CQ Documentation Engineer

Process Engineer (Drug Product) - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Process Engineer 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. What you’ll do: Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.Monitoring and analysis of process data during the manufacturing.Assisting in the development of the manufacturing process for new products.Providing operational technical support for process related issue resolution. What you’ll need: Third level degree in a relevant engineering, science or technical discipline required.Masters Qualification in relevant technical discipline desirable.Extensive experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry.Experience in new product introductions to Biologic facilities desirable. If this role is of interest, please apply now!#LI-JS4

Single Use Process Scientist - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Single Use Process Scientist 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. What you’ll do: Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.Monitoring and analysis of process data during the manufacturing.Assisting in the development of the manufacturing process for new products.Providing operational technical support for process related issue resolution. What you’ll need: Third level degree in a relevant engineering, science or technical discipline required.Masters Qualification in relevant technical discipline desirable.Extensive experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry.Experience in new product introductions to Biologic facilities desirable. If this role is of interest, please apply now!#LI-JS4

CQV/Qualification Engineer - Dortmund, Germany - 2-3 Months Initial ContractThis innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. Notably, their current project in Germany is centred around implementing single-use technology, which enhances efficiency and flexibility in the production process. What you'll do: Develop and execute qualification documents including URS, risk assessments, IQ/OQ protocols, reports, and supporting documentation.Collaborate with stakeholders to ensure timely review and approval of documentation.Report progress, manage timelines, and ensure alignment with project milestones. What you'll need: Extensive experience in CQV/qualification engineering within the biopharmaceutical industry.Proven track record qualifying equipment such as bioreactors, ultra-filtration, chromatography, and related systems.Strong knowledge of GMP, regulatory requirements, and risk management principles.Fluent German speaker (mandatory). If this role is of interest to you, please apply now!#LI-FY1

C&Q Engineer - Ireland, Dublin - 12 Month ContractWith more than 2,000 employees, more than 300 million units per year, and a lot of innovative medicines in the pipeline, no wonder our client is one of the largest production units in the world! Our client produces, packs and distributes in a high-tech environment, sterile injectable medicines. More than 1 million injectable medicines are produced, packaged and distributed every day. Their destination: 170 countries, worldwide!  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 C&Q Engineer to work on an exciting CapEx project in Dublin on an initial 12 month contract. As C&Q Engineer you will play a key role in the successful delivery of a new state of the art facility.What you'll do: 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.Track and confirm closure of actions items identified through FAT, HAZOP, Design Qualification and other reviews. What you'll need: B.Sc/B.Eng. degree in engineering discipline, with particular emphasis mechanical or process engineering.Extensive experience from biotechnology or pharmaceutical GMP manufacturing/CQV environment.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! #LI-BP1

Data Governance Specialist - Spain, Remote Working - 6 Months Initial ContractOur client, an international IT service provider, is seeking a Data Governance Specialist to join them as a contractor, with the option to work fully remote or onsite within the charming region of Valencia. Starting at an initial 6 month contract, multiple extensions are expected and there is great, long-term potential. What you'll do: Assess current data governance practices and identify gapsDesign and implement Purview components aligned within the project objectivesCollaborate with teams to onboard internal usersDevelop governance workflows and stewardship models What you'll need: Master’s or bachelor’s degree in computer science, Data Science, Computer Engineering, Information Technology, or related fields.Builds constructive relationships and handles conflicts professionally.Clearly conveys ideas in written and verbal form; actively listens; ensures information is shared effectively.Works constructively with colleagues of diverse backgrounds; values individual and cultural differences. If this role is of interest to you, apply now!#LI-AM1

Data Management Specialist - Spain, Remote Working - 6 Month ContractOur client, an international IT service provider, is seeking a Data Management Specialist to join them as a contractor, with the option to work fully remote or onsite within the charming region of Valencia. Starting at an initial 6 month contract, multiple extensions are expected and there is great, long-term potential. What you'll do: Design and implement modern, scalable, and secure data pipelines and data architectures.Support infrastructure automation through Infrastructure-as-Code (IaC) practices using tools like Terraform.Design, build, and maintain ETL/ELT pipelines to ingest structured and semi-structured data (APIs, files, databases, etc.).Apply best practices for identity management, RBAC, and secret management. What you'll need: Extensive experience as a Data Engineer with proven expertise in designing and implementing cloud and on-premises data solutions.Strong experience in at least one public cloud platform (Azure, AWS, or GCP) with working knowledge across multiple clouds.Proficiency in modern ETL/ELT pipelines, Data Lakes, Delta Lakes, and data integration solutions.Experience with data modeling tools and working in distributed data architecture teams (on-premises or cloud). Familiarity with data visualization tools such as Tableau, Power BI or D3.js If this role is of interest to you, apply now!#LI-AM1

Delta V Automation Engineer (Upstream) - US, North Carolina - 12 Month ContractOur client, a global pharmaceutical manufacturing organization are looking for a talented Delta V Automation Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States. What you'll do: Attend regularly scheduled project status meetings with FDBN Automation engineers and the System Integrator.Review life cycle documentation post execution.Initiate and drive delivery of Automation changes in support of CAPEX project requirements.Review and approve Kneat documents including: DeltaV software FATs, Automation CommissioningTest Protocols, software OQs, and Automation Change Assessments. What you'll need: Extensive direct experience working with Emerson DeltaV DCSExperience in a cGMP pharmaceutical facility is requiredWorking knowledge of lifecycle documentation and CSV concepts and principles is requiredExperience with Kneat validation software is desired If you are interested, please apply now for immediate consideration and further information.

Project Engineer - Ireland, Dublin - 12 Months Initial ContractDo 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 Project Engineer. What you'll do: Provide project engineering services in support of the commissioning and qualification of a drug substance and drug product manufacturing facility.Preparation of project related deliverables such as schedules, work plans, equipment cost tracking·Coordination of project activities between stakeholdersManage installation / start-up / testing of key equipment systems through OQ completion. What you'll need: Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Engineering.Extensive post academic engineering experience in relevant aseptic/sterile processing design and start-up environment.Demonstrated ability to be a team playerExcellent communication/presentation/organizational skills If this role is of interest to you, please apply now!#LI-JD1

Delta V Automation Engineer (Downstream) - US, North Carolina - 12 Month ContractOur client, a global pharmaceutical manufacturing organization are looking for a talented Delta V Automation Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States. What you'll do: Attend regularly scheduled project status meetings with FDBN Automation engineers and the System Integrator.Review life cycle documentation post execution.Initiate and drive delivery of Automation changes in support of CAPEX project requirements.Review and approve Kneat documents including: DeltaV software FATs, Automation CommissioningTest Protocols, software OQs, and Automation Change Assessments. What you'll need: Extensive direct experience working with Emerson DeltaV DCSExperience in a cGMP pharmaceutical facility is requiredWorking knowledge of lifecycle documentation and CSV concepts and principles is requiredExperience with Kneat validation software is desired If you are interested, please apply now for immediate consideration and further information.