Program Manager - Pharmaceuticals - County Sligo Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Project Manager to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. Responsibilities: Coordinate site project team to deliver Biological projects. Develop realistic cross functional implementation plans with input from above site and site functions (R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial, Supply Chain, Finance, HR). Utilise the relevant PMO tools for project planning, monitoring and reporting. Set project milestone and report progress accordingly. Consider alternative approaches and take corrective actions as needed to ensure project milestones are achieved. Provide program management support for and guide the efforts of third-party organisations (vendors, suppliers, contractors, etc.) to enable achievement of shared milestones. Lead project teams to ensure efficient communication between resources. Engage with all stakeholders to ensure full alignment on priorities and proactively manage and report project risks. Work with cross functional teams to develop required change plans and raise/track change plans in the appropriate systems. Accountable for managing the project timeline and reporting any potential delay/risk on the critical path. Requirements: Essential Requirements Degree in Engineering, Science business, Project management or related discipline PMI certification is desirable Desired Requirements Program Management experience. Ops experience in Sterile Manufacturing If this role is of interest to you, please apply now! #J-18808-Ljbffr
Maintenance Planner - Biotechnology - Waterford - 12-Month Contract Our client, a globally recognised pioneer in Biotechnology, is recruiting for the position of Maintenance Planner. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions. This is your chance to join them on their global mission to better the lives of those affected by disease and illness. Responsibilities: Ensure maximum equipment and systems reliability & performance is achieved. Continuously plan and promote a positive safety culture. Ensure all team’s work is carried out in compliance with the required standards, conforming to company, cGMP, SOP’s and regulatory guidelines. Ensure new assets are registered on the site CMMS system (PEMAC) and integrated into the Asset Care Schedule of PM and Calibration Routines. Key Requirements: Min Level 7 Engineering degree in Mechanical or Electrical or equivalent training/experience. Few years’ experience working in a similar maintenance/reliability engineering role within pharmaceutical/biotech industry. Mechanical background desirable. Fill/Finish environment experience is beneficial. Strong teamworking skills and stakeholder management experience. Strong CMMS system experience (MAXIMO and PEMAC desirable). Excellent written and verbal communication skills. If this role is of interest to you, please apply now! #J-18808-Ljbffr
Automation Engineer - Westport, County Mayo Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for an Automation Engineer to join their state of the art pharmaceutical facility. Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, this area breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants, and water sports. Responsibilities: Primary responsibility is to support the business Unit / Department with day-to-day automation issues to ensure successful delivery of the planned production schedule. The role will be based on 2 nd shift (16:30 – 00:00) @ 20% or 3 rd shift (00:00am to 08:00) @ 33%, with cover support for weekend callouts. Implement improvements to the equipment and procedures used in the manufacturing process. Lead small automation projects to improve the processes within the unit. Support the automation design element of capital expenditure projects in the unit/department. Support the installation and commissioning of automated equipment onsite. Contribute in a team environment on specific technical problem-solving forums associated with product manufacture, aseptic fill, and packaging. Work closely with the BTS (IT) and Maintenance groups when troubleshooting issues on equipment and systems. Support off shift and weekend issues as required based on a Rota. Requirements: Bachelor’s degree required in Engineering, I.T, Mechatronics or other related discipline. Minimum 1-3 years’ experience working on support automation control systems and client/server architectures with a strong grasp of basic networking concepts. Experience working with Siemens and Rockwell (Allen Bradley) PLC control systems. Experience working with SCADA systems, Rockwell FactoryTalk, Siemens WinCC, iFix, Wonderware, etc. If this role is of interest to you, please apply now! #J-18808-Ljbffr
