Caroline O`Sullivan

CSV Engineer - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for CSV Engineer 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: Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports. What you’ll need: Bachelor's degree in Computer Science, Engineering, or a related field.Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.Extensive experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.Familiarity with validation methodologies, including risk-based validation approaches. If this role is of interest, please apply now!#LI-JS4

Information Scientist (Content Analysis) - UK, Slough / Remote - 12 Month ContractWe are looking for an experienced Information Scientist for a fantastic 12 month contract based in Slough. You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease. This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first. What you’ll do: Design and implement workflows for literature mining, summarization, and trend analysis using AI/NLP tools.Develop and maintain external information endpoints, ensuring FAIR principles (Findable, Accessible, Interoperable, Reusable) and interoperability.Apply machine learning and large language models (LLMs) to enhance information retrieval and automate content classification.Support pharmaceutical R&D processes. What you’ll  need: Experience or interest in NLP and LLM applications (transformers, Retrieval-Augmented Generation, prompt engineering)Familiarity with data visualisation and scientific communication toolsKnowledge graph and ontology managementPython and AI frameworks for text analytics If this role is of interest to you, please apply now! #LI-KT1

CQV Lead (Facility HVAC EM BMS) - Denmark, Copenhagen - 12 Months Initial ContractOur client, a global pharmaceutical company, are looking for a CQV 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: Provide input and guidance for planned CQV activities related to federated scheduleParticipate in Facility (HVAC EM BMS) schedule and planning activities to support and amend existing scheduleReview and participate in planned equipment and system walk downs and SATGive oversight, guidance, and support in application of governance and expectationsEnsuring that Commissioning, Qualification, and Validation (CQV) activities meet project and regulatory requirements What you'll need: Strong Process Background within API ManufacturingPharma Experience and background is essentialRelevant experience in required fieldExperience of working in a cross-functional team If you would like to apply or find out more, get in touch now!#LI-LH1

CQV Lead (Black Utilities) - Denmark, Copenhagen - 12 Months Initial Contract Our client, a global pharmaceutical company, are looking for a CQV 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: Provide input and guidance for planned CQV activities related to federated scheduleParticipate in Black Utilities schedule and planning activities to support and amend existing scheduleReview and participate in planned equipment and system walk downs and SATGive oversight, guidance, and support in application of governance and expectationsEnsuring that Commissioning, Qualification, and Validation (CQV) activities meet project and regulatory requirements What you'll need: Extensive industry experienceStrong Process Background within API ManufacturingPharma Experience and background is essentialClient experience with skills in creating and reviewing procedures and strategy. If you would like to apply or find out more, get in touch now!#LI-LH1

CQ Lead (Electrical & Instrumentation) - Denmark, Copenhagen - 12 Months Initial ContractOur client, a global pharmaceutical company, are looking for a CQ 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: Provide input and guidance for planned CQV activities related to federated scheduleParticipate in E&I schedule and planning activities to support and amend existing scheduleReview and participate in planned equipment and system walk downs and SATGive oversight, guidance, and support in application of governance and expectations What you'll need: Extensive industry experience Strong Process Background within API ManufacturingPharma Experience and background is essentialExperience of working in a cross-functional team If you would like to apply or find out more, get in touch now!#LI-LH1

Senior Validation Engineer - US, Seattle - 4 Months Initial ContractOur client, a global biotechnology organisation, is recruiting for a Senior Validation Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a Senior Validation Engineer to help expand our client's biotech operations throughout Europe. As the Senior Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.What you’ll do: Lead the planning, development, and execution of EMPQ protocols (IQ/OQ/PQ) for new and existing equipment, utilities, and process systems.Write clear, compliant, and technically robust EMPQ protocols aligned with GMP, GAMP 5, and site validation master plans.Execute EMPQ protocols on the manufacturing floor, ensuring accurate data capture and adherence to safety and GMP requirements.Ensure validation activities comply with FDA, MHRA, EU Annex 15, and other applicable regulatory frameworks.Partner with Engineering, Facilities, Manufacturing, Quality Assurance, and external vendors to ensure equipment readiness and qualification success. What you’ll need: Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.Extensive experience in validation within GMP-regulated industries (pharmaceutical, biotech, medical devices, or similar).Proven expertise in EMPQ, including authoring and executing IQ/OQ/PQ protocols.Strong understanding of regulatory requirements: FDA 21 CFR Parts 210/211, EU GMP, Annex 15, GAMP 5.Exceptional technical writing skills and ability to produce clear, audit-ready documentation. If this role is of interest, please apply now!#LI-CO1

