NPI Compliance Specialist

Warehouse Specialist - Ireland, Dublin - 12 Month Contract One of the top 10 best companies to work in Ireland is looking for a Warehouse Specialist for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity 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.What you’ll do: Execute all tasks associated with WCL processes, including receiving, sampling, raw material storageQuality Inspection of incoming ConsumablesGMP Sampling of all of the sites Raw Materials, working in an ISO7 (Grade C) area, utilising Downflow Booths, Fume hoods, Bio-Safety Cabinets and Nitrogen Overlay processesSupply Manufacturing area with required materials in a timely manner to support the manufacturing schedule, ensuring a high level of internal customer service. What you’ll need: An ability to work independently and also as part of a team.High degree of problem solving ability and adherence to scheduled timelines.The Leaving Certificate is a minimum requirement, a third level qualification in logistics and/or manufacturing is preferred.Extensive GMP and Biologics manufacturing experience.  If this role is of interest, please apply now!#LI-JS4

MES Designer - Ireland, Dublin - 12 Months Initial ContractOur client, a globally recognised pioneer in Biotechnology, are recruiting for the position of MES Designer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. What you'll do: Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.Lead MBR development design reviews including liaising with Operations, Process Development and Quality functions.Responsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.Responsible for the support and ongoing development of the Client’s MES system in development of MBRs and improving the MES business process. What you'll need: Extensive experience within a similar MES designer / MES Specialist / Manufacturing Specialist role within a pharmaceutical / biotech industryExperience developing, configurating and testing of Master Batch Records (MBRs)Knowledge of regulation requirements (GMP & EH&S)Experience with PAS-X If this role is of interest, please apply now! #LI-JS3

CSA Lead - Denmark, Copenhagen - 12 Months Inital ContractOur client, a global pharmaceutical company, are looking for a CSA Lead to join their team. The company has grown to become a world leader in the development, manufacture, and marketing of innovative pharmaceutical products to alleviate some of the world’s biggest health problems. What you'll do: Lead all CSA scope execution across design, construction, installation, and turnover.Act as the primary CSA interface between the client and EPCM / EPCM‑V partners.Ensure project progress aligns with schedule, milestones, and client expectations.Review and challenge EPCM deliverables, schedules, and resource plans to ensure feasibility and compliance. What you'll need: Bachelor’s degree in Civil, Structural, Architectural, or related engineering discipline.Extensive experience in large‑scale capital projects (pharma, biotech, semiconductor, energy, or similar).Proven experience working with EPCM and EPCM/V delivery models.Strong understanding of construction sequencing, field execution, and contractor management. If you would like to apply or find out more, get in touch now!#LI-FY1

Senior Planner - Sweden, Stockholm - 12 Months Contract / PermanentHow would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you!Our client is currently seeking the skills of a Senior Planner to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!What you'll do: Lead and/or support the development of project schedules for a given project or set of projects, implementing an integrated approach with others as appropriate.Develop conceptual schedules using minimal information typically available at early development stages.Develop detailed schedules when not prepared by others, including supporting basis of schedule document(s).Conduct interactive planning sessions with project teams and other stakeholders as necessary.When requested, provide input to the review and analysis of RFP (tender invitations) and bids from design and/or construction firms and other key vendors. What you'll need: New facility builds experience (preferably Bio)Worked on builds 100 million or aboveConstruction, EPC & CQV Scheduling experience.knowledge of the software tool Primavera P6Pharma / Bio Background (Advantageous) If this role is of interest to you, please apply now!#LI-SC1

CSV Engineer - Ireland, Limerick - 12 Months Initial ContractLooking to take your career to the next level? We’re recruiting for a high-impact pharmaceutical project located near Limerick. With major capital investment experience driving various facility build projects. This is a unique opportunity for a CSV Engineer to join a global leader in the life sciences market and play a key role in shaping the future of advanced manufacturing. What you’ll do: Support operational team with Validation planning and executionEnsure Regulatory complianceAssist with system testing and verificationProvide full system lifecycle managementCarry out accurate documentation and reporting What you’ll need: Extensive CSV experience within a pharmaceutical / biotech industry.Experience with process automation systems and manufacturing technologiesKnowledge of regulatory requirementsExperience with automated system validation Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!

C&Q Engineer, Formulation - Ireland, Dublin - 12 Months Initial ContractOur client, a globally recognised pioneer in Biotechnology, are recruiting for the position of a C&Q Engineer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. What you'll do: Commissioning & Qualification of Formulation /Single Use Equipment and execution of qualification documentationGeneration of all C&Q test documentsProvide technical assistance during investigations and system design.Ensures the C&Q schedule is maintained.Ensures Startup of equipment/utilities is completed in a safe and coordinated manner. What you'll need: Several years C&Q experience withing a biologics manufacturing capacityFormulation equipment experience.Experience with both C&Q protocol development and executionFAT experience highly desirableGood communication skills If this role is of interest, please apply now!#LI-EP1

C&Q Lead Engineer, Formulation - Ireland, Dublin - 12 Months Initial ContractOur client, a globally recognised pioneer in Biotechnology, are recruiting for the position of a C&Q Lead Engineer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. What you'll do: Commissioning & Qualification of Formulation /Single Use Equipment and execution of qualification documentationGeneration of all C&Q test documentsProvide technical assistance during investigations and system design.Coordinates and Supervises all C&Q activities on their systems.Ensures the C&Q schedule is maintained. What you'll need: Several years C&Q experience withing a biologics manufacturing capacityFormulation equipment experience.Experience with both C&Q protocol development and executionFAT experience highly desirableGood communication skills If this role is of interest, please apply now! #LI-EP1

NPI / TT QA Specialist - Ireland, Dublin - 12 Months Initial ContractOur client, a globally recognised pioneer in Biotechnology, are recruiting for the position of NPI / TT QA Specialist. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. What you'll do: Quality Point of Contact during NPI and Tech Transfer activitiesQuality oversight for Process development and validationQuality oversight for Change controls and deviationsEnsure compliance to client’s and regulatory safety standards What you'll need: Extensive experience within relevant QA rolesAseptic manufacturing experienceNPI / Tech transfer project experienceStrong problem-solving skills If this role is of interest, please apply now! #LI-LW1

Quality Technican - UK, Newport - 11 Month ContractDo you want to work at a leading global pharmaceutical manufacturer? If so, this is the assignment for you! Our global client with manufacturing facilities in Southern Ireland, is currently investing significantly in their manufacturing programme. This state-of-the-art facility houses high-technology and next-generation processes to produce OTC and Oral Care Products that are distributed throughout the Globe. As such, they are looking for a Quality Technican to join their Newport based project.What you'll do: Perform support tasks related to the processing and analysis of test specimens.Accurately complete assigned duties in a timely manner.Log and scan samples into proprietary applications/databases, update task management systems, perform initial quality controls, and store samples appropriately.Process sample data received from clients and monitor data completeness, providing feedback to the Technical Account Executive.Perform in-house quality measurements and calibration of scientific equipment. What you'll need: Lab work to ISO 17025 standard.Strong pipetting skills and experience.Experience and comfort level working with chemicals in a lab setting.Demonstrates effective communication skills to convey and receive information.Proficient in MS Office Suite and basic computer skills. If this role is of interest to you, please apply now!#LI-TE1