QC Material Management - Dublin, Ireland - 12-Month Contract Our client is seeking to recruit a QC Material Management Analyst to join the QC Site Operations team at its Multi-Product Cell Culture Drug Substance Facility in Dublin. Reporting to the QC Material Management Supervisor, they will be responsible for supporting site activities related to the Sample Management/Buffer Preparation Laboratory, in-process samples, and laboratory duties in accordance with cGMP regulations. The main responsibilities for this position include: Liaise with manufacturing to ensure all Drug Substance samples are processed and delivered to the appropriate destination in an appropriate timeframe. Liaise with Engineering Stores to ensure all Drug Product samples are processed and delivered to the appropriate destination in an appropriate timeframe. Liaise with Warehouse Cryogenics Logistics (WCL) to ensure all Raw Material samples are processed and delivered to the appropriate destination in an appropriate timeframe. Manage TempTales and shipping documents when receiving samples from external sites. Log in of samples to LIMS/CIMS or logbooks, and label accordingly. Release samples for QC testing. Storage of backups and reserve samples. Perform monthly reconciliation and report deviations to Sample Management Lead, if any. Aliquot samples for the QC activities for Global Biologics Laboratory and Multi Product Cell Culture (MPCC) Facility. Buffer preparation activities for the QC Laboratories. Generate and update SOPs and other relevant documents as required. Maintain a high standard of GMP compliance including the completion and provision of training as required. Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing. Performing any other activities as indicated by the Lab Supervisor. If this role is of interest to you, please apply now! #LI-JS4 #J-18808-Ljbffr
CQV Clean Utilities - Pharmaceuticals - Dublin Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for a Clean Utilities to work on an exciting CapEx project in Dublin on an initial 9 month contract. As a CQV Clean Utilities you will play a key role in the successful delivery of a new state of the art facility. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Plan and lead team of engineers in commissioning and qualification clean utilities. Participate in design document reviews and ensure that quality aspects are included in design. Attend FAT and execution of agreed testing protocols and sign off on permission to ship forms. Generate CQV documents at project level and for specific equipment/systems. Liaising with Quality, Engineering and CQV to align on Critical parameters and document content. Work with the automation teams, ensure that process descriptions are provided, and Functional Specs are reviewed and approved to ensure that the automation element of the project meets schedule. Track and confirm closure of actions items identified through FAT, HAZOP, Design Qualification and other reviews. Maintain a strong interface with the Automation and Engineering teams to ensure that the information flow meets the needs of the Automation and Engineering teams, resolving issues as they arise. Participate in construction system completion walkdowns. Perform shakedown and commissioning and qualification of systems. Requirements: B.Sc/B.Eng. degree in engineering discipline, with particular emphasis mechanical or process engineering. Minimum of 6 years’ experience from biotechnology or pharmaceutical GMP manufacturing/CQV environment. Experienced in commissioning and qualifying clean utility systems. Experienced in leading teams of engineers. Demonstrated ability to work on own initiative and proactively respond to business needs. Excellent interpersonal and communication skills. Familiar with Delta-V & Navis Works an advantage. If this role is of interest to you, please apply now! #J-18808-Ljbffr
Energy & Sustainability Engineer - Contract - Life Sciences - County Waterford Would you like the opportunity to work alongside a global healthcare product manufacturer who are the leaders in the production of over-the-counter medicines? Our client, responsible for the development of a number of key and revolutionary products and with a thriving global presence is recruiting for an Energy & Sustainability Engineer to join their new project. Responsibilities include: Work with senior management and sustainability teams to define and refine sustainability goals and targets for the organization. Identify opportunities for integrating sustainable practices into biopharmaceutical operations, including areas such as energy efficiency, waste management, water conservation, and supply chain sustainability. Develop and implement initiatives to reduce the environmental impact of biopharmaceutical processes and promote social responsibility within the industry. Ensure compliance with relevant regulatory requirements, industry standards, and certifications related to sustainability. Requirements: Level 8 or higher qualification in an engineering discipline. Experience in energy management, utilities, or manufacturing. Experience in data analysis, good knowledge of statistics (regression analysis, etc.), strong experience in Excel (needs to be more than the ability to copy/paste and make a graph). Experience with ISO50001, energy auditing, and developing energy models. Experience with various utilities systems. Experience in project discovery, planning, financing, and implementation. Finance and energy forecasting. If this role interests you, apply today! #J-18808-Ljbffr
CSV Lead - Pharmaceuticals - Cork, Ireland - 12-Month Contract We are recruiting on behalf of a leading global pharmaceutical client based in the stunning surroundings of Cork, Ireland. Due to a large capital investment and multiple projects on site, the client is looking for a CSV Lead to join their team. Responsibilities: Develop CSV strategies and documents by working closely with Quality Assurance representatives. Review and obtain approval for documents as per policies and procedures. Work collaboratively with SI to ensure technical deliverables are compliant with CSV expectations, plans, and methods. Collaborate with the vendors of the PE to elaborate appropriate associated CSV packages. Work with other functional groups to ensure alignment and resolve discrepancies. Participate in Supplier Assessments, Risk Assessments, and Data Integrity Assessments. Abide by all safety requirements and procedures of the role. Requirements: 10 years of Computer System Validation experience (or equivalent experience). 5 years working in Biopharma engineering, operations, or manufacturing. 5 years’ experience with MS Office suite. If you are local to Cork and interested in discussing this position, please submit your profile, and I will be in contact at my earliest convenience. #J-18808-Ljbffr
