Utilities Project Engineer - Dublin, Ireland - 12-Month Contract Our client, a globally recognised pioneer in Biotechnology, is recruiting for the position of Utilities Project Engineer. 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: Responsible for the qualification of new Utility Systems and implementation of associated reliability and maintenance programs. Project management and execution of assigned projects including project prioritisation, resources management, status management and external communication. Development of detailed specifications, engineering documents, protocols and standard operating procedures. Development and implementation of maintenance programs and spare parts inventory optimisation with the introduction of new equipment. Requirements: Bachelor’s Degree in Engineering or Relevant Experience. Extensive engineering experience within a GMP environment. Mechanical capabilities within a similar hands-on technical role. Proven project management experience through all stages of project lifecycle. Experience with utility system installations and qualification. If this role is of interest to you, please apply now! #LI-WS1 #J-18808-Ljbffr
MES Contractor - Munster, Ireland - 12 Months Contract We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Munster, Ireland. Due to a large capital investment and multiple projects on site, the client is looking for a MES Contractor to join their team. Responsibilities include: Support site readiness activities to enable site start-up and ongoing operations. Configure MES Syncade to support technical testing and installation with appropriate users and systems personnel. Work with local and global IT groups to support delivery of manufacturing solutions. Analyze business processes and needs to recommend or implement changes to systems and/or procedures. Perform user requests for special support and/or extracts of data. Work in all phases of systems development cycle (define, design and deliver solution) according to company and department guidelines. Ensure compliance with Computer Systems Validation policies, standards, procedures and/or practices. Follow IT department problem management process. Assist Systems Operations, Desktops and/or telecommunications personnel on application of fixes and related troubleshooting. Identify root cause and action plan to avoid the same situation from occurring. Key requirements include: Science, Engineering or related field Extensive Automation experience Pharmaceutical industry experience of supporting Emerson Syncade system, and proficient in integrating Syncade with key manufacturing systems such as DeltaV and SAP. Computer Systems Validation in cGMP regulated operations experience Knowledge of System Development Life Cycle. If you are local to Ireland and interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience. #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
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
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
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
Strategy & Business Excellence Specialist - Dublin, Ireland - 12 Months Contract One of the top 10 best companies to work in Ireland is looking for a Strategy & Business Excellence 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 include: Support delivery supply efficiency strategy. Support Continuous Improvement, Digital tier management, Standardised work, Problem solving, and Value stream management. Support design for Six Sigma and associated certification. Support Metrics & Performance Management. Support site strategy deployment and reporting. Support PMO activities and portfolio management. Responsible for planning and execution of site communication needs. Lead Meeting Excellence program for campus. Support Maturity Assessment management and resulting actions for the campus. Lead and Support site strategic improvement activities; including fostering a culture of continuous improvement and achieving sustainable high standards of performance through training, coaching, and stakeholder engagement. Support effective business governance processes to support the day-to-day business performance. Provide mentoring and coaching to Program Sponsors, Managers and Lead End Users. Manage Program/Project lessons learned processes and the continuous improvement of the PMO. Lead projects as listed in management pillar for current year as required, assuming the role of Program. Support delivery of people and culture strategy. Support Project Recognition. Support engagement for campus. Support learning for campus, both regulatory and developmental. Support onboarding. Key requirements include: Bachelor’s degree in science, engineering, business or a related field is required. A certification in another related field (Lean Six Sigma belt, PMP, Change Management, Strategic Management or Learning) is desired. Extensive experience in delivery of any Strategy and Business Excellence systems, or a related role within a complex, matrixed organisation (Preferably GxP). The candidate will have proven decision-making ability, strong communication skills and the ability to work well and influence cross-functionally. If this role is of interest, please apply now! #J-18808-Ljbffr
Jr/Mid Level Process Engineer - Ireland - 12 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Jr/Mid Level Process Engineer. This is a fantastic opportunity to be involved with the critical investment projects both on-site and remotely. Essential Duties and Responsibilities For this role include, but are not limited to, the following: Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process Design/Author/Review/Approve/Execute Execution/development of change controls Technical input into quality notification by authoring/reviewing/approving investigations Execution of equipment/qualification validation programs; including re-qualification and re-validation Support continuous improvement through Lean Six Sigma methodologies Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums Drive compliance of 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. Desirable Experience Demonstrable experience of leading technical related projects Previous experience with Automated visual inspection systems is desired, but not essential. Evidence of continuous professional development is desirable Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Equipment and process validation If this role is of interest to you, please apply now! #J-18808-Ljbffr
Automation Engineer - Ireland - 11 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require an Automation Engineer. This is a fantastic opportunity to be involved with the critical investment projects both on-site and remotely. Essential Duties and Responsibilities: The Senior OEM engineer will be responsible for the delivery and qualification of OEM controls systems ensuring adherence to all automation, quality, and data integrity requirements. Work closely with vendors of OEM equipment to ensure deliverables meet project requirements, including the interfacing of new OEM equipment with existing site systems, including MES and Pi Historian. Work closely with the QAIT function to ensure their requirements are met in all deliverables. Participate in Hardware and Software FATs and SATs. Provide input to the development of project schedules and document trackers. Participate in and support relevant project meetings. Liaise with stakeholders on the overall project to ensure clear communication between all parties. 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. Desirable Experience: Fluent in English, written and verbal. Extensive experience in a similar role, ideally in the Pharmaceutical industry. Strong experience in one or all of the following systems: Siemens PLCs, HMIs, and Historian Software. Excellent computer skills, proficient in the use of Microsoft tools: Excel, SharePoint, Word, and PowerPoint. Strong interpersonal and communication skills (verbal and written). Relevant Computer Science or Engineering degree or equivalent. If this role is of interest to you, please apply now! #J-18808-Ljbffr
Jr/Mid Level Process Engineer - Ireland - 12 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Jr/Mid Level Process Engineer. This is a fantastic opportunity to be involved with the critical investment projects both on-site and remotely. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process Design/Author/Review/Approve/Execute Execution/development of change controls Technical input into quality notification by authoring/reviewing/approving investigations Execution of equipment/qualification validation programs; including re-qualification and re-validation Support continuous improvement through Lean Six Sigma methodologies Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums Drive compliance of 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. Desirable Experience: Demonstrable experience of leading technical related projects Previous experience with Automated visual inspection systems is desired, but not essential. Evidence of continuous professional development is desirable Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Equipment and process validation If this role is of interest to you, please apply now! #J-18808-Ljbffr
