & Experience: Degree in a relevant science / engineering discipline. 5+ years of project management/engineering experience across the project life-cycle within a Pharmaceutical environment. Experience in Tablet Press/Compression/Coating Equipment an advantage. Candidates to have a solid background in delivering Process Equipment projects with a chemical engineering background. Experience in working in client-side Capital Projects execution role. Experience in Client Electronic Change Management Systems & full end-to-end Project Life-cycle. Experience in managing cross functional teams and projects in a GMP Manufacturing Environment. Understanding of Environmental, Health and Safety requirements of the Pharmaceutical industry. Strong understanding of the principles of current Good Manufacturing Practices (cGMP). Understands the project management process; programming, scope development, design development, implementation, and project closeout.
Summary: Our client is looking to hire a Project Manager who has previous relevant experience to provide client side design input at the Basis of Design, Detailed Design, Commissioning, Qualification and handover stages of a design project for a Laboratory / Canteen expansion in a live Pharmaceutical facility. The scope of the role, may also include design input and support, as requested by the Design Manager, to various ancillary scopes of the project, such as the Fill/Finish Facility, the existing Warehouse, general site infrastructure and a new Multistorey Carpark, which are all collectively managed as part of the project. The position is a hybrid position with an on-site (3 Days minimum) and remote working element. As the project progresses to execution phase, the requirement will be to support the project on site on a full time basis to support construction execution activities. Responsibilities: To support client side design team in its efforts associated with the design of the Laboratory reconfiguration and the existing Canteen expansion To coordinate client side design activities by liaising with the Companys Design Team Resources, Site SMEs and Clients Engineering Technical Authority (ETA) in delivering the Canteen and Laboratory designs. To lead the client side design reviews and to coordinate the participation of all stakeholders. To coordinate and participate in cross functional package, area, or overall design team reviews as required in support of clients overall design goals and expectations To support site facility and utility walkdowns by the Third-Party designers and to schedule such activities with site Facilities Group, Engineering and the Laboratory End-User. To act as a point of contact for all technical queries in relation to assigned scopes of work To generate, in conjunction with A&E Designers and End-Users, the project execution schedule to a level 3 detail. To coordinate with Site Facilities, Engineering and End Users in relation to the Site Engineering Change Management process. To liaise with C&Q, in support of the commissioning / qualification of the Laboratory and Canteen systems. To support the handover process of the systems / facilities to Engineering and Laboratory End-Users. Qualifications and Experience: Degree level qualification in Mechanical, Electrical Engineering, CSA background, or similar/equivalent. Minimum of 10 years of experience in pharmaceutical Facility, Laboratory and/or Canteen design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design. Previous experience of laboratory, or similar, renovations, and/or refit in a live working environment, including coordination with end-users. Particular relevance would be previous experience in Laboratory retrofits and Canteen Expansions Ability to challenge, defend and present technical aspects of design and commissioning.
Summary: Tandem is an expert engineering consultancy delivering project success to clients in life sciences, commercial, industrial, high tech & public sectors. We are looking for a Project Scheduler to join our team in Cork. The candidate will develop and manage schedules to support the successful execution projects. Responsibilities: Ensure planning/scheduling, managing and controlling elements of a portfolio of projects. Establish and implement project control execution plans in respect of schedules. Responsible for forecasting, progress measurement/schedule status, change management, risk management, and early warning of issues. Develop and maintain overall project end to end schedules. Support interactive planning sessions for project schedules. Monitor leading indicators and trends to provide early warning of issues to project teams. Collaborate with teams to solve any issues that may arise. Focus on control and continuous improvement. Understanding and implementation of Change Management and Schedule Risk Management. Qualifications & Experience: Bachelor Degree in relevant engineering discipline. 3+ years applicable project control related experience. Proficient user of Primavera / P6 is a distinct advantage. Working knowledge of project cost and financial management. Experience in lean project delivery methodologies. Project Management, Construction Management and/or Estimating experience and Trade Partner experience would be helpful.
Summary: Our client is a Biopharmaceutical company based in South Dublin, looking for a Project Manager. The successful candidate will support the current expansion projects being executed on site through design, build/install, CQV to handover to operations. The suitable person will typically have prior related project engineering experience ideally in the pharmaceutical industry. Responsibilities: Project execution will focus on safety, schedule, and budget adherence while complying with good engineering practices, company policies, regulations and codes. Accountable for meeting key project deliverables for, equipment management and turnover management across the projects. Accountable for ensuring projects are compliant with good engineering practices, company policies, regulations and codes. Liaise with Engineering/EHS/Procurement to ensure all are aligned and support project deliverables. Planning and Scheduling, uses planning tools to hold a complex project on schedule and coordinate parallel activities. Coordinate with facilities, EHS, QA, etc. Risk Management, identifies and categorizes project risks according to impact on scope, budget and schedule. Generates action plans to mitigate risks. Manage EPCM during design, FATs and delivery to site for all small scale equipment from award. Coordinate with CMT to align on equipment installation requirements. Coordinate client support for Mechanical Completion and Turnover process. Collate all equipment and trade information to support engineering deliverables. Manage start-up of all equipment and systems through to handover to Operations. Manage and execute the operational readiness phase of each building to ensure on time handover of operations to end users. Presentations and reporting out on progress of projects to stakeholder as required. Coordinate engineering, EHS and CQV support to support handover of buildings Complete Project Close-out as per Stage Gate process. Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities. May be required to perform other duties as assigned. Qualifications & Experience: A degree in Chemical/Mechanical/Process Engineering. 5 years+ in a similar role. Demonstrable skills that can be applied to effectively manage and execute projects from design to completion. Familiar with project life-cycle process. Demonstrated understanding of the project management process, scheduling, design development, implementation, project closeout. Experience of executing and/or managing equipment and process design through to construction. Demonstrated experience and ability to effectively manage stakeholders. Excellent communication skills and the ability to influence others. Strong computer MS Office skills (PP, Word, Excel, Project etc.). Demonstrable people management skills or experience working with cross functional project teams. Proactive and accountable person with a demonstrable willingness to learn. Demonstrable experience of managing a cross functional team to deliver projects is desirable. Turnover experience is desirable.