Manufacturing Technician - Pharmaceuticals - Galway - €20 - €25 per hour Are you a Manufacturing Technician looking for your next pharmaceutical role? Our client is a global medical technology leader dedicated to transforming lives through innovative medical solutions. With a history spanning decades, the company has established itself as a pioneer in the industry, serving millions of patients worldwide. Through continuous research and development, our client has introduced groundbreaking products across various medical specialties, including cardiology, neurology, and urology. Responsibilities: Work with Manufacturing Engineers in developing, troubleshooting, standardizing, and improving existing production methods and procedures. Work on electronic troubleshooting, PLC programming, electronic hardware interfacing. Maintain a critical spares inventory for key maintenance items to minimize downtime. Assist Manufacturing Engineers in investigating and implementing new production methods. Assist Manufacturing Engineers in design methods, part sourcing, and documentation. Perform equipment qualifications and validations, including report writing. Design, specify, manufacture, test, and document production equipment, changes, and improvements. Interface with a variety of BSIL personnel and with outside vendors when necessary while performing the above. Take responsibility for preventative maintenance procedures with an assigned process or area. Communicate any concerns about work processes regarding environmental impact, health, or safety issues to their Manager. Requirements: HETAC Level 6 qualification in a relevant area with a minimum of two years relevant experience. Medical Device Manufacturing experience is highly desirable. Good technical capabilities, communication skills, teamwork abilities, and initiative. Proven ability to work well both as part of a team and independently with minimum supervision. Electrical competency is an advantage. If this role is of interest to you, please apply now! #J-18808-Ljbffr
Documentation Specialist - 12 Months + Possible Extensions - Cork The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team. Bring energy, knowledge, innovation, and leadership to carry out the following: Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the MSD EDMS (Veeva Vault) from material supplied by the Vaccine IPT SMEs. Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery. Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel). Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production. Provides to the site knowledge and experience in Quality Documentation Systems. Responsible for use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products. Responsible for maintaining the Site Master file for current effective cGMP documents on site at Brinny. Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks. Provides compliance contribution to project teams and leads small projects. What skills you will need: In order to excel in this role, you will need to have: 1-5 years’ experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment. Experience in maintaining and updating excel schedules and trackers for small projects. Advanced PC skills such as Excel, Word, PowerPoint. Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams. Knowledge and experience of GMP and GDP in a pharmaceutical environment. Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc). Desirable: Qualification in a biological science subject. Desirable: Evidence of Continuous Personal Development. If this role is of interest to you, please apply now! #J-18808-Ljbffr
Graduate Lab Systems Specialist - Dublin - 12-Month Contract One of the top 10 best companies to work in Ireland is looking for a Lab Systems Specialist for their large-scale new facility in Dublin. Is this you? An exciting project with lots of opportunities to learn new technology and develop current skills within a fast-paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting-edge technology. Responsibilities and Requirements: Support the implementation of Maximo to QC laboratories at the Dublin site. Create and maintain master data/static data in lab systems BIOVIA LES (Laboratory Execution System) and CIMS (Consumable Inventory Management System) by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met. Support the review of change controls associated with lab systems, identify system impact, and develop appropriate change actions required to support the implementation of the change, including impact to interfacing systems. Execute and document appropriate change control and/or verify changes executed by a team member are accurate within the lab system. Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up. Execute the standardisation plan and contribute to identifying opportunities to standardise. Test changes/enhancements through dry runs and receive feedback from lab users when required. If this role is of interest to you, please apply now! #LI-JS4 #J-18808-Ljbffr
