James Smithson

QC Analyst Microbiology - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a QC Analyst Microbiology 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: Performing Sterility testing on Drug Product samplesPerforming Bacterial Endotoxin Testing on Drug Product, Drug Substance, Raw Material and Utility samples within required hold times.Performing Bioburden testing on Drug Substance, Raw Materials and Utility samples within required hold times. Performing Growth Promotion testing of media lots entering the laboratory. What you’ll need: The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.Extensive experience in a pharmaceutical / healthcare laboratory or related technical function.A strong background in Microbiology and aseptic manufacturing is desirable but not essential.The successful candidate must demonstrate excellent written and verbal communication skills. If this role is of interest, please apply now!#LI-JS4

Program Manager - UK, Surrey - 12 Month ContractWe are looking for an experienced Program Manager for a fantastic 12 month contract based in Surrey. 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: Lead the programme from initial definition through planning, delivery, commissioning, and handover.Hold accountability for final engineering aspects, ensuring design intent, technical standards, safety requirements, and compliance obligations are met.Understand and oversee the full commissioning process for R&D and laboratory environments, ensuring readiness for functional testing, validation, and operational ramp-up.Develop and maintain integrated programme schedules, resource plans, and performance baselines. What you’ll  need: Extensive experience managing major capital programmes, ideally within R&D, laboratories, scientific facilities, pharma, defence, advanced engineering, or highly regulated technical environments.Strong understanding of engineering processes, design assurance, and technical governance.Demonstrable exposure to commissioning activities within complex facilities.Proven ability to lead multidisciplinary teams through full lifecycle delivery If this role is of interest to you, please apply now! #LI-JS4

Tech Transfer Engineer (Downstream) - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Tech Transfer 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: Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the MPCC Cruiserath.Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.Identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.Generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scaleProvide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution What you’ll need: Minimum BSc or equivalent extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form. If this role is of interest, please apply now!#LI-JS4

CSV Engineer - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a 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

Senior Scientist - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Senior Scientist 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: Provide technical oversight and ownership of analytical methods. This includes partnering with analytical development to ensure method readiness for validation, assisting with validation protocols, gathering data generated by analytical development/QC labs and assisting with validation reports.Lead complex projects and lead a team of scientists to meet deadlines and collaborate with key stakeholder groups.Provide technical oversight of method revisions.Lead method transfers to QC GMP labs within and outside of the company. What you’ll need: Specific Knowledge, Skills, Abilities, etc:Demonstrated trouble shooting and hands on experience with protein separation methods, for example, CE_SDS or iCIEF Electrophoresis, HPLC and UPLC Chromatography including Size-Exclusion chromatography, ion exchange and UVIS spectroscopy based technologies.Good understanding of the fundamentals of protein characterisation methods such as peptide mapping, and carbohydrate analysis.Experience leading complex projects, projects teams and meeting tight deadlines If this role is of interest, please apply now!#LI-JS4

Utilities SME - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Utilities SME 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: Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, European directives, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements.Developing Project Requirements Documents (PRD’s) and User Requirements Specs (URS) for new equipment and modifications to existing equipment and systems from concept through supporting installation with the collaboration of stakeholders.Participates in system design reviews, equipment selection & Hazops to ensure the design and Project deliverables meet company requirements, site Engineering specifications and SOP’s.Responsible to evaluate all the drawings and technical data required for Utilities systems to be handed over to the site Engineering doc control for implementation of the project. What you’ll need: The successful candidate must possess a Bachelor/master’s in mechanical engineering discipline.Extensive experience working in pharmaceutical manufacturing facilities in a maintenance engineering or utilities role in a similar scale pharmaceutical manufacturing site with 24x7 operations.Extensive knowledge of Critical Utilities systems in a pharmaceutical facility such as Boilers, steam generation & distribution, chillers, cooling towers, Fire main, Fire Suppression, softened water, RO, WFI, Chemical dosing, WWTP, HVAC, Coldrooms, Freezers, etc.Professional Member of Engineering organisation such as IEI or IET with CEng status or on route to become chartered. If this role is of interest, please apply now!#LI-JS4

Principal Scientist (Downstream) - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Principal Scientist  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: Identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.Provide process subject matter expertise for regulatory inspections and other interactions with regulatory agencies (e.g. health authority query support - timely responses / data gathering etc.), representing the Cruiserath site.Provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site. What you’ll need: Minimum BSc or equivalent with extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry.Demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form. If this role is of interest, please apply now!#LI-JS4

QA Analyst - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a QA Analyst 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 and assist in batch release testing, technical transfer and co-validation activities.Accurately documenting laboratory work.Data review based on demonstrated proficiency on assays.Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports. What you’ll need: Experience in the following analytical techniques would be an advantage: Aseptic Techniques, Cell Culture, Cell-based Bioassays and ELISA.The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline.The successful candidate must demonstrate an ability to work independently in assay execution and recognise anomalous trends or results.The successful candidate must demonstrate problem solving ability, as well as the ability to prioritise objectives from multiple projects and adhere to scheduled timelines. If this role is of interest, please apply now!#LI-JS4

QC Quality Systems Specialist - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a QC Quality Systems 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: Lead and manage QC Investigations assignedFacilitate root cause analysis and problem solving sessionsComplete the generation of associated investigation reportsDetermine and create CAPA’s, Effectiveness Reviews, and Supplemental Tasks as requiredPresent investigations at IRB to senior management What you’ll need: Proficiency in communication and collaboration at a variety of levelsProven success working well in a team environment with flexibility to react to changing business needsDemonstrated problem solving, project management abilityExcellent time management and organisational skillsExcellent technical writing skills If this role is of interest, please apply now!#LI-JS4