Summary: Our client, a biopharmaceutical company located in Dublin, is seeking an Indirect Tax Senior Specialist to join their team. The ideal candidate will assist the Global Indirect Tax Compliance leads and support the various Indirect Tax activities of the company. This will involve managing the efforts to ensure that the organisation is compliant with all local and regional Indirect Tax laws, all filings are accurate and correct, that all processes are documented, and all Indirect Tax matters are resolved timely, thereby reducing the tax burden on the organization. The successful candidate will demonstrate Indirect Tax advisory knowledge, analytical abilities, communication skills, and will be responsible for assisting in various facets of the Global Indirect Tax process, including master data analysis, transactional inputs, system design, and controls. Responsibilities: Reviewing outsourced or in-house Indirect Tax returns for multiple EMEA jurisdictions. Act as key liaison between Indirect Tax and non-tax partners within the company to raise VAT compliance profile. Actively monitor tax processes and systems to ensure that they are efficient, accurate, up to date and comply with current regulatory requirements. Identify and communicate opportunities to achieve end to end process improvements and coordinate / lead implementation as needed. Keep abreast of changes to Indirect Tax legislation and potential impact on the company and effectively communicate these changes to relevant colleagues and stakeholders. Qualifications & Experience: Qualification(s) in Accounting, Finance or similar. Minimum of 5 years of experience in a multinational Tax dept. or similar environment. Strong understanding of EU VAT Directive and application of same at local Member State level. At least part qualified CTA, ACCA, CPA or other VAT specific qualification(s). Fluent English required, other language(s) possibly an advantage. Intermediate to advanced Microsoft Office all applications. SAP ERP (also Ariba, Concur) experience desired with tax determination experience and understanding an advantage.
Summary: Our client is a multinational pharmaceutical company with an exciting opportunity for a Mechanical Engineer to join their Site Projects Group in South Tipperary. As the successful candidate, you will support various projects. Responsibilities: Develop and manage preventative maintenance schedules, ensuring vendor Service Level Agreements (SLAs) are in place and performance is monitored. Ensure availability and inventory control of critical spare parts to support uninterrupted facility operations. Lead the registration and accurate documentation of Equipment and Instrumentation within the sites Computerised Maintenance Management System (CMMS). Participate in and coordinate Factory Acceptance Tests (FATs), project walkdowns, commissioning activities, and final documentation handover to ensure readiness for production. Author and implement Standard Operating Procedures (SOPs) and Work Instructions (WIs) to support facility and equipment operations. Drive and support equipment validation activities, with particular focus on HVAC systems and Process Air utilities, ensuring compliance with regulatory standards. Monitor and report on engineering performance metrics, developing and executing corrective action plans to address gaps. Champion continuous improvement initiatives through Digital Transformation projects and Manufacturing Production System (MPS) tools, including Tier reviews, 8-Step Problem Solving, and process standardisation. Qualifications & Experience: Degree qualified in Mechanical engineering. 1+ year working relevant experience. Experience of working in strongly regulated GMP environment would be ideal. Understands the typical project life cycle from concept through to qualification and has proven experience in this area. Familiar with engineering project management tools, financial management skills including an ability to work within budgets and engineering technical skills. Excellent oral and written communication skills. Ability to respond to changing priorities.
Summary: Our client, a biopharmaceutical company located in Dublin, is seeking an Accounting Manager to join their team. The ideal candidate will have experience in applying accepted accounting principles and procedures to analyse financial information, prepare accurate and timely results and to ensure appropriate account control procedures. The successful candidate will be a member of a cross-functional, multi-national, accounting team responsible for critical accounting areas, staff management, business support, and ad hoc reporting. Responsibilities: Responsible for monthly, quarterly, and annual corporate reporting under US GAAP (including account analysis & reconciliation and preparing inputs to month end reports including financial analysis & commentary). Responsible for annual financial reporting to local statutory authorities under IFRS and local GAAP. Reconciliation between US GAAP and local GAAP accounting. Detailed analytical review of financial data and presenting to senior leadership on the financial performance of the entities. Review entity profitability monthly to understand deviations and support Global Transfer Pricing team as required. Partnering with Financial Planning & Analysis and the business to ensure correct goods receipting, substantiate accruals and to action any findings from accrual analytics. Management of the yearend financial statement audits, working to key deadline targets and reporting of progress to the co-ordination team. Liaising with the Tax Team to support the corporate tax filing process. Supporting the SOX audit process as required. Manage relationships with outsourced providers as required (including auditors and outsourced accounting providers). Development and management of direct reports and mentoring other members of the team. Identify opportunities for continuous process improvements and innovative solutions so the team can operate in an efficient manner, in BioMarin we aim to work collaboratively sharing ideas and supporting each other as necessary. Work closely with Finance colleagues both locally and globally, adhering to global deadlines. Support project and continuous improvement tasks as required. Assist with ad hoc financial analysis, queries and activities as required. Qualifications & Experience: Fully Qualified Accountant (ACA or ACCA preferred). Minimum five years relevant experience in similar role is essential. Knowledge of both US GAAP and IFRS is advantageous. Familiarity with Sarbanes Oxley and internal controls is desirable. Experienced in SAP S4 Hana in addition to an understanding of Oracle & Hyperion. Strong technical accounting skills.