Validation Engineer - US, Seattle - 4 Months Initial ContractOur client, a global biotechnology organisation, is recruiting for a Validation Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a Validation Engineer to help expand our client's biotech operations throughout Europe. As the Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.What you’ll do: Plan, develop, and execute qualification activities (URS, RA, IQ/OQ/PQ) for QC laboratory instruments and systems.Author clear, compliant qualification protocols and reports for QC equipment.Maintain qualification status throughout the equipment lifecycle, including periodic reviews, requalification, and retirement.Ensure QC equipment qualification meets regulatory requirements (FDA, MHRA, EU GMP, Annex 15).Work closely with QC analysts, QA, Engineering, IT, and vendors to ensure equipment readiness and compliance. What you’ll need: Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field.Experience in a GMP-regulated QC laboratory environment (pharmaceutical, biotech, ATMP, or medical devices).Hands-on experience with QC equipment qualification (IQ/OQ/PQ).Strong understanding of analytical laboratory instruments (e.g., HPLC, GC, UV-Vis, PCR, balances, incubators).Excellent technical writing and documentation skills. If this role is of interest, please apply now!#LI-CO1

QA/QC Welding Inspector - Denmark, Copenhagen - 12 Month Contract  Our client, a global pharmaceutical company, are looking for a QA/QC Welding Inspector 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: Verify piping fabrication and installation against approved isometrics, P&IDs, weld maps, material specifications, and project standardsInspect welding activities including fit-up, root pass, hot pass, fill and cap ensuring adherence to specificationReview and approve and amend welding documentationConduct visual weld inspections (VT) and coordinate NDT activities (RT, PT, MT, UT) with third-party inspectors, including the EPCMMonitor weld traceability ensuring full linkage between welds, materials, NDT results, and turnover documentation What you'll need: Strong knowledge of welding processes (GTAW, SMAW, GMAW, orbital welding).Ability to interpret WPS, PQR, WPQ, weld maps, and consumable requirements.Skilled in visual weld inspection (VT) and coordination of NDT (RT, PT, MT, UT).Understanding of material traceability, heat numbers, MTRs, and stainless-steel handling.Mechanical Engineering (degree or diploma). If you would like to apply or find out more, get in touch now!#LI-LH1

Senior Project Manager - US, Remote Working - Permanent ContractQCS staffing are partnered with one of the world’s top AI infrastructure companies. As an organisation, our client are leading a new era in cloud computing to serve the global AI economy. They create the tools and resources for their customers requirement to solve real-world challenges and transform industries, without massive infrastructure costs or the need to build large in-house AI/ML teams. To support our client’s continued growth, they are currently looking to hire a Senior Project Manager to work remotely within the US.What you’ll do: Oversee full lifecycle delivery of AI data center construction projects, including planning, permitting, procurement, execution, and handover.Work closely with engineering teams to translate high-density compute and liquid cooling requirements into construction-ready documentation.Build strong relationships with contractors, local authorities, utility partners, and equipment suppliers.Ensure adherence to safety policies, local building regulations, and environmental standards. What you’ll need: Extensive construction project management experience, with at least 5 years in mission critical facilities (data centers, semiconductor, HPC, or similar).Demonstrated expertise in AI data centers, HPC environments, or other high-density compute facilities.Hands-on experience with liquid cooling systems (direct to chip, immersion cooling, or advanced heat exchanger systems).Proven track record of delivering large-scale construction projects (>$100M preferred) in fast-paced, technology-driven environments. If this role is of interest to you, please apply now! #LI-IG1